Happy New Year - What are your resolutions?

The start of a new year is traditionally a time for New Year Resolutions, where we make a list of things that we will not do, will do more of, or a list of things that we want to try in the next 12 months.

Some of us will have broken some of our resolutions already and we are only in the first week of the new year. But don't worry, we won't tell anyone and you can re-start them again now.

If you plan to Quit Smoking, give up caffeine or chocolate, or aim to get more exercise there is a wealth of support and information available for whatever you decide.

Here are some resolutions that you might like to consider

• Know your HIV status by getting tested
• Carry and Use condoms next time you have sex
• Reduce the amount of sexual partners that you have

If you have any questions or need any advice on your New Year Resolutions, please call a member of the team on the telephone numbers above

 

We are not responsible for content of external web sites and only offer links to other sites as an alternative source of information.

Posted: January 6 by Pete (updated January 6)

Warning over HIV home test kits

Illegal home testing kits for HIV are giving people incorrect results, the Medicines and Healthcare products Regulatory Agency (MHRA) has warned.

It said there were issues with other tests for sexually transmitted diseases which were legal but might also be inaccurate.

The MHRA is investigating a UK website which is selling the tests.

The Health Protection Agency has written to some of those affected to say the tests are unreliable.

Sales records gathered during the investigation showed that about 500 tests for sexually transmitted diseases - such as HIV, chlamydia and syphilis - had been sold.

It warned that as well as home HIV tests being against the law, the other tests did not meet European regulations.

Concern

 

Susanne Ludgate, MHRA clinical director of devices, said: "We're concerned that there may be a number of self-test kits being sold online that may not be compliant with the relevant piece of legislation and we're urging people not to consider the internet as a method of anonymous testing.

"These kits may be unreliable and there is a significant risk they could be providing the user with a false result.

"The instructions for use might also be incorrect or confusing and not adequate for someone trying to use the kit in their home."

She said people should check for the "CE mark", which shows the tests have been approved.

The Health Protection Agency has contacted those known to have ordered the kits.

Dr Fortune Ncube, from the HPA's blood borne viruses department, said: "If anybody feels they have put themselves at risk they should contact their local GP or go to their most convenient GUM clinic, where they can receive a full screen for all STIs, including HIV.

"Rapid and confidential tests, as well as sexual health advice, are available through the NHS without charge."

This information was supplied by the BBC

We are not responsible for content of external web sites and only offer links to other sites as an alternative source of information. 

 

Posted: October 28, 2011 by Pete (updated December 14, 2011)

SHEA Releases new poster for Black History Month

SHEA have recently released a new poster in 16 languages encouraging BME communities to 'Talk to us about testing' for Chlamydia, Pregnancy and HIV.

The poster will be appearing in Sexual Health Services (GUM) clinics across the county and in other sexual health locations.

If your local Sexual Health clinic does not have a poster, please contact us with details and we will send a poster for them to display.

Posted: October 26, 2011 by Pete (updated October 26, 2011)

HIV treatment and children – avoid crushing Kaletra tablets

 

Using crushed Kaletra (lopinavir/ritonavir) tablets leads to reduced levels of the drug in the blood of HIV-positive children, US research shows.

Kaletra, a boosted protease inhibitor, is available in a paediatric tablet containing 100mg lopinavir and 25mg ritonavir.

However, some children have difficulty swallowing tablets, and crushing or breaking the tablets can make them easier to take.

But researchers found that children treated with crushed Kaletra had levels of the drug in their blood reduced by up to 40%. This could mean that HIV treatment fails to suppress viral load, possibly leading to resistance.

The researchers conclude: “Increased doses and therapeutic drug monitoring are needed to ensure adequate lopinavir/ritonavir exposure in patients requiring crushed Kaletra tablets. The reduced exposure with crushed Kaletra tablet dosing reinforces the need to discourage this dosing practice.”

 

Taken from HIV Weekly, 28 September, 2011

Posted: September 28, 2011 by Nozizwe

House of Lords says UK needs new national HIV prevention campaign, bigger push for testing

Keith Alcorn Published: 01 September 2011 Lord Fowler, Chairman of the House of Lords Select Committee on HIV & AIDS in the UK.  

The United Kingdom government must give much greater priority to HIV prevention, and consider a new national campaign to inform the general public of the risks of HIV infection, according to a report issued today by the House of Lords Select Committee on HIV & AIDS in the UK.

Its report warns of “potentially huge cost implications…of failing to deal effectively with the epidemic,” and stresses that ”the Government should ensure that HIV and AIDS is a key public health priority.”

Lord Fowler said that while up to £750 million a year is being spent on treatment, the Government is spending less than £3 million a year on prevention campaigns.

“I know these are difficult times, but if you were to try to find one good investment, it would be to spend more on prevention, because that investment prevents the treatment costs.”

The Select Committee was established in December 2010 in order to review the status of HIV responses in the United Kingdom and make proposals for improvements. Its recommendations are not binding on the Government, but do reflect the fruits of extensive hearings and submissions by more than 80 organisations which gave evidence. 

The committee was chaired by Lord Fowler, who as Health Secretary in 1986 launched the `Don’t Die of Ignorance” government information campaign on AIDS.

Prevention and testing must expand

Unsurprisingly, the committee has recommended a new national HIV campaign, or at the very least, integration of HIV prevention messages into all future sexual health campaigns.

Existing prevention activities targeted towards gay men and Africans need to be better funded, but a wider range of evidence-based approaches need to be adopted, and the effectiveness of these activities should be evaluated independently.

But it is HIV testing that the committee sees as the priority if HIV prevention efforts are to be improved.

“In particular, we want to see a new emphasis on people getting tested,” said Lord Fowler. “It is ridiculous that we have about a quarter of people with HIV who don’t know they have it. It’s bad for them, and it’s bad for public health.”

Testing needs to be offered outside sexual health clinics, and people need to be encouraged to test for HIV.

Opt-out HIV testing should be routinely offered to all patients registering with a new general practitioner, and to all patients admitted to hospital, in areas with a high background HIV prevalence. It should also be offered to all patients diagnosed with TB, and all clinicians should be better trained to recognise potential symptoms of HIV infection and AIDS, the committee says.

The committee also wants to see an end to the ban on home testing for HIV, subject to the development of careful regulations that will outlaw poor-quality testing kits and ensure that users can be linked into sexual health services.

The report criticises the current government approach to sex and relationships education in schools, which allows schools and parents to opt out. Schools should be legally obliged to provide sex and relationships education, this should include information on HIV, and teachers should be better trained to provide it, the committee recommends.

Another reason for a national campaign on HIV is to address prejudice and ignorance about the infection, the committee says. Work with faith leaders will be essential to reach African communities, and the development of people living with HIV as advocates will also play an important role in breaking down stigma.

Treatment

Treatment services should build stronger links with GPs, so that some elements of HIV care can be taken over by GPs, and clinics need to move towards offering evening and weekend clinics, home delivery of drugs, and email and telephone consultations, in order to reduce the burden on specialist services.

Procurement of antiretroviral drugs should be conducted on a national basis, the committee recommends, in order to achieve the greatest possible economies of scale, and to ensure that regions of the country outside current bulk purchasing agreements are not being over-charged. However the committee also notes that the priority in purchasing must be provision of drugs that are well tolerated and easy for patients to take.

People not currently entitled to free HIV treatment in the UK should receive free treatment.

Testing and treatment in prisons also needs to be improved, including national standards for treatment services within prisons.

The committee also recommends that priority should be given into research to evaluate the impact of treatment on new infections in the UK. It also recommends that research into the use of pre-exposure prophylaxis with antiretroviral drugs to prevent infection in HIV-negative people should be a funding priority for the National Institute for Health Research and the Medical Research Council.

Deborah Jack, Chief Executive of the National AIDS Trust, welcomed the recommendations.  "It is essential that HIV prevention is treated as public healthy priority by the Government and is a core element of new local public health strategies.

"The report covers more than 50 recommendations for action and it’s important for the Government to act on these – not in a piecemeal fashion – but with a cohesive strategy for HIV which brings all these elements together."

 

Taken from Aidsmap, 1 September,2011

Posted: September 5, 2011 by Nozizwe (updated October 26, 2011)

World Aids Day - 1st December

World Aids Day is observed on 1st December every year throughout the world. In every country there are people living with HIV.

HIV stands for the Human Immunodeficiency Virus. It is a virus which attacks the body's immune system — the body's defence against diseases.

 

HIV can be passed on through infected bodily fluids, most commonly via sex without a condom or by sharing infected needles, syringes or other injecting drug equipment.

There are now more people than ever living with HIV in the UK — more than 90,000 — with around a quarter of those unaware they have the virus.

Here are a few more facts about HIV in the UK:

• Over 90% of people with HIV were infected through sexual contact
• You can now get tested for HIV in some clinics using a saliva sample
• HIV is not passed on through spitting, biting or sharing utensils
• Only 1% of babies born to HIV positive mothers have HIV
• You can get the results of an HIV test in just 15-20 minutes in some clinics
• There is no vaccine and no cure for HIV

Have any of these facts come as a surprise? There is still loads more you can learn about HIV in the UK by visiting HIVaware — the interactive new website which provides all the information everyone should know about HIV. HIVaware gives you facts and stats on HIV, busts common myths and answers your frequently asked questions.

Take your first step to Acting Aware by visiting HIVaware today.

NHS Choices website has information about HIV here.

We are not responsible for content of external web sites and only offer links to other sites as an alternative source of information. 

 

Posted: December 1, 2011 by Pete (updated January 6)

Fish Pedicures HIV Risk – A Red Herring

The Sun ran the story on the front page and a full page inside, the Daily Mail splashed it across several pages and the story was taken up with international media.

“Fish pedicures: Information for the Public” issued by the Health Protection Agency (HPA) was the source that caused the media frenzy. Along with skin conditions such as psoriasis and eczema, diabetes and legs recently waxed, HIV and hepatitis B and C, ‘may mean you should not have a fish pedicure,’ say the HPA. The information was originally meant to protect people with the above conditions from the small risk of bacterial infection.

It was however the possibility of transmission of hepatitis and HIV to other users of the foot spas, that caused the media to latch on to the story, even though the risk was quantified as ‘low but could not be excluded’ the media ran this as ‘HIV could be spread through fish pedicures’.

‘It’s rubbish’ says Deborah Jack of the National AIDS Trust. ‘There is no risk of HIV being passed on through a fish pedicure and these claims do nothing but undermine public understanding. We are really frustrated by the concern this could give people. It distracts from the real risks with HIV and feeds into the stigma of catching HIV from everyday situations.’

There has never been a recorded case of blood-borne viruses such as HIV transmitted in such a way, even in the event of a bleed into a spa and then a person with an open cut on the foot using the spa immediately afterwards. Experts say that the virus does not survive for long outside of the human body. The concentration of the virus would be highly reduced when diluted in water. Fish cannot be infected with HIV.

‘At a time when knowledge of HIV is declining, it is crucial for the public to be aware of the facts so they can protect themselves from real transmission risks – and not get preoccupied with sensationalist and inaccurate reports. We are concerned the HPA’s guidance has been misleading in terms of HIV risk and we are working with them to clarify the facts.’

NAT have launched a new resource website which provides all the information that the general public should know about HIV, particularly important it says in light of their recent Ipsos MORI research which showed a large and increasing gap in public knowledge.

Information taken from Baseline 

Here's what NHS Choices has to say about Fish Pedicures

Image from

We are not responsible for content of external web sites and only offer links to other sites as an alternative source of information. 

Posted: November 24, 2011 by Pete (updated December 1, 2011)

Breast Cancer Awareness Month - Men get it too..!

Breast cancer in men is rare, but there are 300 new cases in the UK every year.

Most of the information that is available for women apply just as much to men with breast cancer. The single biggest risk factor in men in age, but other factors like history of brest and other cancers, exposure to radiation, high oestrogen levels and other factors.

A diagnosis of breast cancer can be particularly difficult for men. You may feel confused and isolated. It is very common to hear about breast cancer in women but not at all common to hear about it in men. Your consultant may know other men with breast cancer that you could talk to or contact the Breast Cancer Care charity for support.

Further details can be found on the websites below, or contact us for more information or to discuss this condition.

This information was taken from Cancer Research UK

The NHS has details of Male Breast Cancer

The Breast Cancer Care website has information on female Breast Cancer and contact details for support on male Breast Cancer.

We are not responsible for content of external web sites and only offer links to other sites as an alternative source of information.

Posted: October 26, 2011 by Pete (updated November 4, 2011)

HIV gene therapy – progress towards a cure

A new gene therapy represents “significant progress towards a ‘functional cure’” of HIV, investigators are claiming.

A functional cure for HIV would consist of a treatment intervention that could stop or control HIV replication without the need for lifelong treatment, even though HIV was not eliminated from the body.

SB-728-T is a one-off treatment that genetically edits CD4 cells, making them less vulnerable to infection with HIV.

The therapy was investigated in nine patients who were taking HIV therapy. Despite having an undetectable viral load, their CD4 cell count remained low. Treatment with SB-728-T led to an increase in CD4 cell count, and genetically modified cells were found in both the blood and in gut mucosa – an important ‘reservoir’ for HIV.

A second small study involved six patients. They interrupted their HIV treatment for twelve weeks after being treated with SB-728-T.

Viral load remained undetectable in one patient after receiving SB-728-T therapy.

Research into the therapy will continue.

Our publication HIV treatment update recently featured an article about HIV gene therapy written by one of the trial participants.

 

Taken from HIV Weekly, 28 September, 2011

Posted: September 28, 2011 by Nozizwe (updated October 26, 2011)

Starting HIV treatment – recovery of the immune system

Older age is associated with poorer recovery of the immune system after starting HIV treatment, a French study shows.

Another factor connected with a weaker improvement in CD4 cell count was a strong immune response to the infection cytomegalovirus (CMV).

Most people experience an increase in their CD4 cell count after they start HIV treatment. But this isn’t always the case.

It’s already known that the functioning of the immune system deteriorates with age. In addition, a strong response to viral infections can have an impact on the immune system.

In this recent study, researchers in Paris showed that older people (those aged over 65) had a poorer CD4 cell increase after starting HIV treatment than younger people.

CMV is very common, but in people with a reasonably strong immune system it doesn’t tend to cause any problems. It can cause serious illness if a person has a very low CD4 cell count.

But the researchers also found that a strong immune response to the infection was associated with lower increases in CD4 cell count after initiating HIV therapy. This was especially the case for older people.

The researchers believe their findings are “important for the long-term clinical management of the aging HIV-infected population.”

Early HIV treatment is especially recommended for older people in current UK guidelines.

For more on ageing and HIV, including features, news and news from other sources, visit our ageing and HIV topics page.

 

Taken from HIV Weekly, 28 September, 2011

Posted: September 28, 2011 by Nozizwe

Fluctuating symptoms have major impact on quality of life and fitness to work, survey finds

Common but non-specific symptoms of uncertain cause can dominate the day-to-day life of some people with HIV, a survey by the National AIDS Trust has found. In many cases symptoms such as fatigue, insomnia, depression, diarrhoea and neuropathy make it hard to work and perform other daily activities, the report of the survey finds.

The survey also found a significant degree of overlap between symptoms; generally, if people had one symptom, more than two-thirds of them were likely to have at least one other. One other finding was that the majority of respondents found that the symptoms were not only fluctuating, but were also completely unpredictable. This made planned activities, both at work and socially, difficult. About 60% of respondents were employed.

This study is a pilot survey of an independent working group brought together to review the Work Capability Assessment (WCA), the medical procedure under which claimants are assessed for Employment and Support Allowance. The WCA had been criticised, especially in an independent review conducted by occupational health expert Professor Malcolm Harrington, for being inflexible and for not being designed to accommodate illnesses characterised by fluctuating symptoms. See www.aidsmap.com/Whats-happening-to-benefits/page/1793223/ for more on the WCA and the Harrington Report.   

Survey results in detail

The NAT study asked people with HIV to complete an online survey about their experience, during the previous six months, of five symptoms commonly associated with HIV: fatigue, anxiety or depression, insomnia, gastro-intestinal problems and neuropathy (nerve pain). There was space to mention other symptoms too.

It is not surprising that in a study inviting people to self-report, the majority of the 265 respondents had at least one of the symptoms on the list. The most common was fatigue, suffered by 57%, followed by depression or anxiety (55%), gastro-intestinal (GI) problems (48%), insomnia (46%) and neuropathy (33%).

More significant was the fact that more people experienced these symptoms as fluctuating rather than constant. Respondents described conditions as ‘constant’ with frequencies ranging from about 38% in insomnia to 24% in the case of GI problems, but as ‘varying over time’ with frequencies ranging from 53% in fatigue to 31% with neuropathy.   

Fatigue was mentioned as a particularly common and troubling symptom. Very few respondents could usually predict when fatigue would hit them. One commented that “When I have it I am quite incapacitated and have no choice but to limit, stop or cancel plans to do things.” Another said “it is always there, lurking...if I do anything for more than an hour it begins to kick in.” One respondent managed to hold down a job but always required a nap of one to two hours immediately after coming home. Although 40% of respondents thought a combination of HIV and HIV medications caused their fatigue, 30% said they really had ‘no idea’ what caused it.

Depression and anxiety were nearly as common as fatigue, though respondents did not say they affected work so much. The main feature of these were their frequency: 90% of respondents said they had experienced either or both at some point in the last month. Given that a third of respondents said that bouts of depression or anxiety lasted more than a week at a time, many people must be living with severely disordered mood a lot of the time.

Diarrhoea, nausea and other GI problems were the symptoms most likely to be linked in people’s minds to HIV treatment. Thirty per cent of respondents thought these were the exclusive cause of their problems and 45% thought HIV and HIV treatments were both to blame. The frequency of bouts of diarrhoea varied from once to more than five times a month.

Insomnia and poor sleep, especially chronic, not only impacts on quality of life: it is a cause of significant physical and psychological illness. Although this has been associated with HIV drugs, especially efavirenz, 45% of respondents did not know why their sleep was so poor. Sleeplessness was very unpredictable – people would be fine one night and not the next. Forty-three per cent said having problems sleeping could last for more than a week. When insomnia is this prolonged, memory, mood and cognitive function can be severely affected. One respondent said sleep problems meant “I am unable to focus on my work, feeling like I have jet lag.”

Neuropathy (nerve pain) was the least-experienced of the conditions but was still suffered by a third of respondents. About equal numbers of people attributed it to HIV itself and to HIV drugs. In some cases the pain of neuropathy was constant – one person said his feet were always sore and this prevented standing or walking for more than 15 minutes. But the majority said that while some symptoms such as numbness were always there others, such as stabbing pains, were unpredictable and often severe.   

Most respondents suffered from multiple symptoms: for instance, of those with depression or anxiety, 75% also had fatigue and 57% insomnia; of those with neuropathy, 61% had fatigue and 68% GI problems.

About 40% of respondents were unemployed, with a higher proportion among those reporting GI problems or fluctuating neuropathy. There was a generally positive attitude to work, with one respondent happy to have just started a job after 18 months of unemployment – “I am knackered but happy to be working,” s/he said.

In other cases however it was clear that fluctuating symptoms were significantly affecting people’s ability or willingness to work. One question asked “on how many occasions in the past four weeks have your symptoms significantly affected your ability to work”? A quarter of people with fatigue, 20% with neuropathy, and about 15% of those with depression and GI problems reported that this had happened more than five times in the past four weeks.

One respondent asked: “How do you work round this kind of thing unless you work for yourself or for an extremely understanding employer?”   

Conclusions and recommendations

NAT concludes that the responses to their survey reveal that fluctuating symptoms are a cause of real morbidity and distress to people living with HIV and place significant barriers to work. They add that the variation and unpredictability of symptoms was often as much of a problem as the symptoms themselves.

Because the symptoms are fluctuating, ESAs may not capture them if the person is having a ‘good day’, but there are other methods of assessment, such as asking people to keep a symptom diary.

NAT recommends that more research needs to be undertaken into these common, fluctuating symptoms and that HIV organisations should raise awareness amongst employers, and with people with HIV themselves, about the importance of making reasonable adjustments at work to enable people with HIV to continue in employment.

In terms of the ESA itself, NAT recommends that ESAs need to take into account “the full range of barriers fluctuating symptoms present to participation in work and other daily activities,” including their unpredictability and the fact that they come in combination.

“Assessment should consider the impact of fluctuation and the cumulative impact of multiple, lower-level symptoms on people living with HIV,” they comment.

 

Taken from Aidsmap, 19 September, 2011

Posted: September 20, 2011 by Nozizwe (updated October 26, 2011)

Coffee consumption reduces side-effects in people on hepatitis C treatment

Drinking three or more cups of coffee a day reduced the incidence of self-reported side-effects by more than 80% compared to non-coffee drinkers in people co-infected with hepatitis C and HIV who were taking hepatitis C treatment, a French study has found.

The study adds to evidence that coffee could be a useful and cheap 'supplement' for people taking hepatitis C treatment and could considerably increase the rate of treatment success. A study published in June (Freedman) found that in patients with hepatitis C and not HIV, drinking three or more cups of coffee a day increased the likelihood of treatment success by 80%.

The HEPAVIH ANRS CO13 study is a cohort study of hepatitis C/HIV co-infected patients taking pegylated interferon/ribavirin hepatitis C therapy. For the present study, 106 patients were evaluated.

Patients were asked whether they drank coffee and, if so, whether they drank it occasionally or had one, two or three or more cups of coffee a day. They were also asked to report on whether they had experienced a list of 30 different symptoms that have been reported as side-effects of hepatitis treatment and to rate the degree of distress they caused.

Seventy-five (71%) of the patients were men, their average age was 44 and 80% had been infected with both hepatitis C and HIV through injecting drugs.

At the start of the study 86% of the patients were taking HIV treatment and had an undetectable HIV viral load, although 13% had a CD4 count below 200 cells/mm3. More than half (52%) of patients had severe liver fibrosis or cirrhosis (fibrosis grades 3-4).

The median number of self-reported treatment side-effects at baseline was three; 31% reported no side-effects and 25% reported over eight.

People drinking three or more cups of coffee a day were 81% less likely to report discomforting side-effects than people reporting none. The likelihood of reporting side-effects decreased by one-third (33%) between each category of coffee consumption (i.e. occasional drinkers had 33% fewer side-effects than non-drinkers, patients drinking one cup a day had 33% fewer than occasional drinkers, and so on).

After adjusting for gender, age and history of opioid use, which are known correlates of reporting a higher number of discomforting side-effects, the effect of coffee remained significant (36% decrease per increase in number of cups drunk).

The researchers comment that the effects seen could be due to caffeine combating the fatigue and lack of concentration and alertness often reported by patients receiving hepatitis C treatment. However It is already known that drinking large amounts of coffee is associated with lower levels of liver enzymes and slower progression of pre-existing liver disease, and previous studies have reported no benefit in drinking tea, which also contains caffeine, albeit at lower levels. The researchers suggest further research into the benefits of coffee consumption and/or caffeine.

 

Taken from Aidsmap, 19 September, 2011

Posted: September 20, 2011 by Nozizwe (updated September 20, 2011)

HIV treatment – new drug does well in people starting treatment

HIV treatment that includes a once-daily dose of the new NNRTI etravirine (Intelence) appears to be safe and effective in people starting antiretroviral therapy.

An NNRTI is a type of antiretroviral drug, commonly used in HIV treatment. It stands for non-nucleoside reverse transcriptase inhibitor.

Etravirine is a powerful NNRTI. It works against most strains of HIV that have resistance to the older NNRTIs – efavirenz and nevirapine (Viramune).

The drug is licensed to be taken twice daily, and is approved for use by people with previous experience of HIV treatment.

But researchers wanted to see if a once-daily dose was safe and effective in people starting antiretroviral therapy for the first time.

Researchers compared etravirine to the widely used NNRTI efavirenz (Sustiva, also in the combination pill Atripla).

Equal proportions of people experienced a sustained fall in their viral load to undetectable levels. But etravirine was less likely to cause the mood and sleep problems often associated with efavirenz.

Their research involved 157 people. They were randomised to receive either etravirine or efavirenz, which was taken in combination with two NRTIs (nucleoside reverse transcriptase inhibitors, another type of antiretroviral drug).

After a year of treatment, 76% of people taking etravirine had an undetectable viral load compared to 75% of those taking efavirenz.

Four of the people taking etravirine had a detectable viral load – in most cases this was below 200 copies/ml, and none developed drug-resistant virus. However, three of the seven people taking efavirenz who had a detectable viral load developed resistance.

Only 6% of patients taking etravirine had mood or sleep problems after a year of therapy compared to 22% of patients treated with efavirenz.

For more information on the different types of anti-HIV drugs and how they work, you may find the section of our website ‘Ways of attacking HIV’ useful

 

Taken from HIV Weekly, 14 September 2011

Posted: September 15, 2011 by Nozizwe (updated October 26, 2011)

Study shows 'remarkable' effectiveness of modern HIV treatment

US investigators have found evidence of the “remarkable” success of antiretroviral therapy in disadvantaged urban minority populations. In the online edition of Clinical Infectious Diseases, researchers from Johns Hopkins’ University, Baltimore, report that in 2010 their patients’ average viral load was below 200 copies/ml.

“This is a remarkable accomplishment that is probably due to improved antiretroviral drugs and changes in management, including the starting of therapy at less advanced immunosuppression,” comment the authors.

They add that the levels of HIV suppression achieved by their patients could have important implications for the prevention of further HIV transmissions.

Triple-drug antiretroviral therapy first became available in 1995-96. However, it was based on unboosted protease inhibitors that lacked potency. Treatment also had other limitations. It often involved unpleasant side-effects, adherence was difficult, and many patients had pre-existing resistance due to a history of previous therapy involving only one or two anti-HIV drugs.

Since then there have been major improvements in HIV treatment and care. These have included the introduction of boosted protease inhibitors and potent NNRTIs, as well as the development of drugs in new classes. Indeed, the goal for HIV treatment for most patients is an undetectable viral load. Moreover, there have also been changes in treatment guidelines, which now recommend the early initiation of antiretroviral therapy.

Johns Hopkins’ HIV clinic serves a large socially disadvantaged urban population. Between 1996 and 1998 only 44% of the clinic’s patients taking HIV therapy achieved an undetectable viral load, but by 2001 to 2002 this had increased to 79%.

Investigators from the clinic wanted to see how changes in HIV treatment and care had impacted on their patients’ viral load between 1996 and 2010.

A total of 5290 individuals were included in the investigators’ analysis.

There were important changes in the demographics and clinical characteristics of the patients over the period of the study.

Their median age increased from 38 years in 1996 to 49 years in 2010. There was also a marked fall in the proportion of patients who were infected with HIV via injecting drug use, from 46% in 1996 to 36% in 2010. At the same time, there was an increase in the percentage of patients who acquired HIV through heterosexual intercourse (43% to 51%).

The proportion of patients taking triple-drug antiretroviral therapy increased from 22% in 1996 to 85% in 2010, and overall CD4 cell count increased from a median of 239 cells/mm3 to 444 cells/mm3.

Median viral load fell from 10,000 copies/ml in 1996 to below 200 copies/ml in 2010. Moreover, by 2010, only 17% of patients had a viral load above 500 copies/ml.

Rates of retention in care improved from 86% in the period 1996 to 2002 to 94% by 2010.

“We believe that our results emphasize that even an inner urban HIV-infected population with a relatively high proportion of patients who were infected as a consequence of injecting drug use, HAART [highly active antiretroviral therapy] can be highly efficacious,” write the authors.

They add: “These results…reflect the increasing use of HAART and are a testament to the remarkable effectiveness of HAART in our patient population.”

There is considerable interest in the use of HIV treatment as prevention, and the investigators believe that the viral suppression achieved by their patients “may…have implications for transmission of HIV in the urban community which the Johns Hopkins HIV clinic draws its patients.”

An editorial accompanying the study is equally enthusiastic about its findings, the author commenting, “the results of the study are highly relevant for clinicians, because they show an extremely high treatment success rates, even in the context of challenging sociodemographic circumstances. Providers faced with potentially difficult cases can be reassured that most of these cases are in patients who will achieve virologic suppression with the effective and well-tolerated regimens now available.”

 

Taken from Aidsmap, 4 September, 2011

Posted: September 5, 2011 by Nozizwe

Consistent relationship between depression and poor adherence to HIV therapy

Depression has a significant impact on adherence to antiretroviral therapy, according to a meta-analysis published in the online edition of the Journal of Acquired Immune Deficiency Syndromes.

The results of 95 studies involving 36,000 patients were examined by investigators, who comment “depression is consistently associated with nonadherence to HIV treatment.”

Depression was associated with poorer adherence in cross-sectional and longitudinal studies, in both resource-rich and resource-poor settings, and in all populations affected by HIV.

“Interventions that target depressive symptoms and optimal utilisation of HAART [highly active antiretroviral therapy] may have maximal effects on health outcomes,” write the authors.

HIV therapy works best if all or nearly all of the recommended doses are taken correctly. However, many patients have difficulty adhering to their therapy, and poorer adherence has been associated with an increased risk of treatment failure.

Missing occasional doses of medication is usually due to simple forgetfulness and is unlikely to have any clinical significance. However, poorer adherence can be related to social circumstances or co-morbid conditions, including mental health problems.

Depression and depressive symptoms are common in patients with HIV, with some studies finding a prevalence of 36%.

Many studies have looked at the relationship between depression and poor adherence to HIV therapy, but until now there has been no meta-analysis of their results, evaluating the strength and consistency of their findings.

Therefore a team of investigators lead by Dr Jeffrey Gonzalez of the Albert Einstein College of Medicine, New York, conducted a literature search to identify studies published since 1996 that examined the impact of depression or depressive symptoms on adherence.

A total of 95 studies involving over 36,000 patients met their inclusion criteria.

Overall, the studies showed a highly significant relationship between depression and non-adherence (p < 0.0001).

The overall effect of depression on adherence was relatively modest (0.19). However, the investigators note that it was of a similar magnitude to that observed in a separate meta-analysis into the effect of depression on adherence in other chronic illnesses.

Studies that measured adherence by interview found a significantly stronger relationship between depression and non-adherence that studies employing self-completed questionnaires (p = 0.03).

Depression was equally likely to affect adherence in cross-sectional and longitudinal studies.

Even mild symptoms of depression were associated with poorer adherence, the investigators commenting, “Our findings also suggest that the relationship between depression and HAART nonadherence is not limited to comparisons between those who meet the criteria for clinical depression and those who do not…studies that focused on depression diagnosis found equivalent effects to studies that measured depression as a degree of symptom severity.”

However, the meta-analysis was not able to show how depression affects adherence.

The researchers speculate that it could be related to its impact on concentration, appetite, self-worth, or self-care.

They conclude, “novel approaches to the successful management of these linked problems could have significant public health benefits for patients living with HIV/AIDS."

 

Taken from Aidsmap, 1 September,2011

Posted: September 5, 2011 by Nozizwe (updated October 26, 2011)

Co-infection with hepatitis delta increases risk of death for patients with HIV

Infection with hepatitis delta virus is associated with an increased risk of death for HIV-positive patients with chronic hepatitis B infection, European research published in the online edition of AIDS shows.

“In our study we reported for the first time that hepatitis delta was…predictive of increased risk of liver-related death and overall mortality in HIV patients,” write the investigators, who recommend that all HIV-positive patients with chronic hepatitis B infection should be tested for the infection.

Hepatitis delta (HDV) is the most aggressive form of chronic hepatitis infection in humans. Worldwide, between 15 and 20 million individuals carry the virus, including 5% of patients with chronic hepatitis B virus infection (HBV).

HIV, hepatitis B, and hepatitis delta all share modes of transmission, including sex transmission, injecting drug use and from a mother to her baby.

However, little information is available on the prevalence of the infection in patients with HIV. Nor are its epidemiology, viral characteristics, and natural history well understood.

To answer these questions investigators from the EuroSIDA cohort examined the medical records of HIV-positive patients with chronic hepatitis B (hepatitis B surface antigen positive [HBsAg+]).

Their analysis included 422 patients and 61 (15%) had antibodies to hepatitis delta.

Prevalence of the infection was significantly higher in patients with a history of injecting drug use (42%) compared to patients whose HIV risk factor was heterosexual intercourse (9%) or sex between men (3%) (p < 0.001).

Hepatitis delta co-infection was more common in Southern (21%) and Eastern Europe (9%) than in Northern (9%) or Central Europe (11%) (p = 0.003).

Most of the hepatitis delta-infected patients were white (84%) and two-thirds were receiving antiretroviral therapy. Median CD4 cell count was 281 cells/mm3 and median HIV viral load was undetectable.

The investigators’ first set of analyses showed that co-infection with hepatitis delta was significantly associated with younger age (p = 0.0007), female sex (p = 0.005), intravenous drug use (p < 0.0001), co-infection with hepatitis C virus (p < 0.0001), residence in Southern or Eastern Europe (p < 0.003), and infection with hepatitis B sub-type D (p < 0.01).

However, only injecting drug use (p = 0.0003) remained significant in analysis that controlled for confounding factors.

Hepatitis B genotype D was detected in 50% of patients infected with hepatitis delta compared to 12% of individuals negative for the infection.

The investigators were able to detect hepatitis delta viral load in 31 patients, and median viral load was 1.76 x 107 copies/ml.

The only hepatitis B subtype found in patients with a hepatitis delta viral load above this level was subtype D.

Earlier research has shown that, with the exception of patients with hepatitis B subtype D, co-infection with hepatitis delta is associated with an attenuation of hepatitis B virus infection. The present study confirmed these findings. Overall, co-infected patients had lower median hepatitis B viral loads than patients not infected with hepatitis delta (p = 0.003). However, the exception was patients with hepatitis B genotype D.

“Hypothetically, this last group of patients replicating both HBV and HDV might experience enhanced liver damage,” suggest the investigators.

Co-infection with hepatitis delta was associated with an increased risk of death (p = 0.01) and of death from end-stage liver disease (p = 0.008).

Treatment for hepatitis delta is “challenging” and usually consists of twelve months of therapy with pegylated interferon-alpha. There is also some evidence that tenofovir, 3TC and adefovir are active against the virus.

“Most guidelines recommend that HBsAg+ patients should be tested for anti-HDV antibodies,” note the authors, “failure to exclude HDV infection in HBsAg carriers may result in an unexpected worse outcome and trigger unnecessary search for other etiologies of liver disease.”

 

Taken from Aidsmap, 5 September, 2011

Posted: September 5, 2011 by Nozizwe

September - Sickle Cell Disorder Awareness month

The disorder affects the red blood cells which contain a special protein called haemoglobin (Hb for short). The function of haemoglobin is to carry oxygen from the lungs to all parts of the body.

People with Sickle Cell Anaemia have Sickle haemoglobin (HbS) which is different from the normal haemoglobin (HbA). When sickle haemoglobin gives up its oxygen to the tissues, it sticks together to form long rods inside the red blood cells making these cells rigid and sickle-shaped. Normal red blood cells can bend and flex easily.

Who Gets Sickle Cell Disorder (SCD)?

The different kinds of SCD and the different traits are found mainly in people whose families come from Africa, the Caribbean, the Eastern Mediterranean, Middle East and Asia.* In Britain SCD is most common in people of African and Caribbean descent (at least 1 in 10-40 have sickle cell trait and 1 in 60-200 have SCD). It is estimated there are over 6,000 adults and children with SCD in Britain at present. There are other inherited conditions that mainly affect other groups, e.g. Cystic Fibrosis in Europeans, and Tay-Sachs disease in Jewish people.

This information was taken from http://www.sicklecellsociety.org/

The NHS has details of Sickle Cell Disorders here

We are not responsible for content of external web sites and only offer links to other sites as an alternative source of information.

Posted: September 2, 2011 by Pete (updated October 26, 2011)

TB – development after starting HIV treatment

Tuberculosis (TB) is the single most important cause of illness and death in people with HIV.

Even in richer countries such as the UK and US it is one of the most common AIDS-defining illnesses.

People who are not taking HIV treatment should be regularly screened for TB and checked for symptoms.

Antiretroviral therapy allows the immune system to strengthen and this provides protection against TB and other infections.

US researchers have now pinpointed the risk factors for TB in people who are being treated with anti-HIV drugs.

They examined the medical records of approximately 38,000 people. TB developed in 0.4% of these individuals.

A CD4 cell count below 200, a history of injecting drug use, and non-white race were all associated with TB.

The researchers hope their findings will encourage the screening of those at highest risk.

For more information on TB, visit our Tuberculosis and HIV topics pages, which bring together our TB resources, features, news and news from other sources.

 

Taken from HIV Weekly, 31 August, 2011

Posted: September 1, 2011 by Nozizwe (updated October 26, 2011)

NRTI-sparing combination of darunavir/ritonavir and raltegravir not a good option for people with high viral load

An HIV treatment combination comprising ritonavir-boosted darunavir and raltegravir has “acceptable” virological efficacy, but may be a poor option for patients with a high viral load, US investigators report in the online edition of AIDS.

Resistance to raltegravir emerged in some patients with low levels of detectable virus, “an important observation”, write the investigators, “since recent guidelines state that VL [viral load] > 200 copies/ml can be considered the threshold for VF in clinical practice.”

Since 1996 antiretroviral therapy has been based on a “backbone” of two nucleoside reverse transcriptase inhibitors (NRTIs). However, many of the side-effects of HIV therapy are associated with NRTI.

Two drugs may be enough to achieve durable suppression of HIV, and a combination consisting of the ritonavir-boosted protease inhibitor darunavir (Prezista) and the integrase inhibitor raltegravir (Isentress) is being investigated in clinical trials.

One of these is the US ACTG A5262 study. It recruited 112 HIV-positive individuals who were starting antiretroviral therapy for the first time.

They were treated with an open-label regimen of ritonavir-darunavir 800/100mg once daily a twice-daily dose of 400mg of raltegravir.

The primary endpoint of the study was the proportion of patients with virological failure at or before week 24.

This was defined as a viral load of 1000 copies/ml or above at week twelve; a 0.5 log10 increase in viral load between weeks four or twelve; or a viral load above 50 copies/ml at week 24. On the basis of earlier research, a failure rate of 35% at week 24 was considered acceptable.

Secondary endpoints included the proportion of patients with viral suppression at week 48; the emergence of resistance; changes in CD4 cell count; and safety.

Most (88%) of the patients were men and their median age was 36 years.

Baseline median CD4 cell count was 271 cells/mm3 and median viral load at the start of therapy was 4.87 log10 copies/ml. Many patients had a high pre-treatment viral load, including 44% with a viral load above 100,000 copies/ml and 5% with a viral load above 750,000 copies/ml.

The overall rate of virological failure at week 24 was 16% (n = 17).  By week 48 the failure rate had increased to 26% (n = 28).

In an intent-to-treat analysis that included all patients enrolled in the study regardless of withdrawal or treatment modification, 74% of patients had an undetectable viral load at week 24 and 61% at week 48.

Patients experiencing virological failure had a higher baseline viral load than individuals with virological suppression (median 5.22 log10 copies/ml vs. 4.70 log10 copies/ml; p = 0.002). They also had a lower median CD4 cell count at the start of therapy (192 vs. 322 cells/mm3; p = 0.007).

Of the 28 patients with virological failure, 21 had a baseline viral load above 100,000 copies/ml.

Statistical analysis adjusting for age and sex showed that virological failure was associated with a baseline viral load above 100,000 copies/ml (hazard ratio [HR] = 3.76; 95% CI, 1.52-9.31; p = 0.004). CD4 cell count was also significant,  and each 100 cell/mm3 increase in baseline count reduced the risk of virological failure by 33% (HR = 0.77, 95% CI, 0.61-0.98; p = 0.037).

A viral load above 100,000 copies/ml remained a significant predictor of treatment failure when trough concentrations of raltegravir were also included in the analysis (p < 0.001). Moreover, having undetectable plasma levels of raltegravir on at least one occasion was also associated with failure to suppress viral load (p = 0.006).

A total of five patients developed resistance to raltegravir. Their viral load ranged from 62 to 685 copies/ml, indicating that “raltegravir resistance mutations may be present at low level viremia.”

CD4 cell counts had increased by a median of 142 cells/mm3 at week 24 and 200 cells/mm3 at week 48. Patients with a baseline viral load below 100,000 copies/ml had more robust increases in CD4 cell count at week 48 than patients with higher viral loads (233 vs. 180 cells/mm3; p = 0.044).

The combination appeared safe. Approximately a fifth of patients developed a grade 3 or higher clinical or laboratory event. Only one patient stopped treatment because of side-effects, a rash and stomach pains.

The investigators conclude their results “raise important issues that should be examined carefully in future studies evaluating darunavir/ritonavir plus raltegravir and perhaps in all NRTI-sparing two-drug regimens.”

They urge caution in patients with baseline VL > 100,000 copies/ml and emphasise "a need to further elucidate the implications of low-level viremia in patients receiving this regimen.”

 

Taken from HIV Weekly, 31 August, 2011

Posted: September 1, 2011 by Nozizwe (updated October 26, 2011)

HIV and the criminal law

The criminalisation of HIV transmission is causing anger, fear and confusion in people with HIV, and is a barrier to honest discussions with healthcare providers, new research shows.

The research was conducted in Canada, a country which has prosecuted and imprisoned people for not disclosing their status before having unprotected sex.

The law on HIV exposure and transmission in Canada is confusing and inconsistently applied – some people have been tried and/or convicted for having sex with a condom or having oral sex.

Researchers wanted to see what impact this was having on both people with HIV and their service providers.

They found that it was causing a lot of fear and uncertainty and service providers reported that it was hampering honest discussions about sexual risk-taking and sexual health.

The researchers call for the development of proper guidelines for prosecutors.

Such guidelines already exist in the UK, where they also cover other sexually transmitted infections.

Last week a man was sent to prison for 14 months (see news report in Northampton Chronicle & Echo) for passing on genital herpes to his girlfriend. He knew he had the infection, but thought it had gone away.

The man pleaded guilty. Transmission would have been very difficult to prove and the sentence has been widely condemned by sexual health doctors and lawyers who specialise in this area (see comment in the Guardian).

It’s very important to get expert advice as soon as possible if you become involved in a police investigation into the transmission of HIV or any other infection. In the UK, the Terrence Higgins Trust helpline, THT Direct, can put you in touch with experts in this field who can provide information, advice and support.

For more information on HIV and criminal law, visit www.aidsmap.com/law.

 

Taken from HIV Weekly, 24 August 2011

Posted: August 24, 2011 by Nozizwe (updated October 26, 2011)

Poor outcomes in 17 to 24 year olds using adult HIV services

American research published in the online edition of the Journal of Acquired Immune Deficiency Syndromes has highlighted the importance of providing  appropriate support to HIV-positive adolescents and young adults as they begin to use adult HIV clinics.

Investigators from Chicago found that HIV-positive individuals aged 17 to 24 were less likely than older HIV-positive adults to achieve and maintain an undetectable viral load. Moreover, adolescents and young adults were significantly more likely to be lost to follow-up.

Especially poor outcomes were seen in African Americans adolescents and young adults.

“We found inferior virologic outcomes and higher loss to follow-up among HIV-infected AYA [adolescents and young adults] compared to matched HIV-infected adults,” comment the investigators. They also note “African American AYA had the lowest rates of viral suppression and the highest rates of viral rebound.”

Thanks to antiretroviral therapy, many children who were infected with HIV at birth are now reaching adulthood.

HIV care for children is usually provided in specialist paediatric clinics, but in adolescence or early adulthood care is transferred to adult HIV services.

Moreover, there are significant numbers of new HIV infections in teenagers and individuals in their early 20s.

Little is known about the outcomes of adolescents and young adults who are cared for in adults-oriented HIV clinics. Therefore, investigators at Chicago’s Northwestern Memorial Hospital designed a retrospective study including 46 patients aged 17 to 24 who were matched on a one-to-one basis with patients aged between 25 and 40.

The investigators compared the proportion of patients in each age group who had an undetectable viral load six months after starting HIV therapy or if they were already taking antiretroviral drugs, the commencement of their care at the clinic. Rates of rebound in viral load and loss to follow-up were also compared.

The study included individuals who received care between 2003 and 2009.

Adolescents and young adults were less likely than older adults to have an undetectable viral after six months (59% vs. 78%, p = 0.025).

Pregnant younger patients also had poor rates of virological suppression after six-months than adult patients who were pregnant (56% vs. 85%, p 0.04).

In addition, viral load rebound was more frequent in adolescents and young adults than in older adults (56% vs. 13%, p = 0.002).

Almost half (44%) of those aged 17 to 24 were lost to follow-up compared to only 11% of older adults, a highly significant difference (p = 0.001).

Especially poor outcomes were seen in young African American patients.

Only 44% of this patient group had virological suppression after six months, compared to 71% of African American adults, 77% of non-African American adolescents and young adults, and 91% of non-African American adults.

High rates of viral load rebound were also seen in young African American patients (77% vs. 42% non-African American 17 to 24 year olds vs. 18% African American adults vs. 6% non-African American adults).

However, there were no significant differences in rates of six-month virologic control between the seven younger patients infected with HIV at birth and the 17 to 24 year olds infected with HIV through other means (57% vs. 59%).

The investigators suggest that “several factors render adolescents and young adults at higher risk of poor clinical outcomes,” including development issues, socioeconomic stresses, and HIV-related stigma.

Moreover, the investigators note “adolescents often experience feelings of invulnerability which can increase their risk of HIV acquisition, reduce rates of testing, and reinforce negative health care behaviors after diagnosis.”

A number of limitations are acknowledged by the investigators, including the study’s retrospective design and small sample size.

They also emphasise “our AYA clinic population included only a small group with perinatally-acquired HIV infection, a complex patient population whose outcomes may differ from behaviorally-infected AYA though this was not demonstrated in our study.”

Nevertheless, the researchers believe their findings have implications for the care provided to adolescents and young adults who are using adult HIV services.

They conclude, “these patients will benefit from careful study and additional resources directed to improve outcomes. Potential strategies to improve outcomes may include improved social support, provider training, and systems-based quality improvements.”

 

Taken from Aidsmap News, 22 August,2011

Posted: August 22, 2011 by Nozizwe (updated October 26, 2011)

Pre-term delivery in mothers receiving HIV treatment: more research needed befor

HIV-infected pregnant women on a protease-inhibitor (PI) triple antiretroviral regimen were twice as likely to have a preterm delivery compared to those on a triple nucleoside reverse transcriptase inhibitor (NRTI) regimen, Kathleen M. Powis and colleagues reported in a secondary analysis from a randomised clinical trial (the MmaBana study) in Botswana published in the August 15 edition of the Journal of Infectious Diseases.

But in an accompanying editorial Athena P. Kourtis and Mary Glenn Fowler caution that further research is needed before making recommendations about ART during pregnancy as a consequence of the risk of pre-term delivery attached to any regimen.

Antiretroviral therapy in HIV-infected women during pregnancy and breastfeeding for their own health and for the prevention of HIV transmission to their infants is recognised as a highly effective public health strategy.

The parent study from which this analysis is taken demonstrated that both a PI-based regimen and NRTI-based regimen started late in pregnancy (26-34 weeks into the pregnancy) were highly efficacious in reducing maternal viral load at delivery and transmission rates to the infant.

However, the link between a PI-based regimen and the risks of preterm delivery (before 37 weeks of pregnancy) continues to be controversial. Some observational studies have suggested a link, while others have not.

These studies have been primarily in resource-rich settings. In resource-poor settings any increase in preterm delivery can have an adverse effect on infant survival. Identifying risk factors for preterm delivery and determining the contributing role of PI-based regimens is essential for the development of guidelines.

The authors looked at risk factors for preterm delivery in a cohort of HIV-infected pregnant women with CD4 cell counts under 200 cells/mm3 randomised to get either PI-based regimen (lopinavir/ritonavir/zidovudine/lamivudine) or NRTI-based regimen (abacavir/zidovudine/lamivudine) at 26-34 weeks of pregnancy in a clinical trial to prevent mother-to-child transmission (MmaBana).

They also looked at maternal weight gain in late pregnancy and infant disease and death rates up to six months of age. Poor weight gain is known to be a risk factor for preterm delivery. PI-based regimens are known to cause gastrointestinal problems and adverse metabolic effects. Maternal change in body mass index (BMI) one month after the start of ART was compared according to treatment arm and delivery (preterm compared to term).

Among women (267) in the PI arm preterm delivery rates were higher than among the 263 women in the NRTI arm, 21.4% compared to 11.8%, p=.003. The PI-based regimen was the most significant risk factor, (OR: 2.03, 95% CI: 1.26-3.27, p=0.004).

While median change in body weight in those in the PI arm was lower than in the NRTI arm one month after starting ART, there was no significant association with preterm delivery.

Serious infant illness, defined as hospitalisation and death up to six months of age, did not differ by maternal regimen. Kourtis and Fowler suggest that this is probably because most preterm deliveries would have been near term, adding that this would have been useful data to include.

While acknowledging the importance of this first randomised controlled trial to show a difference between ART and the risk of preterm delivery, Kourtis and Fowler caution that the issue is not simple. The study, they add, has the potential to raise more questions than answers.

They note, as do the authors, that the MmaBana study was not powered to answer the question of preterm delivery. As such the sample size may not be adequate. In Botswana the preterm delivery rate in the general population is 20%. As a consequence, Kourtis and Fowler note that to validate an increase in the risk of preterm delivery to the degree seen in the PI arm would require a much larger sample size.

Kourtis and Fowler also highlight the unexplained finding of the considerable lower rate of preterm delivery in the NRTI arm.

Noting the high number of twin deliveries in the NRTI arm compared to the PI arm, Kourtis and Fowler state that while the differences cannot be linked to the type of ART regimen “this serves as a reminder that chance differences can be present even in randomly allocated groups.”

Kourtis and Fowler question whether late start of ART could be linked to preterm delivery: approximately one third of those who delivered preterm had had ART for less than thirty days. The highest rate of preterm delivery was seen in those who started ART later regardless of treatment arm.

They suggest that data from the same setting comprising women with similar baseline CD4 cell counts but who had been on a simplified prophylactic regimen, for example, zidovudine and/or single-dose nevirapine, would be helpful for comparison.

They further question the timing of enrolment that limits the ability to look at very preterm deliveries (less than 32 weeks of pregnancy), which are associated with more severe infant outcomes.

Kourtis and Fowler note that several randomised studies have suggested there may be a link between PI use and preterm delivery. However, they cite the Kesho Bora study as the only other study that “sheds light on the issue.” Over 800 women in Burkina Faso, Kenya and South Africa with CD4 cell counts between 200 and 500 cells/mm3 were randomised to a PI triple ART regimen orzidovudine and single dose nevirapine. ARVs were started between 28 and 36 weeks of pregnancy, except for single-dose nevirapine. No difference was seen in the preterm delivery rates.

Kourtis and Fowler stress the relevance and rigour of the findings in a field where more information is needed.

PI-based ART regimens are a critical component of PMTCT and treatment programmes with proven benefits for maternal and child health.

Kourtis and Fowler conclude further studies and careful consideration of the questions raised are needed before recommendations can be made regarding ARVs for PMTCT and the risk of preterm delivery.

 

Taken from Aidsmap News, 22 August 2011

Posted: August 22, 2011 by Nozizwe (updated October 26, 2011)

Treatment during pregnancy

New research found that women who took a protease inhibitor during pregnancy were twice as likely to have a premature baby compared to women who took an NNRTI.

There’s been a lot of debate protease inhibitors and the risk of pre-term delivery. Some studies have found an association, but others have not.

The latest research was conducted in Botswana. Just over a fifth of women treated with a protease inhibitor had a pre-term delivery (before week 37 of pregnancy), compared to 11% of women taking an NNRTI.

Both types of regimen were found to be very effective in reducing mother-to-child transmission of HIV. The researchers note that their study is not definitive and only had a small sample size. Other researchers, commenting on the study, suggest the results could have been influenced by a number of factors – for example, the point at which HIV treatment was started during the participants’ pregnancy (most pre-term deliveries were in women who started treatment later in pregnancy).

They call for further research and careful consideration of the issues raised by the study before any recommendations are made about HIV treatment during pregnancy.

 

Taken from HIV Weekly, 17 August 2011

Posted: August 18, 2011 by Nozizwe

Other conditions – high blood pressure

 

The importance of screening for other conditions was reinforced by the findings of a separate study. It showed that 15% of patients with HIV have high blood pressure.

Patients with HIV should have their blood pressure monitored regularly as part of routine clinic visits.

Researchers in Spain found that, when monitored in this way, 21% of their patients had high blood pressure (hypertension).

However, because patients are often anxious when seeing their doctor, their blood pressure can be temporarily higher than it is normally. Therefore, all patients with high blood pressure were referred for 24 hour monitoring.

A total of 39% of patients undergoing this monitoring outside the clinic were found to have normal blood pressure.

The researchers therefore calculated that the true prevalence of high blood pressure in their patients was 15%.

Risk factors for high blood pressure include older age and a family history of hypertension. The number of previous HIV treatment combinations was also a factor. The researchers believe this could be “an indirect measurement of antiretroviral treatment duration and cumulative drug-related toxicity”.

 

Taken from HIV Weekly, 17 August 2011

Posted: August 18, 2011 by Nozizwe

Prognosis – treatment with statins

Treatment with statins has been shown to reduce the risk of death for people taking HIV treatment.

Statins are best known as a treatment for high cholesterol. But they also have an anti-inflammatory effect.

Many of the diseases that cause serious illness and death in patients with HIV, for example cardiovascular disease, are linked to inflammation. Researchers at the HIV clinic at Johns Hopkins University in Baltimore wanted to see if taking statins could reduce the risks associated with this inflammation.

All 1538 patients in the study were doing well on HIV treatment and had an undetectable viral load.

A total of 16% of the participants were taking statins, and these people were found to have a significantly reduced risk of death during the study period compared to the patients who were not on statin therapy.

Treatment with statins was shown to reduce the risk of death by 67%.The reduction in risk was not due to the effect of the statins on heart disease; deaths due to a range of conditions were lower in the patients treated with statins.

The researchers are calling for more studies to examine the potential benefits of statin treatment for people with HIV

 

Taken from HIV Weekly, 17 August 2011

Posted: August 18, 2011 by Nozizwe (updated October 26, 2011)

HIV treatment – new drug

The US Food and Drug Administration has approved Complera, a combination pill containing three drugs, including the new non-nucleoside reverse transcriptase inhibitor rilpivirine.

Complera combines tenofovir and emtricitabine (FTC) (also available as the combination pill Truvada) with rilpivirine (recently approved in the United States as Edurant). Complera is taken once daily, and is suitable only for patients who have not taken HIV drugs before.

Complera is marketed by Gilead Sciences, but is a joint venture with Johnson & Johnson, which developed rilpivirine. Gilead already markets another once-daily three drug combination, Atripla, which is currently the most commonly prescribed first-line HIV treatment. However, according to Reuters, Gilead will earn more from Complera due to a royalties deal which allows it to retain 30% of the royalty it would otherwise pay to Johnson & Johnson.

Marketing approval in Europe is likely to follow by the first quarter of 2012.

Other recent approvals

Boehringer-Ingelheim received a recommendation for approval of the once-daily, delayed release version of nevirapine (Viramune) from the European Medicines Agency in late July, while Merck received European Union marketing approval for its hepatitis C protease inhibitor boceprevir (Victrelis) earlier this month

 

Taken from HIV Weekly, 17 August 2011

Posted: August 18, 2011 by Nozizwe (updated October 26, 2011)

August - Psoriasis Awareness Month

Psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. The condition is not infectious and most people are affected only in small patches on their body.

It affects around 2% of people in the UK. It can start at any age, but most often develops between the ages of 11 and 45.

Most cases of psoriasis go through cycles, causing problems for a few weeks or months then easing or stopping.There are several different types of psoriasis. Normally, people have only one form of psoriasis at a time, although two different types can occur together. One type may change to another type or may become more severe.

Common types of psoriasis are:

• Plaque psoriasis. This is the most common form, accounting for 80% of cases. Its symptoms are dry, red skin lesions, known as plaques, that are covered in silver scales.
• Guttate psoriasis. This normally occurs following a streptococcal throat infection and is more common among children and teenagers.
• Scalp psoriasis. This can occur on parts of your scalp or on the whole scalp. It causes red patches of skin covered in thick silvery-white scales.
• Nail psoriasis. This affects your nails, causing them to develop tiny dents or pits, become discoloured and grow abnormally. 
• Inverse (flexural) psoriasis. This affects areas of the skin that are in folds or creases, such as the armpits, groin and the skin between the buttocks and under the breasts.  

A dermatologist explains how this skin condition is recognised and treated and the challenging effects it can have on an individual.

More information about Psoriasis can be found here at NHS Choices web site. The infomration covers details of symptoms, causes, diagnosis, treatment and living with the condition.

We are not responsible for content of external web sites and only offer links to other sites as an alternative source of information.

Posted: August 11, 2011 by Pete (updated September 28, 2011)

Cardiovascular disease

Patients with HIV have accelerated hardening of the arteries compared with individuals in the general population, according to new research.

But the study also showed that traditional factors for this early warning sign of cardiovascular disease were the biggest risks. These factors include high blood pressure and lipid levels (cholesterol).

It’s now well established that people with HIV have an increased risk of diseases such as heart attack and stroke. The causes are less clear. However, they seem to include the damage caused by untreated HIV, traditional risk factors for these conditions, and possibly the side-effects of some anti-HIV drugs.

Monitoring the hardening of the carotid artery in the neck and the coronary artery can help predict someone’s risk of cardiovascular disease.

Researchers found that people with HIV experienced faster thickening of these arteries than would be expected for individuals of their age.

But the research showed that the most important predictors of hardening of the arteries were risk factors such as blood pressure, insulin and glucose levels, and lipid levels. These are exactly the same factors associated with an increased risk of cardiovascular disease in the general population.

The researchers note: “Aggressive CV [cardiovascular] risk reduction with lipid-lowering and hypertensive medications appears to be effective at slowing the progression of atherosclerosis [hardening of the arteries] in HIV-infected patients.”

Good HIV care should include careful discussion of risk factors for heart disease before starting treatment, advice on risk reduction, and regular monitoring of lipid levels, blood pressure and blood glucose. Regular exercise and stopping smoking can reduce everyone's risk of heart disease.

 

 

Taken from HIV Weekly, 10 August 2011

Posted: August 10, 2011 by Nozizwe

HIV treatment – changes to CD4 cell counts

New research has shown that subtle genetic variations affect CD4 cell changes in black people taking HIV treatment.

Most patients experience a gradual increase in their CD4 cell count after starting HIV treatment. The suppression of viral load to undetectable levels allows the immune system to recover and CD4 cell count to rise, often to levels seen in HIV-negative people.

But this isn’t always the case. Despite having an undetectable viral load, some patients see only modest increases in their CD4 cell counts, and in some cases their CD4 cell count stays so low they remain vulnerable to serious infections and illnesses.

US researchers wanted to try and find possible causes. They noted that earlier research had shown that there were associations between a person’s genetic profile and changes in their CD4 cell count after starting HIV therapy.

Their study sample included approximately 425 people who were starting HIV treatment for the first time. All achieved an undetectable viral load, and changes in CD4 cell count were monitored one and two years after initiating therapy.

At the start of the study, the investigators examined the structure of the patients’ mitochondrial DNA. Mitochondria carry energy in cells, and the severe side-effects caused by some older anti-HIV drugs were connected to the damage they caused to mitochondria.

Overall, the patients had a good increase in their CD4 cell count – after one year of treatment it had increased by an average of 176, and the average two-year increase was 270 cells.

But they found that a number of genetic mutations in mitochondrial DNA were associated with lower CD4 cell increases.

The presence of a cluster of these mutations in black people was associated with lower overall CD4 cell increases.

However, the researchers note that their study was quite small and believe this question needs to be looked at in more detail through other studies.

 

Taken from HIV Weekly, 10 August 2011

Posted: August 10, 2011 by Nozizwe (updated October 26, 2011)

Poor CD4 cell recovery after starting HIV treatment should be a cause for concer

Patients whose CD4 cell count does not recover despite achieving virologic control with HIV therapy require continued medical attention, results of a large European study presented to the recent International AIDS Society conference in Rome show.

Researchers found that individuals whose CD4 count failed to increase above 200 cells/mm3 were significantly more likely to experience a new AIDS-defining event or die than patients with more robust CD4 cell count increases.

“In virologically suppressed patients, lack of increase in CD4 cell count is relevant for prognosis and poorer outcome,” comment the investigators.

Encouragingly, the research also suggested that patients whose CD4 cell count increases to above 500 cells/mm3 have an excellent long-term prognosis.

Modern HIV therapy is potent, easy to take and generally causes only mild side-effects. The goal of treatment is suppression of viral load below 50 copies/ml, and over 90% of patients can achieve this outcome within a year of starting antiretroviral treatment.

In most patients, suppression of viral load is accompanied by a gradual increase in CD4 cell count. Long-term HIV therapy can result in the restoration of CD4 cell count to normal levels.

However, despite having a successful virologic response to treatment, CD4 cell count fails to increase in some patients.

Investigators from the Collaboration of Observational HIV Epidemiology in Europe (COHERE) wished to determine the prognostic implications of poorer CD4 cell increases in patients whose viral load was suppressed.

A total of 66,147 individuals were included in their research. All experienced a fall in their viral load to undetectable levels after starting antiretroviral therapy. Their average age was 37 years, 73% were men, 26% had a prior AIDS diagnosis and 14% had a history of injecting drug use.

Median CD4 cell count at the time HIV therapy was started was high – 396 cells/mm3, and the patients had a baseline viral load of 4.6 log10 copies/ml.

When viral load was first suppressed below 50 copies/ml, 34% of patients had a CD4 cell count above 500 cells/mm3, 25% had a count between 350 and 500 cells/mm3, 26% a count of between 200 and 350 cells/mm3, and 16% had a CD4 cell count below 200 cells/mm3, including 1% with a count beneath the dangerously low level of 50 cells/mm3 – a factor well known to be associated with a poor prognosis.

There were few new AIDS events or deaths among patients whose CD4 cell count was above 500 cells/mm3 (5 per 1000 patient-years).

Events were also rare for patients in the 350 to 500 cells/mm3 and 200 to 350 cells/mm3 strata (7.9 and 12.0 per 1000 patient-years respectively).

However, incidence was markedly higher for patients with a CD4 cell count below 200 cells/mm3 (30.5 per 1000 patient-years), especially so for those with a CD4 cell count beneath 50 cells/mm3 (94.9 per 1000 patient-years).

The investigators plotted the impact of CD4 cell count on long-term outcomes.

The prognosis for patients with virologic suppression and a CD4 cell count above 500 cells/mm3 was excellent. The investigators calculated that they had a 95% probability of survival and avoidance of AIDS.

Projected outcome for patients with a well-controlled viral load and CD4 cell counts between 500-350 or 200-350 cells/mm3 were also good, with event-free survival projected for approximately 90%.

However, at lower CD4 cell counts the chance of remaining alive and AIDS-free were significantly poorer. The projected event-free survival rate for patients with a CD4 cell count beneath 200 cells/mm3 was in the region of 65%.

There was also robust evidence that the time to an event was significantly shorter for patients whose CD4 cell count did not increase above 200 cells/mm3 despite virological suppression (HR = 0.21, 95% CI, 0.19-0.24 vs. HR = 0.92, 95% 0.90-0.94 for patients with a CD4 cell count above 200 cells/mm3).

“In virologically suppressed patients an increase in CD4 cells reduces the risk of AIDS or death,” comment the investigators, “lack of increase in CD4 cell is relevant for prognosis and poorer outcome.”

 

Taken from Aidsmap, 8 August 2011

Posted: August 9, 2011 by Nozizwe

Low but detectable viral load during HIV treatment involves a risk of resistance

Drug resistance frequently develops in patients who have a persistent low detectable viral load when taking HIV therapy, US investigators report in the August 15th edition of the Journal of Infectious Diseases. Treatment guidelines which set the bar for virological failure at 200 copies/ml could mean that patients are not being switched soon enough, the authors argue.

Resistance developed in 37% of patients who had a viral load measurement between 50 copies/ml and 1000 copies/ml on two occasions after six months of HIV treatment.

New resistance mutations were detected in over a third of patients who had a maximum viral load below 200 copies/ml. The investigators believe this is “an important observation considering recent guidelines that virological failure in clinical practice can be defined as VL [viral load] > 200 copies/ml.”

The aim of HIV therapy is persistent suppression of viral load below 50 copies/ml. Even low levels of detectable virus have been associated with higher levels of immune activation, the virological failure of treatment, and an increased  risk of poorer clinical outcomes, including illness and death.

Tests for resistance to antiretroviral drugs do not perform well at low viral loads, and few studies have looked at resistance in the context of low-level viraemia in patients taking first-line HIV therapy.

Therefore a research team led by Dr Banefami Taiwo undertook a study to describe new resistance mutations in patients taking their first combination of anti-HIV drugs who had low but detectable viral load. They also conducted a series of analyses to see if any risk factors predicted the emergence of new resistance mutations.

Their study sample included 1158 antiretroviral-naive patients enrolled in the ACTG A5142 and A5095 studies. These studies examined the safety and efficacy of triple-drug antiretroviral therapy that included either the protease inhibitor lopinavir/ritonavir (Kaletra) or the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva).

Low-level viraemia was defined as two viral load measurements between 50 and 1000 copies/ml after six months of therapy.

Patients who had a low level viral load during therapy were monitored for the emergence of new reverse transcriptase or protease resistance.

Overall, 6% of patients experienced low level viraemia. These patients had a median pre-treatment viral load of 5.1 log10 copies/ml and a baseline CD4 cell count of 121 cells/mm3.

The median time from the initiation of therapy and the appearance of low levels of virus was 39 weeks, and low-level viraemia persisted for a median of 30 weeks.

Over two-thirds (68%) of patients with a viral load between 50 and 1000 copies/ml subsequently resuppressed their HIV to undetectable levels on at least one occasion.

Patients taking an antiretroviral regimen comprising nucleoside reverse transcriptase inhibitors (NRTIs) plus Kaletra were almost three-times more likely to experience low-level viraemia than patients treated with two NRTIs and efavirenz (HR = 2.7; 95% CI, 1.4-5.0).

A pre-treatment viral load above 6 log10 copies/ml was associated with a doubling in the risk of having a low detectable viral load (HR = 2.2; 95% CI, 1.0-4.6). In addition, each 50 cell/mm3 reduction in CD4 cell count increased the risk of low level viraemia by approximately 10%.

Resistance data were available for 56 patients with low viraemia. New resistance mutations during follow-up were detected in 20 (37%) of these individuals.

In all but one of these patients, the new mutation conferred resistance to reverse transcriptase inhibitors. The most common resistance mutations were M1841/V, K103N, and M230L.

The remaining individual developed the D30D/N mutation which confers resistance to the protease inhibitor nelfinavir (Viracept). This leading the investigators to speculate that this may have been a case of transmitted resistance.

The level of viral load during low-levelviraemia was the main risk factor for the development of resistance mutations.

“Patients in whom new mutations were detected tended to have a higher VL at the start of low-level viraemia (p = 0.03) and higher minimum (p < 0.001), maximum (p < 0.001), and mean VL during low-level viraemia (p < 0.001),” observe the authors.

No new resistance mutations were detected in patients whose maximum viral load was between 50 and 100 copies/ml. However, resistance developed in 38% of patients whose viral load was in the region of 100-200 copies/ml.

A larger proportion of patients who developed resistance were black (65% with vs 24% of those without). But the authors are cautious about attaching too much significance to this finding “because of the small number of events and the confounding effect of VL.” They add “if confirmed, possible explanations could include differential adherence or race-based genetic factors that may influence drug metabolism and plasma concentrations.”

The investigators conclude “techniques for detecting resistance during low-level viraemia should be validated for clinical use, and the clinical consequences of low-level viraemia and mutations detected during low-level viraemia should be investigated further".

Taken from Aidsmap, 8 July 2011

Posted: August 9, 2011 by Nozizwe

Pregnancy doubled risk of female-to-male HIV transmission in Partners in Prevent

Pregnancy increased the risks of female-to-male HIV transmission twofold among over 3300 serodiscordant couples from seven African countries, Nelly R Mugo and colleagues reported in a prospective study published in the advance online edition of AIDS.

The risks of becoming infected with HIV during pregnancy increased at the same rate. However, this was partly explained by other factors, including unprotected sex.

Women now account for 60% of HIV infections in adults in sub-Saharan Africa. Many African countries with high HIV prevalence also have high fertility rates and often women are pregnant for a considerable proportion of their adult lives.

Pregnancy brings biological and behavioural changes that may make a woman more susceptible to getting HIV, as well as making her more infectious, so increasing the risks of transmission.

To date, limited prospective studies have found inconsistent results, showing either an increased risk or no elevated risk of acquiring HIV during pregnancy. However, evidence shows that women infected during their pregnancy have a high rate of HIV transmission to their infants.

The authors note one study which showed increased HIV shedding in genital secretions during pregnancy, suggesting increased infectiousness, yet no prospective study has looked specifically at pregnancy as a risk factor for female-to-male transmission.

The authors chose to look at the association between pregnancy and the risks of getting HIV, as well as the risks of transmitting HIV from females to males, in a secondary analysis of a prospective study of African HIV serodiscordant couples.

From November 2004 to April 2007, 3408 HIV serodiscordant couples from Botswana, Kenya, Rwanda, South Africa, Tanzania, Uganda and Zambia were enrolled in the Partners in Prevention HSV-2/HIV transmission study, a randomised, placebo-controlled, clinical trial of aciclovir as herpes simplex virus-2 (HSV-2) suppressive therapy for the prevention of HIV transmission. Aciclovir did not decrease HIV transmission risk within the couples.

Of the 3321 couples in the analysis, about a third (1085) included an HIV-positive male partner and the remaining two-thirds (2236) included an HIV-positive female partner. Eligibility included being over 18 years of age, having three or more episodes of vaginal intercourse in the three months before screening, and having the intention of remaining a couple.

HIV-positive partners were positive for HSV-2, had CD4 cell counts over 250 cells/mm3 and were not taking antiretrovirals. HIV-positive women pregnant at the time of screening were excluded from the study. Women who became pregnant stopped the study medication until the end of pregnancy. Pregnant HIV-negative women were included, as were those who became pregnant during follow-up.

HIV-positive partners were seen monthly, and HIV-negative partners were seen every three months. Sexual behaviour data including condom use was recorded at each visit, as was contraceptive use.

Comprehensive prevention services included individual and couple HIV-risk-reduction counselling, quarterly syndromic management of sexually transmitted infections, STI treatment and free condoms.

The majority were married and living together. Median CD4 cell count was 461 cells/mm3. The couples were followed for up to 24 months; median time for HIV-negative and HIV-positive partners was 20.9 months (IQR: 15.6-24.1) and 19.9 months (IQR: 14.3-23.9), respectively.

Of the 61 HIV seroconversions among women, close to 30% (17) happened during pregnancy. HIV incidence during pregnancy was 7.35 per 100 person years compared to 3.01 per 100 person years during non-pregnant periods,  (HR: 2.34, 95% CI: 1.33-4.09, p=0.003). Risk was high during both early and late pregnancy. However, in multivariate analysis after controlling for age, contraceptive use and unprotected sex, the effect of pregnancy on HIV risk was not statistically significant.

Of the 58 HIV transmissions to men, 12 (20.7%) happened during pregnancy. The incidence of female-to-male transmission was 3.46 per 100 person-years during pregnancy, compared to 1.58 per 100 person-years when the female partner was not pregnant. This was statistically significant  (HR  2.31, p=0.01) and remained significant after adjusting for confounding factors (HR.2.47, p=0.01).

The authors underscore the public health importance of these new findings showing pregnancy increases the risk of female-to-male transmission twofold. New strategies, they add, are needed “to strengthen family planning and maternal health services for women with and at risk for HIV in order to reduce unwanted pregnancies and avert HIV transmission to pregnant women and from pregnant women to their infants and partners”.

Strengths of the study include a large sample size and multinational cohort. The study also established a genetic viral linkage of transmitted HIV within partnerships, so minimising the potential for misclassification of female-to-male transmission.

The authors note their findings can be generalised; all participants were co-infected with HSV-2, as are over 80% of all HIV-positive adults in sub-Saharan Africa.

The authors conclude increased risk for HIV female-to-male transmission during pregnancy requires “further studies to understand the possible biologic mechanisms that may explain this finding”. They add: “Prenatal couples' HIV counselling and testing, implementation of repeat HIV testing in pregnancy, and earlier initiation of combination ART should become part of routine antenatal care to protect mothers, infants and male partners from HIV.”

Taken from Aidsmap, 8 August 2011

Posted: August 9, 2011 by Nozizwe (updated October 26, 2011)

Rome IAS conference is 'landmark moment' for HIV science, say experts

The Sixth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention opened on Sunday night in Rome amid great excitement, with scientific leaders proclaiming that the conference will be a landmark moment in the history of HIV research.

“We are at a scientific watershed in the global AIDS response,” said IAS 2011 International Chair and International AIDS Society President Elly Katabira.

“We have witnessed two years of significant biomedical advances, the likes of which we have not seen since the antiretroviral breakthroughs of the mid-1990s.”

“The excitement around these advances in research – whether they be the CAPRISA 004 vaginal gel, the HPTN 052 study on treatment as prevention, talk around the path towards a cure, or the encouraging signs on PrEP and vaccines – is very much driving the debates and discussions that we are going to see in Rome over the next few days.”

Over 5000 delegates are gathered in Rome this week for the year’s largest scientific meeting on AIDS, after two months of stunning scientific news.

In May, results from a trial of antiretroviral treatment of the HIV-positive partners in couples where one partner was uninfected showed that early treatment reduced the risk of infection by 96%.

Last week, results from two studies were released, showing that when people without HIV infection take one or two antiretroviral drugs (either tenofovir or tenofovir in combination with emtricitabine), the risk of becoming infected with HIV is reduced by somewhere between 62% and 78%, depending on the drugs used and how consistently they are taken.

And in early June, buoyed by the results of the 'treatment as prevention' study, governments meeting together at the United Nations in New York agreed a target of expanding antiretroviral treatment to reach 15 million of those in need by 2015.

But the key challenge will be how to make these breakthroughs available in such a way that they perform just as well when scaled-up to millions of people, and how to fund them.

“We have to remember that history will judge us not by our scientific breakthroughs, but how we apply them,” said Michel Sidibé, executive director of UNAIDS, speaking at the opening ceremony.

Dr Katabira, who was one of the first doctors to treat AIDS patients in Uganda, said that while the chances of stopping the HIV pandemic have “just got enormously better, the challenges have got bigger. In our part of the world proof is not enough.”

“If politicians continue to think we can do small things here and small things there, we will not do it.”

Michel Sidibé said: “Sceptics are saying that expanding treatment is risky and unsustainable. What is truly risky, truly unsustainable, is waiting for treatment.”

“We pay now, or we pay forever!” he added.

But he pointed to the fact that domestic contributions to funding the cost of the AIDS response, and higher burden countries, now accounted for 53% of all funding.

A radical mismatch now existed on the donor front, he went on, between the biggest donors such as the United States and the United Kingdom, and other wealthy countries which gave next to nothing to support the Global Fund to Fight AIDS, Tuberculosis and Malaria, and other programmes.

Italian activists were critical of host country Italy, for its failure to live up to its promises on AIDS.

“The promises of our Prime Minister to contribute to the Global Fund since 2009 are totally failed. Italy owes $290 million,” said Filippo von Schloesser of the Italian HIV activist network Nadir ONLUS.

He also accused the Italian government of seeking to undermine the concept of harm reduction in United Nations negotiations, at a time when international agencies leading the fight against HIV are trying to persuade countries in Eastern Europe and Asia of the importance of harm reduction methods for limiting the HIV epidemic among injecting drug users.

The International AIDS Society conference runs until Wednesday.

Follow Keith Alcorn at the IAS 2011 conference on Twitter @keithalcorn

This news report is also available in French

 

Taken from Aidsmap, 25 July 2011

Posted: July 25, 2011 by Nozizwe (updated October 26, 2011)

New Clinic Opens at Royal South Hants (RSH) Hospital

The HIV Prevention Service are pleased to announce that staff will be available at a new clinic at the Sexual Health Services (formerly GUM) department at the Royal South Hants (RSH) Hospital in Southampton on the first and third Friday of the month from 9.30am to 1.00pm.

You will be able to make an appointment and talk about the following issues:

• HIV Issues, including why you should you test, what HIV means in todays lifestyles;
• Questions around Sexuality;
• Cultural Issues around Sexual Health;
• and other general sexual health information and advice.

If you want to talk to someone from the HIV Prevention Service while you are at the Sexual Health Services department, please ask at reception or call 0300 123 SEXY (0300 123 7399) to make an appointment, or call 0845 643 9399 for more details.

Posted: July 25, 2011 by Pete (updated September 28, 2011)

Bacterial vaginosis raises women's risk of transmitting HIV

A man who is in a relationship with an HIV-positive woman has a three times higher risk of acquiring HIV if his partner also has bacterial vaginosis, Craig Cohen told the Sixth International AIDS Society conference in Rome today. Whereas it has been previously established that bacterial vaginosis increases a woman’s risk of acquiring HIV, this is the first time that it has been shown to increase her risk of transmission to sexual partners.

Bacterial vaginosis (BV) is a condition which occurs when the normal balance of bacteria in the vagina becomes disrupted. This can result in an over-growth of certain bacteria (flora), which may be accompanied by symptoms such as discharge, itching and pain. It can sometimes cause pelvic inflammatory disease and lead to problems with fertility and childbirth.

A number of prospective studies have established that having BV is associated – for women – with an increased risk of acquiring HIV. Studies on men’s risk of acquiring HIV when their sexual partners have bacterial vaginosis have not previously been conducted.

However, some studies have shown that BV is associated with an increase of HIV viral load in the genital tract. There is also evidence that HIV-positive women who have bacterial vaginosis when they give birth are at greater risk of passing HIV on to their child.

Craig Cohen presented an analysis of data on couples recruited to the Partners in Prevention study, conducted in seven countries of southern and eastern Africa. There were 2236 HIV-negative men in the cohort who had an HIV-positive female partner. Both partners were followed for up to two years.

Couples had been together for a median of five years and three-quarters were married. A third reported having unprotected sex, although condoms and counselling were provided by the researchers. The HIV-positive partner had to have a CD4 cell count above 250 cells/mm3 and not be on HIV treatment at the start of the study.

Across over 10,000 study visits at which vaginal flora was assessed, 34.9% of women had bacterial vaginosis, 22.8% had intermediate flora and 42.8% had normal flora.

During the course of the study, 57 of the men became HIV positive when HIV genotyping (env and gag) could confirm that they had similar virus to that of their partner. In other words, they probably hadn’t acquired HIV outside the primary relationship.  

The investigators then identified the measurement of vaginal flora for their partner that was taken closest to the estimated date of seroconversion (no more than three months previously). This data was missing for seven women, leaving 50 couples in the analysis.

Nine HIV transmissions originated from women with normal flora, ten from women with intermediate flora and 31 from women with bacterial vaginosis.

After controlling for a large number of potentially confounding factors (sociodemographic, behavioural and biological), men whose partners had BV had a three times higher risk of acquiring HIV than other men (hazard ratio 3.06, 95% confidence interval 1.35 – 6.95).

Women with BV did have higher genital viral loads (3.23 log, compared to 3.04 log in women with normal flora). This was statistically significant, but Cohen suggested that it probably isn’t clinically significant.

He advanced two other hypotheses that could explain the increased risk to male partners. Firstly, that normal bacteria may be virucidial against HIV, reducing the proportion of virus that is infectious. Secondly, that bacterial vaginosis could indirectly increase the male partner’s susceptibility to HIV. Cohen noted that long-term sexual partners share genital flora, with men acquiring bacteria from their partners. It is possible, he suggested, that bacteria may activate Langerhans cells and CD4+ T-cells, making the man more susceptible to HIV infection.

A significant challenge in acting on this research is that current treatment strategies for bacterial vaginosis are inadequate, with low cure rates and the problem often recurring

 

Taken from Aidsmap, 25 July 2011.

Posted: July 25, 2011 by Nozizwe (updated July 25, 2011)

Men's Health Week Competition Winner Announced

Over the period of Men's Health Week in June (13th - 19th) the HIV Prevention Service asked men from the Hampshire area to complete a survey about men's health.

Each man that completed the survey was entered into a competition to win £40 high street vouchers as a thank you.

The HIV Prevention Service are pleased to announce that a winner has been drawn randomly from all the entries received. A man from Basingstoke was declared the winner and was contacted by one of our team about receiving his vouchers.

We would like to thank everyone that completed the survey for their time and effort.

Posted: July 21, 2011 by Pete (updated August 3, 2011)

HIV treatment – PrEP works

Initial findings were released today from two large studies showing that pre-exposure prophylaxis can cut the risk of HIV infection by up to 73% in heterosexual couples.

Pre-exposure prophylaxis (PrEP) involves people who are HIV-negative taking anti-HIV drugs to prevent HIV infection.

The Partners study, which took place in Kenya and Uganda, gave participants either tenofovir (Viread), Truvada (tenofovir and FTC) or a placebo. Infections were reduced by 62% in people taking tenofovir alone and by 73% in those taking Truvada. The study was ended more than 18 months early because early results showed PrEP was so effective.

Participants in the TDF2 study, in Botswana, took either Truvada or a placebo; Truvada reduced infections by 63%.

Co-chair of the Partners study, Dr Jared Baeten, says: “This is a very exciting finding for the field of HIV prevention. Now … the priority for HIV prevention research must be on how to deliver successful prevention strategies, like PrEP, to populations in greatest need.”

These findings add to the picture of effectiveness of PrEP, following recent conflicting findings from the iPrEX study and the FEM-PrEP trial.

More detailed findings from the TDF2 study will be presented at the IAS conference in Rome next week, and NAM will report on these in our daily bulletins from the conference (see box to the right). You can also visit our online ‘Pre-exposure prophylaxis’ resource for more discussion and information on previous research.

Taken from HIV Weekly, 13 July 2011

Posted: July 14, 2011 by Nozizwe (updated October 26, 2011)

HIV and children – managing the risk of heart disease

It’s now well established that people with HIV have an increased risk of cardiovascular disease (CVD).

There a lot of debate about the causes, but the most important seem to be the damage caused by untreated HIV infection, and traditional risk factors such as smoking. Some studies have shown that treatment with some anti-HIV drugs increases the risk of heart disease.

Now, a US study has found that children with HIV who developed high cholesterol (or lipid levels, a risk factor for cardiovascular disease) still had high cholesterol when followed up two years later.

Controlling cholesterol levels in children is important as they are likely to spend many years on HIV treatment. The researchers are concerned that there is no standard guidance on how cholesterol levels are managed in children with HIV. They recommend that formal guidelines be developed, taking a combined approach to managing cholesterol levels (and CVD risk) including ‘lipid-friendly’ anti-HIV drugs, lifestyle changes and the use of statins (lipid-lowering drugs).

Routine HIV care involves regular tests to monitor cardiovascular health, meaning that problems can be spotted early and appropriate action taken.

There’s also a lot you can do to look after your heart – for example not smoking, eating a healthy diet, and exercising regularly – help and advice about all these is available from your HIV clinic or GP.

 

Taken from HIV Weekly, 13 July 2011

Posted: July 13, 2011 by Nozizwe

HIV treatment – abacavir as effective as tenofovir

The abacavir/3TC nucleoside combination is as potent as tenofovir/FTC, Canadian investigators report in the online edition of the Journal of Acquired Immune Deficiency Syndromes.  The study involved patients starting HIV therapy for the first time.

There was no difference in the risk of virologic failure between the two combinations. Importantly, the study showed that abacavir/3TC (usually combined in the pill Kivexa) and tenofovir/FTC (co-formulated in Truvada and with efavirenz in Atripla) had similar virologic efficacy in patients with a pre-treatment viral load above 100,000 copies/ml.

The investigators believe that their results show that abacavir/3TC should be reinstated alongside tenofovir/FTC as a “preferred” nucleoside backbone in US guidelines for patients starting HIV therapy.

Results of the study will provide reassurance for patients in London where abacavir/3TC is now routinely prescribed as the nucleotide component of first-line antiretroviral therapy.

There has been recent controversy about the effectiveness of abacavir-containing HIV therapy. The ACTG 5202 study showed that patients who had a baseline viral load above 100,000 copies/ml when they started abacavir/3TC had a shorter time to virologic failure than patients treated with tenofovir/FTC.

Doubts have also been cast over the safety of abacavir. Some observational studies found an association between the drug and an increased risk of heart attack (however, a recent analysis of randomised studies failed to replicate these findings).

Because of these concerns, the status of abacavir/3TC downgraded in US treatment guidelines from a “preferred” to an “alternative” regimen for patients starting HIV therapy. However, it still remains a preferred first-line option in Europe.

Canadian investigators wished to establish a clearer understanding of the virologic efficacy of abacavir/3TC.

They therefore undertook a retrospective study involving patients who started HIV therapy for the first time after 2000.

A total of 1764 individuals were included in their analysis, with 588 receiving abacavir/3TC, and 1176 tenofovir/FTC. The patients took these nucleoside backbones in combination with a third antiretroviral drug. The analysis excluded patients who were injecting drug users.

Data were gathered on a number of virologic outcomes, including the risk of treatment failure, time to treatment failure, baseline viral load and the risk of failure, and treatment changes.

Treatment failure was defined as either:

• a viral load above 1000 copies/ml after week but before week 24

• A viral load above 200 copies/ml at or after week 24

• Switching the nucleoside pair for any other reason.

• The researchers also considered each of these definitions separately.

There were important baseline difference between the abacavir/3TC- and tenofovir/FTC-treated patients.

Abacavir-treated patients were significantly more likely than those taking tenofovir to have a viral load at the start of treatment above 100,000 copies/ml, and these patients also started antiretroviral therapy a median of two years earlier than those taking tenofovir/FTC.

The first set of analyses showed that treatment with abacavir/3TC was associated with a modest but still significant increase in the risk of virologic failure (HR = 1.19; 95% CI, 1.01-1.39).

However, this association disappeared when the investigators took into account a number of potentially confounding factors (aHR = 0.96%; 95% CI, 0.80-1.17). These confounding factors comprised sex, province, third antiretroviral drug, province and year of treatment initiation.

There was no association between abacavir therapy and an increased risk of virologic failure for patients who had a baseline viral load above 100,000 copies/l (aHR = 0.92; 95% CI, 0.69-1.22).

Analysis also showed that there was no difference in the time to virologic failure between the two regimens (abacavir/3TC: aHR = 0.84; 95% CI, 0.58-1.20).

The time to switching or changing nucleoside drugs was comparable between abacavir and tenofovir-containing regimens.

Concerns about the cardiovascular safety of abacavir were first reported in February 2008. The investigators therefore looked at the calendar date patients stopped or switched therapy. The median month of treatment change for patients treated with abacavir/3TC was May 2006, and June 2008 for individuals taking tenofovir/FTC.

After 24 weeks of therapy, abacavir/3TC- and tenofovir/FTC-treated patients had a similar probability of achieving an undetectable viral load (0.55 and 0.60 respectively). The median time to the achievement of this outcome was four weeks for both regimens.

The investigators noted increased rates of treatment failure associated with either nucleoside pair in women, and in patients resident in Ontario or Quebec provinces, and  a higher risk of virologic failure in patients also receiving a boosted protease inhibitor.

“We detected no statistically significant differences in the time to regimen failure, virologic failure, switching or stopping antiretroviral agents for non-virologic failure reasons, or virologic suppression according to NRTI backbone,” write the investigators, who conclude “these results support the use of either NRTI backbone in initial therapy of ART-naïve patients, and would support continuing ABC/3TC as a ‘preferred’ NRTI option.”

 

Taken from HIV Weekly, 13 July 2011

Posted: July 13, 2011 by Nozizwe (updated October 26, 2011)

HIV and cancer

Some types of cancer are more common in people with HIV than in the general population. Some of these cancers are considered AIDS-defining illnesses, such as Kaposi's sarcoma (KS), non-Hodgkin's lymphoma (NHL) and cervical cancer.

A recent study has found that people whose immune system is badly damaged are at greater risk of developing AIDS-defining cancers, not only before starting treatment but also in the first three months after starting.

Researchers confirmed that people whose CD4 count was low in the year before starting treatment were at increased risk of these cancers, and also noted that CD4 counts fell faster in people who went on to develop AIDS-defining cancers.

The study also found there was an increased risk of developing cancer (especially Kaposi’s sarcoma or non-Hodgkin’s lymphoma) in the first three months after starting treatment. Researchers link this to a condition called immune reconstitution inflammatory syndrome (IRIS). This is when someone becomes more ill on starting HIV treatment, as their immune system gets stronger and starts to fight any infections present. IRIS is more common in people whose CD4 count was low when they started treatment (under 100) or who have another illness, such as tuberculosis (TB); the symptoms of that illness may become worse.

Previous research has shown that Kaposi’s sarcoma can be linked to IRIS. The aim of this new study was to get a better understanding of the risk of developing AIDS-defining cancers after starting HIV treatment, and whether IRIS did increase the risk.

The researchers found that the risk grew in the period immediately after starting HIV treatment. Researchers believe this is because Kaposi’s sarcoma and non-Hodgkin’s lymphoma are linked to viral infections, which may become more severe if someone develops IRIS.

However, their key conclusion is that the main risk factor for AIDS-defining cancers is a damaged immune system, and that starting HIV treatment is the most effective way to reduce the risk of developing such cancers.

Other cancers are not regarded as AIDS-defining because their higher rates have not been definitely linked to a damaged immune system. However, they are often still more common among people with HIV. These include Hodgkin's disease, anal cancer and lung cancer. A key risk factor for some of these cancers is smoking, which can also cause heart disease and other health problems. Stopping smoking (or not starting in the first place) will significantly reduce your risk of developing these conditions.

If you want to give up smoking, talk to your doctor or another member of your healthcare team about the support available to you. In the UK, most NHS trusts offer support with stopping smoking. You can call the NHS Stop Smoking Helpline on 0800 022 4 332 or visit the NHS website www.smokefree.nhs.uk.

 

Taken from HIV Weekly, 12 July 2011

Posted: July 13, 2011 by Nozizwe (updated July 19, 2011)

Lipodystrophy – body fat changes

Researchers confirmed this week that the use of modern HIV drug regimens is not associated with the loss of fat in the arms and legs. In fact, people tend to gain fat in their limbs, perhaps because their general health is improving.

‘Lipodystrophy’ is a medical term referring to changes in body fat and is a side-effect of some HIV treatments. Lipodystrophy includes both fat gain (for example, around the waist) and fat loss (for example from arms and legs, which makes the veins more prominent).

American researchers followed 269 people who were starting HIV treatment for just under two years. People were randomly assigned to one of four different combinations of anti-HIV drugs. The drugs used included abacavir and 3TC (in the combined pill Kivexa); tenofovir and FTC (in the combined pill Truvada); efavirenz (Sustiva); and ritonavir-boosted atazanavir (Reyataz).

At the end of the study, body scans showed that limb fat levels had increased by an average of 23%. People taking atazanavir gained more fat on their limbs than people taking efavirenz. People who had a higher viral load to start with gained more fat, suggesting that they put on weight as their overall health improved.

Only 5% of people lost more than 20% of their limb fat.

The researchers say that their results provide reassurance that Kivexa and Truvada do not cause fat loss. Older drugs such as d4T (stavudine, Zerit) and AZT (zidovudine, Retrovir) are associated with much higher rates of fat loss.

However the study did find that people in the study did also gain weight around the waist, including increases in ‘visceral fat’. This is fat which accumulates around the internal organs, causing the belly to feel taut and pushed out; it is the kind of fat gain which may be a drug side-effect.

Increases in visceral fat were larger in people taking the protease inhibitor atazanavir (boosted with ritonavir) than in people taking efavirenz. Greater increases in visceral fat were also more common in people who were fatter to begin with.

If you are concerned about any side-effects you are experiencing, or concerned about the possible side-effects of a drug you are taking, talk to your doctor or another member of your healthcare team.

You can find out more about dealing with side-effects in NAM’s booklet Side-effects. It is available on our website in English, Dutch, French, German, Hebrew, Norwegian, Polish, Russian, Spanish and Swedish.

 

Taken from HIV Weekly, 6 July 2011

Posted: July 6, 2011 by Nozizwe

Giving up smoking

People with HIV tend to be more likely to smoke than people in the general population and smoking-related diseases are a major cause of illness and death in people with HIV. But surprisingly little research had been conducted with HIV-positive smokers into programmes to help them quit smoking.

Now a study has found that a mobile phone counselling service can help people with HIV to stop smoking.

Researchers in an urban part of Texas recruited 474 HIV-positive smokers who wanted to quit. Most people taking part were socially disadvantaged.

Everybody received brief advice about how to stop smoking, written information and nicotine replacement therapy (such as patches or gum). Half the group received no further support, while the other half were given a mobile phone, eleven counselling sessions over the phone and a hot-line number to call at other times.

Smoking rates were measured after three months. Amongst those who didn’t get more support, just 2% managed to quit, but this rose to 9% in those who had phone counselling.

The study suggests that more needs to be done to help this group give up smoking, but that support over the phone could be part of the solution.

If you want to give up smoking, talk to your doctor or another member of your healthcare team about the support available to you. In the UK, most NHS trusts offer support with stopping smoking. You can call the NHS Stop Smoking Helpline on 0800 022 4 332 or visit the NHS website www.smokefree.nhs.uk.

 

Taken from HIV Weekly, 6 July 2011

Posted: July 6, 2011 by Nozizwe (updated July 19, 2011)

Kivexa- and Truvada-based combinations associated with long-term gains in limb

Modern antiretroviral regimens based on Kivexa and Truvada are associated with long-term gains in limb fat, US investigators report in the July 15th edition of Clinical Infectious Diseases.

After 96 weeks of therapy limb fat levels had increased by approximately 25% in patients treated with Kivexa (abacavir and 3TC) and by 21% in patients taking Truvada (tenofovir and FTC). 

These results provide reassurance that the nucleoside/nucleotide backbones used in modern HIV therapy do not cause the fat loss, or lipoatrophy associated with the older drugs, d4T (stavudine, Zerit) and AZT (zidovudine, Retrovir).

Visceral fat gain – accumulation of fat around the organs – was somewhat more likely to occur with atazanavir (Reyataz) rather than efavirenz (Sustiva, also in the combination pill Atripla), and was associated with baseline obesity.

The study involved 269 HIV-positive patients enrolled in the ACTG A5224s study. All were starting HIV therapy for the first time. They were treated with open-label ritonavir-boosted atazanavir or efavirenz, which was used in combination with blinded Kivexa or Truvada.

Both DEXA and CT scans were used to assess changes in limb and visceral fat.

Recruitment to the study took place between 2005 and 2007, and 96-week follow-up data were published by the investigators.

Most of the patients (85%) were male and 47% were white. The median age at baseline was 38 years, and median body mass index at this time was 24.9 kg/m2. Median limb fat was 7.4 kg, median trunk fat was 9.4 kg, and median visceral adipose tissue was 84.1 cm2.

At the time HIV therapy was started, the patients had a median CD4 cell count of 233 cells/mm3 and median viral load was 4.6 log10 copies/ml.

Lipoatrophy was defined as fat loss of at least 10% after 96 weeks. It was diagnosed in 18% of patients treated with Kivexa and 15% of patients taking Truvada.

Fat loss of 20% of greater from the limbs occurred in approximately 5% of patients.

The investigators note that this prevalence of fat loss was significantly lower than the 50%-70% seen among patients treated with d4T or AZT.

Moreover, DEXA scans showed that overall limb fat had increased by 1.66 kg or 25% in patients taking Kivexa, and by 1.11 kg or 21% among Truvada-treated patients.

Limb fat changes were significantly greater for patients taking ritonavir-boosted atazanavir than for those treated with efavirenz.

The estimated overall increased in trunk fat at week 96 was 1.83 kg or 28%, with similar gains seen in the Kivexa- and Truvada-treated patients.

Greater gains in trunk fat were however seen in patients taking atazanavir-ritonavir than in those treated with efavirenz (2.42 kg, 37% vs. 1.33 kg, 21%).

Neither Kivexa nor Truvada were associated with gains in visceral fat. However, slightly larger increases in visceral fat were seen in patients taking atazanavir than among individuals treated with efavirenz (30% vs. 15%).

Therapy with atazanavir-ritonavir was associated with greater increases in BMI than treatment with efavirenz (p = 0.022).

A higher baseline viral load was associated with significantly greater increases in limb fat (p < 0.001). The investigators suggest that this is consistent with limb-fat gains being “mediated by the return-to-health phenomenon.” Older age was associated with significantly greater losses in limb fat. (p = 0.02).

Higher baseline BMI was associated with increases in visceral fat. The investigators suggest “this could be linked to the enhanced inflammation associated with obesity.”

The authors conclude “very few subjects in any study arm met [the] criterion for lipoatrophy.” They suggest “studies aimed at better understanding and preventing lipohypertrophy after ART initiation are needed.”

 

Taken from Aidsmap, 4 July 2011

Posted: July 4, 2011 by Nozizwe

Some older HIV drugs linked to premature ageing

Older antiretroviral drugs still widely used in low and middle-income countries accelerate a process of mutation within the DNA of mitochondrial cells that has been linked to ageing, scientists from Newcastle University report in the journal Nature Genetics.

The authors of the study say that their findings raise the spectre of the large-scale emergence of early ageing in people treated with the older nucleoside analogues over the next decade. However, more studies will be needed to confirm these findings.

They also note that even in people no longer taking the drugs, the past mutations in mitochondrial DNA caused by AZT (zidovudine, Retrovir, also in Combivir), d4T (stavudine, Zerit) and ddI (didanosine, Videx) cannot be repaired by normal cellular mechanisms.

They estimate that any ageing effects of the drugs are likely to be greater when taken by older people.

There is some evidence of accelerated ageing in individuals with HIV disease, including a higher prevalence of frailty, deterioration in lower-limb strength, modest declines in physical function when compared to HIV-negative adults of the same age, and declines in limb muscle.

It is unclear to what extent these conditions are caused by antiretroviral treatment, or if they are the long-term consequence of past opportunistic infections. The fact that these problems tend to occur in individuals over the age of 50, who were likely to have been diagnosed with AIDS and to have suffered a series of opportunistic infections that may have resulted in permanent physical disability and reduced physical function, suggests that the notion of accelerated ageing may disguise the fact that many people with long-term HIV infection continue to experience poor health despite successful antiretroviral treatment.

Furthermore, other diseases of ageing that occur in people with HIV are either related to lifestyle, or strongly associated with immunosuppression. Examples include cancers and heart disease.

However, other forms of ageing, such as weight loss, ageing of the skin, fatigue and muscle loss, have been less comprehensively studied.

Some scientists argue that some of the manifestations of ageing are the result of the long-term accumulation of mutations in the mitochondrial DNA of human cells. Mitochondria are energy-producing bodies within cells. They are more prone to mutation when copying themselves because they lack the `proof-reading` mechanism present in other human cells.

However this explanation for ageing is not accepted by all scientists as the primary or predominant cause of age-related degeneration in bodily functions. Critics of the theory point to the vast array of factors that can cause cumulative cellular and tissue damage.

It is also unclear whether the mitochondrial changes are a cause of ageing, or just a reflection of larger processes at work in the ageing body.

In individuals without HIV mitochondrial disorders, some of them inherited, may develop, with symptoms ranging in severity from exercise intolerance to blindness, severe organ dysfunction and impaired growth, depending on the mutations and the tissues affected. These disorders are most likely to emerge in childhood.

Mitochondria in HIV infection

Nucleoside analogues can cause mutations in mitochondrial DNA and depletion of mitochondrial DNA.

Considerable research into the effects of nucleoside analogues on mitochondrial DNA has been carried out as a result of the recognition that many of the most serious toxicities of this class of antiretroviral drug are a consequence of mtDNA polymerase gamma inhibition. Side-effects linked to this mechanism include lactic acidosis, lipoatrophy (fat loss), myopathy (damage to skeletal and cardiac muscle) and liver failure.

The older nucleoside analogues d4T and ddI have a much greater effect on mitochondrial DNA than newer drugs such as abacavir and tenofovir. 3TC (lamivudine) and FTC (emtricitabine) appear to have very little effect on mitochondrial DNA. AZT (zidovudine) has an intermediate effect.

The Mitochondrial Research Group at Newcastle University’s Institute of Genetic Medicine, led by Professor Patrick Chinnery, investigated mitochondrial depletion in skeletal muscle in 33 HIV-infected adults below the age of 50 and compared the results with those of ten healthy age-matched HIV-negative controls.

They sought in particular to assess COX-SDH deficiency, a marker of ageing. COX-SDH deficiency in muscle fibre was no more common in untreated HIV-positive people (n=12) than in HIV-negative controls, but HIV-positive people treated with nucleoside analogues showed much greater frequency of COX-SDH-deficient muscle fibre (in some cases up to 10% of muscle fibre was deficient, compared to less than 0.5% in the control group).

The extent of the deficiency was strongly predicted by total lifetime nucleoside analogue exposure, not current treatment, “implicating a persistent and cumulative mitochondrial defect”, say the authors. The median duration of exposure was unspecified by the study authors.

The mechanism that led to COX-SDH deficiency was not loss of mitochondrial DNA, but the proliferation of mitochondrial DNA that contained mutations. Mitochondrial DNA proliferated in response to previous loss of DNA, and as a consequence existing age-related mutations were copied. Mitochondrial DNA from patients treated with nucleoside analogues contained a significantly higher number of mutations, to such an extent that the burden of mutations in patients with under 50 was equivalent to that seen in the over-80s.

However, the authors concluded that rather than increasing the rate of mutation in mitochondrial DNA, nucleoside analogue treatment is associated with a higher rate of clonal expansion, or bulk copying, of mitochondrial DNA containing age-related mutations.

This means that nucleoside analogue treatment which increases the rate of mitochondrial DNA turnover will have a much greater effect on markers of ageing if it is taken by older people with more pre-existing mutations. Those in the age range 40-50 would have a much higher chance of accumulating mutations than those in the 20030 age group.

“An HIV-infected individual treated with NRTIs during their third decade is predicted to develop ~5% COX deficient cells by age 60. This is similar to or exceeds that seen in the healthy very old.”

The authors say that one limitation of their methodology is that mutation rates could have been overestimated by the test they used to measure mtDNA mutations.

Validation of the findings in larger cohorts which can provide more information about antiretroviral exposure, immunosuppression and comorbidities will be needed, as will studies which look at correlations between mtDNA mutations, ageing and antiretroviral exposure in other cell types.

Mitochondrial toxicity is strongly correlated with the severity of immunosuppression, and mitochondrial damage is dependent on the extent to which a nucleoside analogue is phosphorylated, or taken up into the active form, by a particular cell type. Thus, if the Newcastle University group's hypothesis is correct, age-related mutation would be both drug and cell-type dependent, leading to a broad spectrum of early emergence of conditions normally seen in the elderly, rather than a single pattern of accelerated ageing.

 

 

Taken from Aidsmap, 4 July 2011

Posted: July 4, 2011 by Nozizwe (updated July 19, 2011)

Hepatitis C – treatment success

New research shows that drinking three cups of coffee a day increases the chances of hepatitis C treatment working. Treatment is available for hepatitis C, but it doesn’t always work.

It’s already known that drinking coffee is associated with improvements in pre-existing liver disease. The doctors who conducted this latest study are unsure of the reasons, but think that it could be related to caffeine.

Because of this, researchers in the US wanted to see if it also had an impact on hepatitis C treatment outcomes.

Their research involved 855 people with hepatitis C mono-infection (i.e. they were only infected with hepatitis C). They’d all received a previous course of treatment for the infection, but it hadn’t worked.

Information was obtained from the patients about their daily coffee consumption.

People who drank three or more cups of coffee each day were 80% more likely to have their hepatitis C cured than people who did not drink coffee.

No beneficial effects were associated with tea consumption.

The researchers want further clinical trials to be conducted to confirm if coffee has consistent benefits.

You can find out more about hepatitis C in NAM’s booklet HIV & hepatitis. It is available on our website in English, French, German, Italian, Portuguese, Russian and Spanish.

 

Taken from HIV Weekly, 29 June 2011

Posted: June 29, 2011 by Nozizwe (updated July 19, 2011)

HIV treatment – when to start

Starting HIV treatment when your CD4 cell count is around 500 has only minor additional benefits, compared to starting treatment with a CD4 cell count of 350, Australian researchers have reported.

There’s a lot of debate about the best time to start HIV treatment. Current British guidelines recommend that you should start treatment when your CD4 cell count falls to around 350. Anyone who is ill because of HIV is recommended to start taking treatment.

Given that HIV treatment requires a high level of adherence and is a lifelong commitment, it is important that people starting treatment feel ready to do so. Understanding the benefits of starting treatment earlier than currently recommended is important for doctors and patients when making decisions about when to start.

Some doctors favour earlier treatment, and there’s research showing that starting therapy at a CD4 cell count of 500 or above reduces the risk of illness and death compared to waiting until later.

A major study is currently underway comparing long-term outcomes in people who start treatment at different CD4 cell counts. Its results – due in 2015 – should clarify this important issue.

The latest research showed that earlier treatment was associated with only modest additional benefits. Starting treatment at a CD4 cell count above 500 didn’t mean that CD4 cell count increases were better in the long term.

Nevertheless, people whose CD4 cell count was above 650 at the time they commenced therapy had a lower risk of developing a new AIDS-defining illness or dying than people whose CD4 cell count was in the 350 to 500 range at the start of treatment.

It’s already very clear that starting treatment with a CD4 cell count of around 350 reduces the risk of HIV-related illnesses as well as heart, liver and kidney disease, and some cancers. At the moment, people with an increased risk of these illnesses are especially encouraged to start treatment when their CD4 cell count reaches 350.

 

Taken from HIV Weekly, 29 June 2011

Posted: June 29, 2011 by Nozizwe (updated July 19, 2011)

Play your cards right!

On July the 7th the HIV Prevention Service will be launching it's new HIV transmission and testing resource.

This pack of 52 playing crads will have 13 seperate facts about HIV, transmission and testing and will be free to anyone who wants a pack.

The team will be out on in the community giving away packs and dazzling you with their amazing card trick skills. 

If you want a pack please contact Andrew on Andrew.Smith@Solent.nhs.uk or 0300 123 9117

 

Posted: June 27, 2011 by Andrew (updated August 3, 2011)

USA Launches National HIV Testing Day - June 27th

The CDC (Centres for Disease Control and Prevention) in the USA is encouraging everyone from teenagers to people aged 64 to get tested for HIV. June 27th (Monday) is National HIV Testing Day

"HIV Testing is key to Prevention" and "HIV Testing saves lives" is the message that the CDC are trying to get across to everyone and that it is important to know your HIV status so you can take control of your life.

We recommend that you have a HIV test at least once a year, which is free and confidential from your local GUM clinic.

If you want to read the full article from the CDC website, please click here

If you want to find your local GUM clinic, please click here

If you want more information or if you have any questions, please call a member of the HIV Prevention team. Our contact details are on the right-hand side of the front page.

Posted: June 25, 2011 by Pete (updated July 19, 2011)

Police Warning about increase in theft from cars in New Forest

Police are warning motorists in the New Forest to lock their vehicles and remove all valuables following a rise in thefts from vehicles in the area.   

Over the past few months there has been an increase in reports of thefts from vehicles where the car has been left open or items of value are left in full view of passers by.   

New Forest District Chief Inspector Lucy Hutson said: “We are encouraging motorists to make a final check of their vehicle every time they leave it unattended. Have you locked it and removed all valuables from inside? If not please take a minute to do this.   

“We are doing all we can to reduce vehicle crime but we need the help of residents and visitors to the New Forest too. It is impossible for us to constantly monitor all vehicles and catch thieves in action every time a crime is committed.Please do your bit by removing the temptation for thieves in the first place.”   

Hampshire Constabulary offers the following crime prevention advice:   

·           Lock up your vehicle securely and garage the vehicle if possible 

·           Security mark all valuables and register at www.immobilise.com   

·           Don’t leave anything on display or hide it away, remove all valuables and tools from the vehicle   

·           Fit anti-theft number plate screws   

·           Use locking wheel nuts   

·           Consider installing an alarm   

·           Consider fitting a vehicle tracking system   

·           Display a Safer Vehicles card in your vehicle to deter thieves   

For further advice, or to report suspicious activity please contact your local Safer Neighbourhoods team on 101.

Posted: June 23, 2011 by Pete (updated June 25, 2011)

Sexual health – talking about sexual behaviour

The clinical guidelines that set out the levels of care for people with HIV (known as the BHIVA guidelines, developed by a panel of doctors and community advocates) say that people with HIV should have a full sexual history taken every six months. They also suggest that people with HIV should have a full sexual health screen every year.

Researchers looked at the medical records of people attending a London HIV clinic to see if this was happening. They found that a sexual history was taken from 88% of people who had been newly diagnosed with HIV, but only 37% of people coming to the clinic for routine follow-up appointments. The researchers suggest that healthcare workers should do more to assess patients’ risk of passing on HIV and to suggest ways they could reduce that risk.

Talking honestly to healthcare staff is important so they can give you the best possible care. Sexual health clinics should be very used to seeing all the communities affected by HIV in the UK, including gay men and Africans, so the service they offer you should be non-judgemental.

 

Taken from HIV Weekly, 22 June 2011

 

 

Posted: June 22, 2011 by Nozizwe

HIV damages B-cells as well as T-cells: new treatment targets identified

The signature effect of HIV infection, and the cause of AIDS, is disruption of the T-lymphocyte branch of the immune system and in particular the destruction of CD4+ T-helper cells.

A team of researchers at the US National Institute of Allergies and Infectious Diseases (NIAID) has now found that HIV also causes a very specific form of damage to the other half of the adaptive immune system, the B-cells, and in particular the memory B-cells, which recognise previously-experienced infections and generate antibodies against them.

By using probes to delete specific genes within B-cells, they discovered that HIV infection creates an unusual population of exhausted, non-responsive cells called tissue-like B-memory cells. In previous experiments with cells taken from HIV-negative people, they found that that these cells are characterised the activation of genes which cause the cell to produce proteins that inhibit the cell’s function and that two of these inhibitory proteins had an especially strong effect on B-cell function.

Now, in cells taken from people with HIV, they have found that, by deleting the genes that manufactured these inhibitory proteins, they could restore the anti-HIV activity of these B-cells, at least in the test tube, that this rejuvenated activity was long-lasting, and that the cells exhibited a number of other markers of increased immune activity.

Although the gene-therapy techniques used in these experiments were sophisticated and can cause unpredictable immune reactions in themselves, the inhibitory proteins thus identified could become new therapeutic targets.

Background

One of the puzzles of HIV infection has always been that, while the immune system does mount an antibody response to HIV – indeed it is these antibodies that are detected in the standard HIV test – this response only partially controls viral replication, and eventually fails to entirely.

B-lymphocytes are the bone-marrow cells and their job is to secrete antibodies. Antibodies are soluble protein molecules that either directly destroy foreign invaders, render them harmless, or tag them for destruction by other parts of the immune system.

A strong antibody response to a pathogen can either prevent an infection happening altogether or can clear it from the system. Once an infection is experienced, the body creates a population of ‘memory’ B-cells that swiftly mount an antibody response if the invading pathogen is encountered again.

Vaccines generally work by imitating an infection and thus setting up a memory B-cell response in advance of an actual infection. T-cells, the thymus cells, work in a similar way but destroy infected cells rather than manufacture antibodies.

In HIV infection, the body mounts a very strong antibody response in the first few weeks that partially works, bringing the viral load down from millions to, on average, about 50,000 copies/ml. However it does not contain viral replication any further or eliminate HIV infection, and eventually weakens so that the viral load increases again.

Research findings

Dr Lela Kardava and her team from NIAID discovered that people with HIV had an unusual subset of B-memory cells called tissue-like cells that were characterised by the presence, on their surface, of a variety of inhibitory receptor molecules. The cells behaved much the same as exhausted T-cells do in HIV infection: they were sluggish and failed to react to foreign substances and to HIV itself.

In a series of experiments, Kardava’s team knocked out specific genes coding for these inhibitory proteins and found that by doing so they were able to restore some of the B-cells’ antibody responses. They did so by incubating cells with pieces of small interfering RNA (siRNA), molecules that target and interfere with specific genes. Previous experiments in cells taken from HIV-negative people had shown that ‘downregulating’ the inhibitory proteins with siRNA led to an 80-90% increase in the ability of the B-cells to proliferate.

They deleted nine inhibitory molecules in turn in cells taken from a group of people with chronic HIV infection. These individuals were either not taking ARV therapy or had only recently started and had an average viral load of 2096 copies/ml, with an average CD4 count of 427 cells/mm3.

They found that the deletion of two inhibitory receptors called FCRL4 and SIGLEC6 had particularly strong rejuvenating effects. The siRNA targeting the genes coding for these proteins led to a 30-66% reduction in the expression of these proteins in the cell. This in turn led to a doubling of the number of cells which, in response to standard immune stimuli, secreted anti-HIV antibodies.

These responses were long-lasting; the anti-HIV antibody responses of the cells that had had FCRL4 and SIGLEC6 ‘downregulated’ (reduced) demonstrated a similar increase in responsiveness to HIV several weeks later. Cells with the downregulated inhibitory proteins also secreted five times as much of the powerful pro-inflammatory chemical (cytokine) interleukin-6 and 50% more of the chemokine MIP-1α, indicating that modulating B-cell exhaustion may have a number of other immune-modulating effects.

Implications

The NIAID team are working on the hypothesis that the exhaustion seen in the B-cells of people with HIV is very similar to that seen in T-cells: the cells essentially stop working as a defensive manoeuvre against a virus whose constant stimulation would otherwise cause more damage by exciting the body into a constantly inflammatory state.

If, however, therapies could be devised than enabled B-cells to mount better antibody responses to HIV without undesirable side-effects, they could in theory form part of a ‘functional cure’ that rendered HIV infection less harmful – or might even be part of a way to eliminate HIV from the body.

The NIAID team say: “Our findings suggest that the development of strategies aimed at reversing the deleterious effects of these inhibitory receptors may improve immune responses against...persisting viruses.”

 

Taken from Aidsmap, 20 June 2011

Posted: June 21, 2011 by Nozizwe

Low CD4 cell count increases risk of non-AIDS-defining cancers for patients

A CD4 cell count below 200 cells/mm3 is associated with an increased risk of infection-related non-AIDS-defining cancers in patients taking antiretroviral therapy, Dutch investigators report in the June 15 edition of Clinical Infectious Diseases.

Older age and certain viral co-infections also increased the risk.

The investigators believe that their findings support the prompt initiation of antiretroviral therapy, and that cancer screening should be included in routine HIV care.

“Current guidelines recommend starting cART [combination antiretroviral therapy] at CD4+ cell counts which are higher than the levels of immunodeficiency that we found to be associated with an increased risk of developing malignancies, which might help in preventing malignancies in such patients,” comment the authors.

“Screening for anal human papilloma virus infections and premalignant lesions, counselling patients to quit smoking, and vaccinating against HBV [hepatitis B virus] could…reduce the incidence of non-AIDS-defining malignancies in the HIV-1 infected population treated with cART.”

Effective antiretroviral therapy means that many HIV-positive patients now have a near-normal prognosis. However, an accumulating body of research has shown that even with this treatment, individuals with HIV have an increased risk of developing some non-AIDS-related cancers.

The exact reasons for this are uncertain, but risk factors appear to include HIV-related issues such as viral load and immune suppression; smoking; and viral co-infections such as anal, cervical and oral human papilloma virus, hepatitis B and/or hepatitis C, and Epstein-Bar virus.

Investigators from the Dutch ATHENA cohort therefore designed a study to explore the role of various HIV-related and infection-related risk factors in the development of non-AIDS-defining cancers in patients taking antiretroviral therapy.

Their study sample involved 11,459 patients who started combination HIV therapy after 1996. Patients were followed until early 2009, and the median duration of follow-up per patient was 4.8 years.

Traditional risk factors for cancer were common. Most of the patients (74%) had a history of smoking and alcohol abuse was reported in 7% of individuals.

Prevalence of infections related with cancers was also high. Rates of hepatitis B and hepatitis C infection were 5% and 6% respectively.

A total of 236 non-AIDS-defining cancers were diagnosed, 43% of which were related to infections.

These included 37 cases of anal cancer, 24 head and neck cancers, 16 diagnoses of liver cancer, 24 cases of Hodgkin’s lymphoma, one case of gastric cancer, and four individuals developed cancer of the vulva.

Common non-infection-related malignancies included lung cancer (44 cases), pancreatic cancer (five instances), renal cancer (four diagnoses), bladder cancer (six cases), and testicular cancer (eight cases).

Risk factors for the more common cancers were examined in detail.

Nearly all the patients (35) who developed anal cancer were men, and 27 reported sex with another man. Longer duration with a CD4 cell count below 200 cells/mm3 (hazard ratio [HR], 1.52; 95% CI, 1.24-1.87 for every additional year), and a CD4 cell count between 200-350 cells/mm3 (HR = 1.29; 95% CI, 1.02-1.62) were significant risk factors for anal cancer.

Other risks included older age (HR for each ten-year increase, 1.35; 95% CI, 1.07-14.70), and an AIDS diagnosis before the initiation of HIV therapy (HR, 2.02; 95% CI, 1.06-3.83).

All the patients with liver cancer were men, and eight were co-infected with hepatitis B and three with hepatitis C.

The strongest risk factor for this malignancy was co-infection with hepatitis B virus (HR, 26.6; 95% CI, 9.7-72.99). Other risk factors included older age (HR, 2.06; 95% CI, 1.32-3.23), alcohol abuse (HR, 4.0; 95% CI, 1.12-14.30). Co-infection with hepatitis C virus was not significant.

Older age was a significant risk factor for lung cancer (HR per each additional decade, 2.0; 95% CI, 1.61-2.50), but surprisingly, smoking fell just short of statistical significance (HR, 7.34; 95% CI, 0.96-55.90).

Further analysis showed that severe immune deficiency increased the overall risk of non-AIDS-defining cancers (each additional year of a CD4 cell count below 200 cells/mm3, HR, 1.12; 95% CI, 1.03-1.22).

The was also trend close to statistical significance for longer duration with a CD4 count below 350 cells/mm3 (HR, 1.08; 95% CI, 0.99-1.18).

Other risk factors included chronic hepatitis B infection (HR, 1.77; 95% CI, 1.08-2.91), older age (each additional decade, HR, 1.79; 95% CI, 1.57-2.04), and an AIDS diagnosis prior to HIV therapy (HR, 1.35; 95% CI, 1.16-2.45).

Stratified analysis was then performed to see the risk factors for infection-related and non-infection-related cancers.

This showed that each year with CD4 cell count below 200 cells/mm3 increased the risk of infection-related cancers by 16% (HR, 1.16; 95% CI, 1.03-1.31).

“The risk of these malignancies is increased in immunocompromised patients, possibly because of decreased immune surveillance for oncogenic (viral) infections, as well as the presence of cancerous or pre-cancerous cells themselves,” suggest the investigators.

However, there was no relationship between immune deficiency and an increased risk of non-infection-related cancers.

The investigators conclude, “cumulative exposure to CD4+ cell counts < 200 cells/mm3 during cART was associated with an increased risk of infection-related non-AIDS-defining malignancies.”

 

Taken from Aidsmap, 20 June 2011

Posted: June 21, 2011 by Nozizwe (updated July 19, 2011)

Groundbreaking trial results confirm HIV treatment prevents transmission of HIV

WHO and UNAIDS hail results from the HPTN 052 trial that show antiretroviral therapy to be 96% effective in reducing HIV transmission in couples where one partner has HIV

GENEVA, 12 May 2011—Results announced today by the United States National Institutes of Health show that if an HIV-positive person adheres to an effective antiretroviral therapy regimen, the risk of transmitting the virus to their uninfected sexual partner can be reduced by 96%.  

“This breakthrough is a serious game changer and will drive the prevention revolution forward. It makes HIV treatment a new priority prevention option,” said Michel Sidibé, Executive Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS). “Now we need to make sure that couples have the option to choose Treatment for Prevention and have access to it.”  

The trial, conducted by the HIV Prevention Trials Network, enrolled more than 1 700 sero-discordant couples (one partner who is HIV-positive and one who is HIV-negative) from Africa, Asia, Latin America and the United States of America.   Only people living with HIV with a CD4 cell count of between 350 and 550, thus not yet eligible for treatment for their own health according to latest WHO guidelines, were enrolled in the study.

The reduction of sexual transmission of HIV was so significant that the trial was stopped 3-4 years ahead of schedule.   "This is a crucial development, because we know that sexual transmission accounts for about 80% of all new infections," said Dr Margaret Chan, WHO Director-General. "The findings from this study will further strengthen and support the new guidance that WHO is releasing in July to help people living with HIV protect their partners."  

The availability of Treatment for Prevention will not only empower people to get tested for HIV, but also to disclose their HIV status, discuss HIV prevention options with their partners and access essential HIV services. It will also significantly contribute to reducing the stigma and discrimination surrounding HIV.   “People living with HIV can now, with dignity and confidence, take additional steps to protect their loved ones from HIV,” said Mr Sidibé.  

It is currently estimated that only about half of the 33 million people living with HIV know their HIV status. An increase in the uptake of testing for HIV would have a significant impact on the AIDS response, particularly if more people gain access to treatment in light of the new findings.   UNAIDS and WHO recommend that couples make evidence-informed decisions on which combination of HIV prevention options is best for them.

UNAIDS urges that Treatment for Prevention be one of the options made available to couples. The new WHO guidelines coming out in July will help countries to make this a reality for people who choose to use this new HIV prevention option. The guidelines will include specific recommendations on increasing access to HIV testing and counseling and the use of antiretroviral therapy among discordant couples.   No single method is fully protective against HIV.

Treatment for Prevention needs to be used in combination with other HIV prevention options. These include correct and consistent use of male and female condoms, waiting longer before having sex for the first time, having fewer partners, male circumcision, and avoiding penetrative sex. The significance of the findings put Treatment for Prevention firmly in the HIV prevention package.  

To increase access to the Treatment for Prevention option, the Treatment 2.0 initiative must be urgently implemented to innovate, simplify, reduce costs and mobilize communities to scale up HIV testing and counseling and treatment.  

UNAIDS will convene a partners meeting to further discuss this new development and its implications for the AIDS response. This builds on a series of expert consultations which have been convened by WHO and UNAIDS on Treatment for Prevention during the last two years.

 

Taken from Aidsportal, 14 June 2011

 

Posted: June 14, 2011 by Nozizwe (updated July 19, 2011)

HIV treatment – changing because of side-effects

Switching from efavirenz to raltegravir leads to improvements in mood and lipid levels, new research shows.

Efavirenz (Sustiva, also in the combination pill Atripla) is a widely used anti-HIV drug that belongs to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class of antiretrovirals.

It has a powerful and long-lasting anti-HIV effect, and is generally easy to take.

Like all medicines it can cause side-effects, in particular mood and sleep problems. These are most noticeable in the first few weeks of treatment and then tend to lessen or go away. But for a small number of patients they remain a subtle, long-term side-effect. In addition, the drug has been associated with increases in cholesterol, which can increase the long-term risk of cardiovascular disease.

Raltegravir (Isentress) is a relatively new anti-HIV drug, taken twice a day, that prevents the virus from integrating with human cells. It’s the first in a class of anti-HIV drugs called integrase inhibitors.

Researchers in Switzerland wanted to see if switching from efavirenz to raltegravir was associated with a reduction in side-effects such as mood and sleep problems, as well as lipid levels.

They therefore designed a four-week study involving 57 patients taking long-term efavirenz treatment.

The patients were divided into two groups – one group changed to raltegravir, and the other continued to take efavirenz. After two weeks, each group switched to the other drug.

At the start of the study, and then after two and four weeks, the patients completed questionnaires enquiring about their mood and sleep. Blood samples were also taken to monitor lipids.

Their answers showed that patients preferred treatment with raltegravir, and over half switched to this drug at the end of the study.

Treatment with raltegravir was associated with improvements in mood, and cholesterol fell when patients were taking this drug.

“Switching to raltegravir was associated with significant improvements in anxiety and stress…and improvement in lipid profile,” conclude the authors.

You can find out more about dealing with side-effects in NAM’s booklet Side-effects. It is available on our website in English, Dutch, French, German, Hebrew, Norwegian, Polish, Russian, Spanish and Swedish.

 

Taken from HIV Weekly, 8 June 2011

Posted: June 8, 2011 by Nozizwe (updated June 22, 2011)

European approval recommended for hepatitis C drug boceprevir

The European Medicines Agency has recommended marketing approval for Merck’s hepatitis C protease inhibitor boceprevir (Victrelis), the agency announced on May 20th.

Boceprevir is the first direct-acting antiviral agent for hepatitis C to be approved in Europe. It has been approved for use by patients with hepatitits C genotype 1 and compensated liver disease in combination with the current standard treatment of pegylated interferon and ribavirin.

It has been approved for use by previously untreated patients and by patients who have failed previous therapy.

When added to standard therapy boceprevir significantly increased the cure rate in all groups of patients, with the best results seen in patients new to treatment.

Common side-effects of boceprevir treatment include anaemia, fatigue, nausea and headache.

Boceprevir is manufactured by Merck.

In the United States Merck has agreed a marketing tie-up with Roche, the manufacturer of the Pegasys formulation of pegylated interferon. Roche has agreed to promote boceprevir as part of a package of hepatitis C treatment using its well-established sales network.

Merck is also able to draw on the sales network inherited from Schering-Plough, which merged with the company in 2009. Schering Plough brought its own version of pegylated interferon, Intron A, to the partnership, but there have been some suggestions that boceprevir has performed better when dosed with the Pegasys formulation of pegylated interferon.

Boceprevir was approved by the United States Food and Drug Administration on May 13th

 

Taken from Aidsmap, 6 June 2011

Posted: June 7, 2011 by Nozizwe

US research shows importance of healthy vitamin D levels for patients with HIV

New US research has shown that vitamin D levels are associated with a number of important outcomes and markers in patients taking HIV treatment. Published in the online edition of Antiviral Therapy, investigators found that vitamin D was associated with CD4 cell count after starting antiretroviral therapy, markers of inflammation, and an important indicator of increased cardiovascular risk.

“Many of the emerging complications related to chronic HIV infection represent disease processes where vitamin D is known to play an important role,” comment the investigators.

They believe that their results are of such importance that “a randomized placebo-controlled interventional trial is crucial to determine what effect vitamin D may have on surrogate markers of CVD [cardiovascular disease], as well as on immune function and reconstitution, and to determine what vitamin D level is optimal in HIV-positive patients.”

Earlier research has already shown that vitamin D deficiency is common in patients with HIV. In addition, studies conducted in the general population have shown that low levels of this vitamin are associated with an increased risk of cardiovascular disease.

In particular, deficient levels of the vitamin have been associated with increased carotid intima-media thickness (IMT), an important indicator of hardening of the arteries, a major risk factor for cardiovascular disease. It has been suggested that this could be because the vitamin plays an important role in the inflammatory process. Furthermore, Vitamin D is also known to be involved in immune function.

Because of these findings, investigators in Atlanta undertook a study involving HIV-positive patients. It had three main aims:

• To see if vitamin D was related to makers of inflammation in HIV infection.

• To evaluate the association between the vitamin and carotid IMT.

• To examine the relationship between vitamin D and immune function.

A secondary aim was to compare these outcomes with an HIV-negative control population.

All the HIV-positive patients were aged over 18 years and had been taking antiretroviral therapy for at least six months. The study was conducted in the modern HIV treatment era – between 2005 and 2009.

A total of 149 HIV-infected patients and 34 controls were recruited. There were important differences between these two populations. Patients with HIV were older (49 vs. 38 years); were more likely to be male (85% vs. 62%); and were also more likely to be smokers (49% vs. 18%).

Patients with HIV had been living with the infection for an average of twelve years. Most (82%) had an undetectable viral load, and the average CD4 cell count was 572 cells/mm3.

Vitamin D levels were significantly higher in the HIV-negative controls (p = 0.02).

In the patients with HIV, low vitamin D levels were associated with increased inflammation (p = 0.02) and lower CD4 cell count (p = 0.04).

Vitamin D levels were also associated with the degree of CD4 cell increase since starting antiretroviral treatment, noted the investigators. They add, “the clinical implications of this finding warrants further investigation to see whether vitamin D supplementation given at the same time as initiation of ART would offer a safe and effective means of augmenting the immune restoration response to treatment.”

Low levels of the vitamin were also associated with thickening of the carotid artery (p = 0.001).

“Patients with [carotid artery] IMT levels above the median were >10 times more likely to have the lowest levels of [vitamin] D,” write the authors, “these data suggest that a high [vitamin] D level may be protective against CVD development in HIV-positive people. Studies in the general population support this finding.”

The investigators acknowledge that a limitation of their research was the small sample sizes. Nevertheless, they conclude: “our results show that vitamin D is associated with immune restoration, as well as IMT, which supports the fact that vitamin D may play a role in both HIV-related CVD and immune restoration.”

 

Taken from Aidsmap, 6 June 2011

Posted: June 7, 2011 by Nozizwe (updated June 7, 2011)

HIV-positive patients have good long-term responses to hepatitis A vaccination

HIV-positive patients have a good response to vaccination against hepatitis A virus, US investigators report in the June 15th edition of the Journal of Infectious Diseases. Overall, 85% of patients who had an initial response to the vaccination remained protected against the infection six to ten years later.

“HIV-infected adults achieve high initial seroconversion rates after hepatitis A vaccination with most initial responders maintaining seropositive responses for up to 6-10 years,” comment the investigators.

A low HIV viral load was associated with a good response to the vaccine. However, the investigators also found that overall response rates were poorer in patients with HIV than in the general population.

Hepatitis A virus can cause unpleasant, sometimes serious, symptoms and it is recommended that all patients with HIV should be immunised against the infection.

The vaccine is provided in two doses and studies conducted in HIV-negative individuals have shown that there is a 100% initial response rate, and that the vaccine continues to provide protection in the long term.

However, little is known about the long-term efficacy of the vaccine in HIV-positive patients.

Therefore, investigators from the US Military HIV Natural History Study conducted a retrospective analysis of vaccine response in 130 HIV-positive patients. The patients received the vaccine between 1996 and 2003 and were followed until 2007.

All individuals had their response to vaccine assessed after one and three years. Where available, data on longer-term responses (six to ten years) were also analysed. An antibody concentration of 10 miu/ml was considered protective against the infection.

The researchers also compared the rates of protection achieved in patients with HIV with those observed in HIV-negative.

Most (96%) of the HIV-infected patients were male, their median age was 35 years, and 51% were Caucasian. Hepatitis B co-infection was present in 9% of patients, and 2% were co-infected with hepatitis C.

When the first dose of the vaccine was provided, the patients had a median CD4 cell count of 461 cells/mm3 and 49% had a viral load below 1000 copies/ml. A total of 81 patients (62%) were taking HIV therapy, and 63% of these individuals had a viral load below 1000 copies/ml.

Twelve-months after vaccination, 89% of patients were protected against hepatitis A infection. Most (90%) of these patients were still protected after three years, and 85% still had adequate antibody levels after six-to-ten years.

Individuals with a CD4 cell count above 350 cells/mm3 at the time of vaccination were more likely to have an initial response than those with lower CD4 cell counts (94% vs. 78%, p = 0.006). Response rates for individuals with a CD4 cell count of 350 cells/mm3 or above were still higher (but not significantly so) after three years (95% vs. 87%), but there was no difference in response according to CD4 cell count in the longer term.

For patients who had an initial response, mean antibody levels at years one, three, and six-to-ten were 154, 111, and 64 miu/ml respectively.

Further analysis showed that a viral load below 400 copies/ml was associated with higher antibody concentrations in the long term (p = 0.02)

A CD4 cell count above 350 cells/mm3 and a viral load below 1000 copies/ml were associated with more robust concentrations of antibodies at all time points. Moreover, further analysis showed that a viral load below 400 copies/ml was associated with higher antibody levels in the long term (p = 0.02).

However, antibody concentrations were lower in HIV-positive patients than in the HIV-negative controls, all of whom had an initial response to the vaccination.

“Given the lower initial antibody levels and increasing life expectancy of HIV-infected persons, postvaccination booster doses may be necessary to maintain anti-hepatitis A virus levels  > 10 miu/ml over time (ie, > 10 years),” write the authors.

They conclude, “maintaining suppressed HIV RNA levels among HIV-infected persons may be an important strategy for sustaining durable antibody levels for vaccine preventable infections such as hepatitis A virus.”

 

Taken from Aidsmap, 6 June 2011

Posted: June 7, 2011 by Nozizwe

UK government issues global HIV spending statement

The United Kingdom government has issued a new policy statement on global  HIV spending, saying it will target HIV funding up to 2015 towards prevention, with its main focus on countries with a high burden of HIV in southern Africa.

The Department for International Development statement also promises continued support for the scale-up of access to diagnosis, treatment, care and support, chiefly through the Global Fund to Fight AIDS, Tuberculosis and Malaria.

The position paper emphasises the UK commitment to reducing rates of infection among women and girls, who are disproportionately affected by HIV in sub-Saharan Africa. DFID says it will work towards reducing new infections by 500,000 among women and key populations in at least six countries by 2015.

UK support will also be targeted towards prevention of mother to child HIV transmission, intensified action to improve rates of case detection for tuberculosis in people with HIV infection and improved completion rates for TB treatment in people with HIV. Tackling tuberculosis is much more strongly emphasised in the new UK position paper than in previous DFID policy statements on HIV.

DFID says that its responses to HIV are grounded in the principles of `know your epidemic` and `know your response`. It wants to see a greater emphasis on scaling up interventions that are known to work, and which match the local profile of the epidemic. DFID says it is “concerned by the lack of progress in developing effective prevention programmes, particularly in achieving and sustaining behaviour change by vulnerable groups”, but makes no promises about funding for prevention research.

On treatment, the position paper admits a global failure to reach the target for universal access to prevention, treatment and care by 2010, but says that the UK remains committed to the goal of universal access.

The UK will increase its funding to the Global Fund to Fight AIDS, Tuberculosis and Malaria, but the sum it will give will not be announced until later in 2011. The UK gives a high rating to the efficiency of the Global Fund, and will continue to channel most of its funding for HIV and TB treatment through the fund. But DFID says it wants to see the Fund support more prevention work.

DFID says its support to the Global Fund between now and 2015 will support treatment for 268,000 people at current prices, and it hopes that funding the work of the Clinton Health Access Initiative to drive down the costs of antiretroviral drugs will allow an extra 500,000 people to be treated by 2015.

DFID will also continue to support UNITAID, the international drug purchase fund, and will press pharmaceutical companies to support the Medicines Patent Pool, which is designed to produce cheap and innovative drug combinations for HIV treatment.

Bilateral funding will focus on Burma, Cambodia, Democratic Republic of Congo, India, Kenya, Malawi, Mozambique, Nepal, Nigeria, South Africa, Uganda, Vietnam, Zambia, Zimbabwe, and on regional programmes in Africa, Central Asia and the Caribbean.

The United Kingdom governments says it will also continue to advocate at national and international level for the needs of vulnerable populations, particularly those neglected by national responses, such as injecting drug users, men who have sex with men, sex workers and prisoners.

At country and regional level the UK will fund scale-up of harm reduction in Central Asia, services for vulnerable populations in the Caribbean.

The position paper does not mark a significant departure from commitments made in a 2008 policy statement under the previous Labour government, but does contain more explicit targets for the results UK spending is intended to achieve.

 

Taken from Aidsmap, 6 June 2011

Posted: June 7, 2011 by Nozizwe

30 years of AIDS: remembering how it began - from those who were there

Sunday June 5 sees the 30th anniversary of the first reports of the disease that later came to be known as AIDS.

At the time no one could have anticipated the scale of the epidemic that was about to emerge, or the global significance of the cases that were being reported among young gay men in California and New York.

The emergence of the epidemic was a shocking, epochal event, and it had a devastating impact on gay communities and injecting drug users in North America.

But it was the responses of the communities affected, and of the medical professionals who cared for the first people diagnosed with AIDS, that set the tone for the global response to AIDS for the next 30 years.

It was a response emphasising human rights, compassion, solidarity, activism and generosity, and without it, the global epidemic of HIV and AIDS might have been handled in a much more punitive and authoritarian manner.

Therefore, we have chosen to commemorate the 30th anniversary of the first case report by collecting together resources that illuminate the early days of AIDS.

The links below will lead you to testimony from people who lived through the early years of the epidemic, many of them central to the early responses in the gay communities of North America.

The first report of AIDS cases – Pneumocystis pneumonia in five young men, June 5 1981. The first case report.

A Cluster of Kaposi's Sarcoma and Pneumocystis carinii Pneumonia among Homosexual Male Residents of Los Angeles and Orange Counties, California, June 18, 1982; the first strong endorsement for the view that AIDS was caused by a sexually transmitted agent.

We Were Here –an award-winning documentary on the early years of AIDS in San Francisco and the city’s response.

The History of AIDS: Emergence and Origins of a Modern Pandemic, by Mirko Grmek. Still the best book on the early history of the epidemic, now available in large portions through Google Books to read online.

Gay Men’s Health Crisis: Dr Lawrence Mass, one of the six founders of Gay Men’s Health Crisis, New York’s first AIDS organisation, reflects on the origins of the organisation in the activism of its six founders.

AIDS begins to emerge in new populations: Dr John G. Bartlett looks back at the emergence of AIDS in injecting drug users in Baltimore, and his efforts to establish a clinic to provide care at Johns Hopkins University.

How to Have Sex in an Epidemic: the first safer sex advice, authored in May 1983 by New York activists Richard Berkowitz and Michael Callen. The leaflet set the tone for gay community responses to safer sex worldwide. You can also watch an interview with Richard Berkowitz and Dr Joe Sonnabend, their medical adviser, about the origins of safer sex advice, on YouTube from Jean Carlomusto’s film Sex in an Epidemic.

San Francisco AIDS Foundation: a video on the impact of AIDS in San Francisco since 1981 and the civic and political response to AIDS in the city.

The San Francisco AIDS Oral History Series:  a unique archive of interviews with people involved in the early years of AIDS in San Francisco; the sequence of interviews on the medical responses is available here.

      Taken from Aidsmap, 6 June, 2011

Posted: June 7, 2011 by Nozizwe (updated June 22, 2011)

HIV testing radio campaign among African communities in London

The African Health Policy Network (AHPN), Terrence Higgins Trust (THT) and HEAL have jointly launched a radio campaign to promote HIV testing among African communities in London.

The adverts are currently being broadcast on Choice FM, BANG FM and Voice of Africa Radio giving listeners useful information about testing services and capturing the experiences of people who have taken the test. The campaign aims to increase HIV diagnosis by linking listeners to the confidential African helpline 0800 0967 500. To listen to the adverts, which are being aired eight times a day, please tune in to:

• Choice FM 107.1FM and 96.9FM

• Voice of Africa Radio 94.3FM

• Bang Radio 103.6FM

• Until the end of June

 

The campaign started only a few weeks ago and we have already seen a huge increase in the number of people calling the African helpline number 0800 0967 500.

So please do tune in and listen and encourage your contacts to do so as well!!! 5 extended versions of the adverts will also be available to download as mp3s on the mambo website www.mambo.org.uk  from the 31st June 2011.   

The campaign is funded through the Pan London HIV Prevention Programme. For more information about the campaign, please contact abigail.okunlola@ahpn.org or joseph.ochieng@tht.org.uk

Posted: June 6, 2011 by Nozizwe (updated July 19, 2011)

Treatment as prevention works!

 UNAIDS says finding is 'serious game changer' for HIV prevention

A large randomised study of treatment as prevention has closed more than three years early after interim analysis of the data showed that antiretroviral treatment reduced the risk of HIV transmission from treated partner to uninfected partner by 96%.

 

The magnitude of the reduction in risk is almost the same as that observed in multiple cohort studies in sub-Saharan Africa, and is the strongest effect seen in any trial that has used an antiretroviral-based prevention method.

HPTN 052 is a large, international study which randomised 1736 male-female couples in which one partner was HIV-positive either to begin antiretroviral therapy immediately, or to wait until treatment was clinically indicated (at a CD4 count of 250 cells/mm3).

The study began enrolling participants in 2005 in Botswana, Brazil, India, Kenya, Malawi, South Africa and Zimbabwe, and recruited couples in which the HIV-positive partner had a CD4 cell count between 350 and 550 cells/mm3. The median CD4 count at the time of joining the study was 436 cells/mm3. This level is higher than the threshold at which World Health Organization guidelines currently recommend starting treatment.

The study was due to run until 2015.

The study was halted after an interim review by the Data and Safety Monitoring Board, which found that 39 infections had occurred. Twenty-eight could be genetically linked to the HIV-positive partner, and of these 27 occurred in couples where the HIV-positive partner did not begin antiretroviral therapy immediately. This translates into a 96% reduction in the risk of transmission. This result was highly statistically significant (P<0.0001).

All participants received regular counselling on safer sex, free condoms and treatment for sexually transmitted infections.

The results of HPTN 052 show that treatment of people with relatively high CD4 cell counts results in very substantial reduction in the risk of HIV transmission.

The study also found a statistically significant reduction in the risk of extrapulmonary tuberculosis in the early treatment arm: 17 cases occurred in the deferred treatment arm, compared to 3 cases in the early treatment arm (p=0.0013).

There was not a significant difference in the death rate, however: 13 deaths occurred in the deferred treatment arm and ten in the immediate treatment arm. There were 105 morbidity and mortality events: 65 events in the delayed treatment arm and 40 in the immediate treatment arm.

Reactions

Coming just ahead of the UN General Assembly Special Session on AIDS early next month in New York, these results are likely to give a powerful boost to messages that greater investment in HIV treatment could have a significant impact on the growth of the epidemic

“This breakthrough is a serious game changer and will drive the prevention revolution forward. It makes HIV treatment a new priority prevention option,” said Michel Sidibé, Executive Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS). “Now we need to make sure that couples have the option to choose Treatment for Prevention and have access to it.”

“People living with HIV can now, with dignity and confidence, take additional steps to protect their loved ones from HIV,” said Mr Sidibé.

 “The upcoming UN High Level Meeting on AIDS should set treatment and prevention targets that take the HPTN 052 results into account,” said Mitchell Warren of AVAC, an organisation which advocates for new HIV prevention technologies. “We need to start critical discussions and come to quick decisions about where and how to deploy treatment as prevention in the short-term. Government and international normative agencies now have a critical mass of data to publish guidelines for appropriate implementation of treatment as prevention in concert with other prevention methods.”

“Today's result should be viewed in light of other recent findings from trials using ARVs for prevention,” said Mitchell Warren. “The recent results from the iPrEx trial showed that PrEP is effective in gay men and transgender women, while the CAPRISA 004 microbicide trial showed that 1% tenofovir gel is effective at reducing HIV risk for women.”

 “Together, these results allow us to imagine a world in which men and women seek HIV testing with the knowledge and confidence that they will receive a range of highly effective options for staying healthy and protecting themselves and their partners—whatever the test result," Warren added.  “The results of the study require us to rethink how we structure the delivery and funding of HIV services overall.“

 

Taken from Hatip, 2 June 2011

 

Posted: June 6, 2011 by Nozizwe (updated June 22, 2011)

HIV and hepatitis C

A genetic mutation is associated with an increased risk of cirrhosis for patients co-infected with HIV and hepatitis C, according to Spanish research published in the June 1st edition of the Journal of Infectious Diseases.

Carriage of the IL28B gene was the single biggest risk factor for cirrhosis, possibly explained by its association with long-term disturbances in liver function.

Paradoxically, earlier research has shown that individuals who carry the gene are more likely to spontaneously clear hepatitis C infection and respond to interferon-based therapies.

Indeed, it was this relationship between the gene and improved outcomes that prompted investigators in Madrid and Andalusia to carry out a retrospective study to assess the gene’s association with cirrhosis.

The study involved 304 co-infected patients.

FibroScan, a non-invasive test that assesses liver stiffness, was used to assess the patients’ fibrosis stage. In addition, blood tests were used to monitor patients for the presence of the IL28B gene, and to determine hepatitis C genotype, liver function, and HIV-related parameters.

Participants had a mean age of 43 years, 80% were male, 86% were former injecting drug users, and 19% had a history of alcohol abuse. None of the patients had received hepatitis C therapy.

Most patients (85%) were taking antiretroviral therapy, and 79% had an undetectable HIV viral load. The mean CD4 cell count was 552 cells/mm3.

Abnormal liver function was common, and 72% of patients had ALT levels above the upper limit of normal. Mean hepatitis C viral load was 6.12 log10 copies iu/ml, and 68% had a level above 600,000 copies iu/ml. The harder to treat hepatitis C genotypes (1 and 4) were present in 68% of patients.

Cirrhosis was diagnosed in 18% of individuals. However, none of the patients had decompensated liver disease.

The IL28B gene was present in 46% of patients. Patients carrying this gene had significantly lower mean CD4 cell counts (518 vs 581 cells/mm3; p = 0.04), and there was also a trend for them to have higher mean ALT levels (93 vs 82 iu/ml; p = 0.14). Moreover, in the five years before baseline analysis, mean ALT levels were significantly greater in the IL28B carriers than other patients (p = 0.01).

FibroScan tests showed that liver stiffness values were significantly greater in carriers of the gene (p < 0.05), and these patients were also significantly more likely to have cirrhosis than non-carriers of the gene (24 vs 13%, p = 0.01).

In addition, patients with cirrhosis were also significantly older (43 vs 41 years; p = 0.04), had longer duration of hepatitis C infection (25 vs 23 years; p = 0.03), and were marginally more likely to have a history of alcohol abuse (28 vs 17%; p = 0.06).

Regardless of the hepatitis C genotype with which a patient was infected, the IL28B gene was associated with a greater prevalence of cirrhosis  (genotype 1: 28 vs 15%, p = 0.04; genotype 3: 22 vs 6%, p = 0.04; genotype 4: 18 vs 15%).

Statistical analysis that controlled for potential confounders showed that carriage of the IL28B gene was the single most important risk factor for the development of cirrhosis (odds ratio [OR] = 2.32; 95% CI, 1.22 to 4.41; p = 0.01).

By contrast, the association with older age (p = 0.08) and prior alcohol abuse (p = 0.07) was only of borderline significance.

Further analysis showed that patients carrying the IL28B gene developed cirrhosis more frequently and within a shorter duration of time than other individuals (hazard ratio = 3.02; 95% CI, 1.24 to 7.39; p = 0.015).

“HIV-HCV-coinfected patients carrying the IL28B…genotype are at greater risk of developing liver cirrhosis,” conclude the investigators; “enhanced immune-mediated damage in the liver of chronically HCV-infected persons who harbour the genotype could hypothetically explain these findings.”

 

Taken from HIV Weekly, 1 June 2011

Posted: June 2, 2011 by Nozizwe (updated June 22, 2011)

HIV and sexual health – superinfection

Dutch researchers have failed to find any evidence of HIV superinfection in HIV-infected gay men who had unprotected sex.

Superinfection (often called reinfection) involves infection with a second strain of HIV. Risk factors for superinfection appear to be the same as those for initial infection with HIV, especially unprotected anal or vaginal sex.

Many HIV-positive people choose to have unprotected sex with other people with HIV – this is often called serosorting.

About 50 cases have been reported in the medical literature. However, there’s disagreement about how common it really is. Some researchers think it is very rare, but others believe much more common than the small number of case reports suggests.

Researchers in Amsterdam wanted to gain a better understanding of this important question.

The research involved 15 HIV-positive gay men. They had blood tests every three months to check for superinfection. Every six months they were asked if they had had unprotected anal sex, or if they had been diagnosed with a sexually transmitted infection (STI).

All the men had either reported unprotected anal sex with two or more partners, or were diagnosed with a STI, in at least one six-month period.

The men were monitored for an average of 5.8 years.

No superinfections were detected.

However, the researchers do not regard their results as definitive and call for further studies into this matter. In particular, they speculate that the level of risk of the men in their study may not have been high enough to lead to superinfection.

But the research envisaged by the researchers may be difficult to conduct, especially because of the criminalisation of HIV transmission, or of non-disclosure of infection status, in many countries.

This means that men may be disinclined to provide frank information about their sexual behaviour, even where the inquiry relates to sexual behaviour with partners of the same HIV status.

 

Taken from HIV Weekly, 1 June 2011

Posted: June 2, 2011 by Nozizwe (updated June 22, 2011)

HIV and health monitoring – CD8 cell count

New research shows that a high CD8 cell count is associated with poorer HIV treatment outcomes.

CD8 cells are immune system cells. They play an important part in controlling untreated HIV infection. However, in people not taking HIV treatment, an elevated count has been associated with faster disease progression.

Researchers from the US military wanted to see if a high CD8 cell count was also associated with HIV treatment outcomes.

They monitored 817 patients who started HIV therapy between 1996 and 2008. A CD8 cell count above 1200 was regarded as elevated.

All the patients had an undetectable viral load one year after starting treatment, and during this time, average CD8 cell count fell by 61.

But in the longer term, a higher CD8 cell count was associated with poorer outcomes, especially for patients who started HIV treatment after 2000.

Average CD8 cell count increased in patients whose viral load became detectable, but fell among patients who maintained an undetectable viral load.

“We found that elevated total CD8 cell counts were associated with greater risk of future virologic failure,” comment the researchers.

They believe their findings have significance for routine HIV care, commenting: “An elevated CD8 count may be one of the few indicators of future virologic failure among virally suppressed individuals who may not otherwise be viewed as at high risk of failure.”

 

 

Taken from HIV Weekly, 1 June 2011

Posted: June 2, 2011 by Nozizwe

HIV treatment – factors affecting treatment outcomes

 

Researchers in the US have found that the immune systems of people aged 50 and over recover less well than those in younger people once they start HIV treatment. They recommend that earlier treatment should be a priority in this group.

The study looked at a range of factors associated with longer-term outcomes of HIV treatment. Researchers thought that age, people’s health before starting treatment, and CD4 count and viral load during the first five years of treatment, would affect responses in the longer term.

Researchers looked at the response to treatment in 614 men who had been on treatment for five to twelve years.

In the first five years of treatment, all the participants had significant increases in their CD4 count, whatever it had been on starting treatment. But people whose CD4 count was under 350 on starting treatment had poorer increases, as did people who were co-infected with hepatitis B.

People who had an undetectable viral load for at least half of the first five years on treatment had higher CD4 cell counts in the longer term, as did those individuals who stayed on their first or second combination of drugs.

Age at starting treatment seems to predict longer-term outcomes: average CD4 counts were lower in men who started treatment aged 50 or over, compared to people who started under 40. To achieve a similar long-term CD4 cell count as the under 40s, older patients would have needed to start treatment when their CD4 cell count was above 350 cells/mm3.

People who had taken all their treatment exactly as prescribed (often called adherence) did well on treatment.

Encouragingly, even with variations in outcomes, the findings of the study show that HIV treatment works well in the longer term. The majority of people had a CD4 cell count above 500 cells/mm3 after five or more years of treatment and 75% of them had an undetectable viral load.

 

Taken from HIV Weekly, 1 June 2011

Posted: June 2, 2011 by Nozizwe

HIV care – online HIV clinic

Spanish researchers have found that some patients can safely receive almost all their HIV care online.

The research was conducted in Barcelona and involved patients whose HIV infection was stable.

Doctors were concerned that increases in the numbers of HIV-positive patients were placing a strain on clinics.

Visits for routine appointments can also be inconvenient for patients. They usually involve seeing a doctor, nurse and pharmacist and can last up to two hours.

Therefore researchers wanted to see if care could be delivered effectively and safely via an online ‘Virtual Hospital.’

Patients had an online consultation with their doctor and pharmacist, and medicines were mailed directly to their home address.

Other healthcare professionals, such as psychologists, were also available to give online support.

Outcomes for patients using the Virtual Hospital were just as good as those for patients using traditional clinic services.

Some patients safely started or changed HIV treatment using online support.

The Virtual Hospital was rated as satisfactory, and its running costs were quite low.

Online support looks like a promising development as one element of HIV care.

Many patients in the UK already keep in contact with their doctor using email, and it can save time (and money for the NHS) to have home delivery of your anti-HIV drugs.

 

Taken from HIV Weekly, 25 May 2011

Posted: May 25, 2011 by Nozizwe

Community-based testing increased rates of HIV testing and detection in resource

HIV testing rates in rural areas of resource-limited countries can be substantially increased using an intervention that involves community-based testing, mobilising targeted communities, and the provision of post-testing support, investigators report in The Lancet Infectious Diseases.

The intervention was associated with testing rates that were up to nine times higher than those achieved by standard voluntary counselling and testing (VCT) services, and led to the diagnosis of more cases of HIV.

“Bringing VCT directly to communities and linking VCT with mobilisation efforts and support services after HIV testing results in substantially greater uptake of both HIV testing and case detection than does standard voluntary counselling and testing,” write the investigators.

The study – called Project Accept – was undertaken because of the high rates of undiagnosed HIV infection in many resource-limited settings.

Investigators wanted to see if community-based HIV testing combined with community mobilisation and good post-testing support increased the number of individuals coming forward for screening.

They therefore designed a study involving communities in Tanzania (ten communities in Kisarawe District), Thailand (14 communities in Chiang Mai Province), and Zimbabwe (eight communities in the Mutoko District).

Communities in each of these regions were randomised to receive the community-based intervention or standard VCT services, based at a clinic or health centre. The study was conducted between 2006-09.

Investigators wished to see if the intervention was associated with higher rates of testing, the diagnosis of more cases of HIV, and an increased likelihood of repeat testing. Their current analysis was limited to individuals aged 16 and 32 years. This was because of this age group’s high risk of HIV and low testing rates.

In each of the regions, the proportion of individuals receiving their first HIV test was higher in the districts that received the community-based intervention than those using standard VCT (Tanzania: 37% vs. 9%; Thailand: 69% vs. 23%; Zimbabwe 51% vs. 5% - all p < 0.001).

“We believe that the CBVCT [community based VCT] strategy achieved HIV testing in an average of 55% of community residents aged 16-32 years across the three sites because of the multicomponent, comprehensive, and integrated nature of the intervention,” comment the investigators.

They add: “Ease of access for HIV testing services has a major effect on uptake” and suggest “both community mobilisation and social networking dynamics promoted uptake of HIV testing in CBVCT communities.”

However, testing rates for couples were higher at standard VCT centres. The investigators suggest that this is because of their linkage with antenatal services.

HIV prevalence rates were lower at the community-based sites (Tanzania 4% vs. 7%; Thailand: 2% vs. 3%; Zimbabwe 13% vs. 22% - all p < 0.001). Nevertheless, because of the community sites tested more people, they detected more HIV infections than the standard VCT sites (952 vs. 264, p = 0.003).

Rates of repeat HIV testing at the community-based sites were high and increased during the study reaching 28%.

The investigators believe that the benefits of community-based VCT extend beyond increasing the number of tested individuals and HIV cases diagnosed, and could help combat the stigma the surrounds HIV.

“As increasing numbers of people learn their serostatus, an untested person is more likely to personally know someone who has tested, instilling trust in the safety and benefits of learning their serostatus.”

Furthermore, high rates of repeat testing at community services could benefit HIV prevention.

“As a CBVCT programme matures, the epidemiological benefits…also evolve from case detection towards behavioural reinforcement and prevention.”

They conclude: “Within a short period, Project Accept mobilised large proportions of the study population to go through the difficult process of learning their HIV infection status, proving that local communities respond to HIV epidemics when comprehensive, user-friendly services are provided.”

 

Taken from Aidsmap, 23 May 2011

Posted: May 23, 2011 by Nozizwe

Local beliefs and ART programme factors both influence late ARV starts in sub-Sa

Late treatment initiation in HIV clinics in sub-Saharan Africa is being influenced by numerous factors, and there is no single `quick fix` that will improve the situation, researchers from the International Center for AIDS Care and Treatment Programs report in the journal AIDS.

They found that factors relating both to the service design and to the population of the district in which a clinic provided care played important parts in determining the risk of late treatment initiation.

An estimated 44% (5 million) people in need of treatment in sub-Saharan Africa are now on ART, up from approximately 100,000 in 2003.

One of the greatest challenges remains getting people into care and onto treatment early. Too many are accessing treatment at an advanced stage of their illness (at very low CD4 cell counts).  In resource-poor settings there is a 3-4 fold higher death rate in the first year on ART compared to outcomes in resource-rich settings. Not only does this severely limit the potential of ART, it also adds to already overburdened health care systems, increases costs and misses potential opportunities for HIV secondary prevention.

The authors looked at quarterly aggregate monitoring and evaluation indicator data from ICAP / Columbia University-supported HIV care clinics in eight sub-Saharan African countries: Ethiopia, Kenya, Lesotho, Mozambique, Nigeria, Rwanda, South Africa and Tanzania. Cohort information from the 267 sites was combined with updated programme level data from site surveys in accordance with the date the cohort started ART and with national contextual-level information from Demographic and Health Surveys (DHS).

The data were analysed using three multivariate models: only programme-level factors, only contextual-level factors and a combination of programme and contextual factors significant in the first two models.

For the purposes of measuring late initiation centres – and chronological cohorts within those centres, in order to capture changes in service delivery   – were classified according to the median CD4 cell count at treatment initiation. A low median cell count was classified as one below 111 cells/mm3. Across all 1690 cohorts starting ART the median CD4 cell count at treatment initiation was 136 cells/mm3.

Multivariate analysis showed that the specific factors associated with late initiation were:

• No PMTCT affiliation (AOR: 3.6; 95% CI: 1.0-12.8) [indicative of a delayed diagnosis after infection];

• Lower level of AIDS knowledge [indicative of willingness to engage in care after an HIV diagnosis] and lower uptake of HIV testing in the district;

•  The availability of outreach services for ART patients only, compared to availability for both pre-ART and ART patients (AOR:2.4; 95% CI: .5-3.9); fewer compared to more adherence support services (AOR: 1.6; 95% CI:1.0-2.5), lower provider to patient ratio (AOR: 2.2; 95% CI: 1.3-4.0)[a delayed ART start once in care]

The high rates of late ART start in the region were programme-specific and independent of the site characteristics.

The study also found that a high local prevalence of the belief that “limiting themselves to one HIV-uninfected sexual partner reduces HIV risk” was associated with a high risk of late treatment initiation (AOR 1.09 per unit increase in belief prevalence, 95% CI 1.06-1.11).

The authors suggest this finding could reflect either a false sense of security among the undiagnosed or “reverse causality”, that is HIV prevention efforts take place in areas where HIV death and illness are the highest.

The authors note their findings highlight the need when designing HIV treatment programmes to further understand the reasons why ART is started late (late diagnosis, late engagement into care, and delayed ART start after confirmation of eligibility).

The risk of starting ART at a low CD4 cell count decreased over time. The authors suggest this may be because of increased HIV testing uptake and ART availability. However, they note this is not necessarily the case.

They cite studies from the United States that found high rates of late diagnosis, delayed enrolment into care and so late ART initiation. An estimated 26% of people in the United States (and New York City) are diagnosed with AIDS at the same time as their HIV diagnosis.

The authors caution that in sub-Saharan Africa “without substantial expansion in HIV testing, increased efforts at engagement in care, close clinical and immunological monitoring for ART eligibility, the challenge of late ART start may well persist.”

Strengths of the study include the use of routinely collected aggregate data used for monitoring and evaluation. Data were gathered from a wide variety of sites including rural and small sites without electronic data systems so increasing the generalisability of their findings.

Sensitivity analyses supported the strength of the findings.

The authors note that because their study was observational rather than randomised there is a possibility of confounding.

Data quality in the service delivery context is often limited and may have influenced the results.

The analysis included rural sites, however only 15% of patients were from rural sites so limiting the generalisation of the findings.

The authors conclude “structural interventions targeting points from the start of ART along the continuum from infection to diagnosis to care are needed.”

 

Taken from Aidsmap, 23 May 2011

Posted: May 23, 2011 by Nozizwe

Janssen issues warning on potential non-toxic contamination of Prezista 400mg

Janssen, the manufacturer of the HIV protease inhibitor Prezista (darunavir), has issued a warning to pharmacists and patients regarding the potential contamination with wood preservative of approximately 2000 bottles of Prezista 400mg or 600mg tablets supplied to five countries.

If patients notice a musty, mouldy smell when handling or opening a bottle of Prezista 400mg or 600mg tablets they are asked to contact their HIV pharmacist immediately, but not to stop taking the medication. Alternatively patients in the United Kingdom may contact Janssen on 0800 032 3013.

In the United Kingdom the problem is linked only to 400mg tablets.

The problem is caused by a chemical called TBA which is present in wood preservative, and which has been detected in 'trace amounts' in a small number of bottles. The chemical contamination is thought to have come from wood pallets on which goods are transported and stored, and is related to batches handled by one supplier.

Four patients taking Prezista have reported temporary gastrointestinal symptoms which may be related to exposure to the chemical.

As a precaution, Janssen has recalled five batches of Prezista 400mg or 600mg tablets supplied to pharmacies in the United Kingdom, Ireland, Germany, Austria and Canada, all of which were handled by the same supplier.

The recall does not apply to Prezista 75mg, 150mg and 300mg tablets.

 

Taken from Aidsmap, 23 May 2011

Posted: May 23, 2011 by Nozizwe (updated June 22, 2011)

South African women with AIDS conspiracy beliefs half as likely to use condoms

In Cape Town, African women who think that AIDS is man-made are half as likely as other African women to have used a condom during their most recent sexual encounter, researchers report in the journal AIDS and Behavior. In addition, African men who believe that HIV is harmless while antiretroviral drugs are harmful are half as likely to use condoms as other men.

There are important differences in the findings for men and women, which suggests that gender is crucial to understanding AIDS conspiracy and denialism in South Africa.

A previous ethnographic study has also found that the attribution of blame for HIV and AIDS expressed the different concerns of men and women. Women’s accounts centred on the domestic context, whereas men - who had had greater exposure to international economic and political forces beyond their control - tended to blame more distant agents such as scientists, governments, soldiers and Americans.

For the current study, Eduard Grebe and Nicoli Nattrass analysed responses to the 2009 Cape Area Panel Study, a cross-sectional survey of young adults aged 19 to 29 in metropolitan Cape Town. They believe their sample is broadly representative of urban Africans and coloureds of the age group in this area.

A total of 2,901 individuals took part, 45% of whom were described as African, 49% as coloured and 5% as white.

Respondents were asked if they agreed or disagreed with three statements associated with AIDS conspiracy beliefs - that AIDS was invented to kill black people, that AIDS was created by scientists in America and that AIDS was deliberately created by humans. Individuals who agreed with more than one statement were considered to have AIDS conspiracy beliefs.

Whereas only 2.6% of non-Africans held conspiracy beliefs, one in five (19.7%) of young adult Africans did so.

The rest of the results we report only concern the 735 African women and 578 African men in the sample. Moreover, they are statistically significant results from multivariate analysis, which is adjusted for confounding factors.

Among African women, holding conspiracy beliefs was associated with lower levels of education and lower household income, but there was no clear association with employment or age. Members of religious organisations were half as likely to have conspiracy beliefs as other women.

However women who had scored highly for psychological distress (frequent experience of nervousness, hopelessness, worthlessness, depression etc) were twice as likely to hold conspiracy beliefs as other women (odds ratio 2.52, 95% confidence interval 1.33 - 4.76).

There were very strong correlations between beliefs in witchcraft, beliefs in the importance of initiation rituals for men and AIDS conspiracy beliefs.

Women who had never heard of the Treatment Action Campaign (a group which has campaigned vigorously against conspiracy theories) were three times as likely as others to hold conspiracy beliefs. On the other hand, women who often got news from TV, radio or newspapers were actually more likely to hold conspiracy beliefs than others.

Whereas the researchers identified a number of factors that are associated with women holding conspiracy beliefs, the picture is less clear-cut for African men. For the majority of the factors previously cited, there were no statistically significant associations between the factors and having conspiracy beliefs.

However the association with psychological distress was equally important (odds ratio 3.01, 95% confidence interval 1.41 - 6.41).

And whereas women who got news from the TV, radio or newspapers tended to hold conspiracy beliefs, men using the media are less likely to hold these beliefs.

 

Taken from Aidsmap, 23 May 2011

Posted: May 23, 2011 by Nozizwe

Diet, exercise and cancer screening boosted by 'highly feasible' intervention

Fruit and vegetable consumption and exercise frequency can be increased by participation in a health promotion intervention designed to reduce the risk of chronic diseases, investigators report in the April 25th edition of the Archives of Internal Medicine.

The research involved African-American HIV-serodiscordant heterosexual couples who were randomised to receive either information and motivation about the benefits of good diet and exercise, or a general HIV/sexual health promotion intervention.

Up to a year after completing the programme, couples participating in the healthy living intervention were significantly more likely to report eating a diet rich in fresh fruit and vegetables and regular exercise.

Moreover, participation in the enhanced health promotion information was associated with the consumption of less fatty food, and increased rates of screening for prostate and breast cancer.

“The present results demonstrate that a health promotion intervention had significant effects on multiple health behaviors in African-American HIV-positive and HIV-negative individuals,” comment the investigators. The author of an accompanying editorial was “particularly impressed with the intervention.”

Chronic conditions such as cardiovascular disease are now an important cause of illness and death in people with HIV. Therefore, addressing modifiable risk factors for such illnesses is now an important priority of HIV care.

African-Americans represent 48% of all HIV-positive patients in the US, and African-Americans generally eat fewer fruit and vegetables, exercise less frequently, and have poorer survival rates for prostate and breast cancer than white Americans.

Investigators therefore wished to see if an intervention could improve a range of health behaviours in HIV-serodiscordant African-American couples enrolled in an HIV/sexual health promotion study.

The study was conducted between 2003 and 2007. The intervention consisted of eight two-hour weekly sessions and was designed to build skills and knowledge about eating lots of fruit and vegetables, exercise, the reduction of fat in diet, screening for prostate and breast cancer, and alcohol use.

A total of 550 individuals were randomised to receive the intervention, and 520 individuals were randomised into a control arm, and received HIV/sexual health information. Outcomes were monitored six and twelve months after completion of the trial.  

At baseline, only 21% of participants overall reported eating five or more portions of fruit and vegetables a day, and fewer than 20% exercised regularly.

Six and twelve months after completing the study, individuals in the intervention arm were 38% more likely than those in the control arm to report having a diet that incorporated large amounts of fruit and vegetables (odds ratio [OR] = 1.38; 95% CI, 1.18-1.62, p < 0.001). Patients in the intervention arm were also significantly less likely to report the consumption of fatty foods (p = 0.003).

They were also 39% more likely to report regular exercise (OR = 1.39; 95% CI, 1.22-1.59, p < 0.001).

Rates of prostate and breast cancer screening were also significantly higher in the intervention arm (p < 0.001 and p = 0.009 respectively).

However, alcohol consumption was comparable in the two arms of the study. The investigators speculate that this was because individuals in the control arm received information about the role of alcohol in HIV risk behaviour.

“We are optimistic that the present study offers an approach that may help reduce the disproportionately high morbidity and mortality rates from chronic diseases in African-Americans,” conclude the authors.

In his accompanying editorial, Dr Mitchell H. Katz of the Los Angeles Department of Health described the intervention as “highly feasible”, adding that although it was conducted in serodiscordant couples, “there is no reason to believe that [the] intervention would not work among HIV-infected persons.”

 

Taken from Aidsmap, 23 May 2011

Posted: May 23, 2011 by Nozizwe (updated May 26, 2011)

High levels of mental distress, unprotected sex, needle sharing, unmet preventio

Risky sex and drug use are common among HIV-positive individuals in Russia, investigators report in AIDS and Behavior. Discrimination was a common experience, and there was a high prevalence of depression and anxiety.

“Policies and public health programs for PLH [people living with HIV] need to focus on comprehensive strategies to address continuing transmission risk behaviors as well as improve…psychological well-being [and] social circumstances,” comment the study’s authors.

Russia has one of the fastest growing HIV epidemics in the world, and it is estimated that as many as 940,000 individuals in the country (1.1% of the population) are HIV-positive.

However, little is known about the transmission risk behaviours, mental health characteristics, and levels of adherence to antiretroviral therapy among Russia’s HIV-positive patients.

St Petersburg is an epicentre of the epidemic in Russia, and in 2008-09 investigators from the city conducted a cross sectional study that included 492 HIV-positive adults.

These patients completed questionnaires enquiring about their demographics, disclosure of HIV, experience of perceived discrimination, sexual and drug use behaviour, use of HIV therapy and adherence, and mental health.

The patients had a mean age of 30, and 53% reported they were in employment. The overwhelming majority (86%) reported that they were exclusively heterosexual, and the patients had been living with diagnosed HIV infection for a mean of 58 months.

There were high rates of disclosure to family members (80%), close friends (76%), or other people with HIV (68%).

However, reported discrimination was common. A fifth of patients reported that they had been tested for HIV without their consent. Moreover, a quarter of patients reported that they had been refused medical care, including 9% who said that they had been refused general health care because of their HIV status. In addition 12% of individuals said that they had been forced by the police or their physician to sign a written statement declaring their HIV-positive status, “a procedure used to create evidence that may form the basis for criminal charges against those suspected of putting others at risk.”

Many reported that they had experienced discrimination in the workplace. Approximately 11% had been refused a job because their were HIV-positive, 7% said they had been dismissed from employment because of their status, and 6% stated that they had been forced by family members to leave their homes due to their infection.

Mental health distress was common. Clinical depression was present in 39% of individuals and 37% had anxiety levels comparable to those found in psychiatric inpatients.

“Levels of depression, anxiety, and poor social support in this sample…were high and prevalent. Reports of discrimination were also common and show that AIDS-related stigma remains high in Russia,” comment the authors.

Unprotected sex with a partner of the opposite sex who was HIV-negative or of an unknown status was reported by 58% of individuals. Higher rates of sexual risk behaviour (71%) were present in men who have sex with men. Overall, approximately one-third of all acts of anal or vaginal sex were unprotected.

Greater experience of perceived HIV-related discrimination was associated with poorer condom use (p = 0.012).

A history of injecting drug use was reported by 346 individuals, and  52% of these individuals said they had injected in the past three months. Needle sharing was reported by 47% of these patients.

Sharing needles was associated with not having a primary partner, lower levels of education, and experiencing discrimination (all p < 0.05).

“These findings demonstrate the need to implement programs designed to encourage…risk reduction for infected persons seen in HIV clinical, social support, or other care service programs,” write the investigators.

Antiretroviral therapy had been offered to 54% of the patients. Two-thirds of these individuals were taking treatment, 18% were waiting to start, and 16% had declined. The median duration of therapy was a little under 20 months.

Not being offered HIV therapy was associated with shorter duration of HIV infection (p < 0.01), and depression (p < 0.01). Poor mental health was also associated with a refusal to start taking antiretroviral therapy (p < 0.01).

Reported adherence was high as 90% of patients had an adherence level of at least 90%.

“However, we relied on self-reports of adherence for only a 2-day period, and self-report data can reflect an underreporting of socially undesirable responses,” caution the investigators.

Heroin use in the past three months was associated with poorer adherence (p < 0.01).

Concerned by their findings, the authors conclude: “It is imperative that PLH in Russia should receive improved and tailored services to reduce HIV transmission risk behaviors and improve life quality.”

 

Taaken from Aidsmap, 23 May, 2011

Posted: May 23, 2011 by Nozizwe

New regimen prevents TB in 12 weekly doses

A large trial has shown that a 12-week course of combination treatment for latent tuberculosis is just as effective as a 9-month course of isoniazid in countries with a low to moderate burden of TB, with the additional advantage that the new regimen can be dosed once a week.

The findings, from the Prevent TB study, were presented this week at the American Thoracic Society’s International Conference in Denver.

However, the applicability of the findings for people with HIV and for settings with a high burden of TB is unclear, and more research will be needed.

Latent tuberculosis (TB) is an infection with TB that has been contained by the immune system, does not cause symptoms and cannot be passed on to other people. Latent TB may develop into active TB if the immune system weakens due to malnutrition or HIV infection, for example.

Preventive treatment with a six to nine-month course of the antibiotic isoniazid reduces the risk of developing active TB by between 30 and 60%, but the six to nine month course of daily isoniazid may be difficult for patients to take.

As a result there has been interest in determining whether it is possible to shorten the course of TB preventive treatment.

The Prevent TB trial was designed more than ten years ago, to compare:

• 12 weeks of treatment with a once-weekly regimen that combined isoniazid (900mg tablet) with a new anti-TB drug rifapentine (900mg in six 150mg tablets), given as directly-observed treatment.
• Standard TB preventive TB treatment with nine months of self-administered isoniazid (300mg once daily), the recommended preventive regimen in the United States.

The trial recruited 8,053 participants in the United States, Canada, Brazil and Spain, but excluded participants with HIV infection who were taking antiretroviral drugs, due to drug interactions between rifapentine and HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors.

Participants were randomised to the experimental regimen or to standard treatment, and followed for 33 months after enrolment to assess the effect on development of active TB and survival, as well as adherence and side-effects.

The new regimen was associated with fewer cases of active TB (7 versus 15 in the standard treatment arm) and better adherence (82% vs 69% completed the course of treatment).

“Although the standard regimen is very effective in treating latent TB infection, ensuring that those who need treatment both begin and complete the lengthy, cumbersome isoniazid regimen is challenging,” said CDC Director Thomas R. Frieden, M.D.  “New, simpler ways to prevent TB disease are urgently needed, and this breakthrough represents one of the biggest developments in TB treatment in decades.”

In the light of these results, new US guidelines on TB preventive treatment are expected before the end of the year.

Further research will be needed in countries with a high burden of TB, and in people with HIV.

 

Taken from Aidsmap, 23 May 2011

Posted: May 23, 2011 by Nozizwe

Further cuts in drug prices make tenofovir more affordable for low-income countr

UNITAID, the international drug purchase fund, and the Clinton Health Access Initiative have announced further price reductions for key antiretroviral drug regimens, including a 14% reduction in the price of tenofovir-based triple combination therapy, to $159 a year.

The reduced prices will be available to over 70 low- and middle-income countries that form part of the CHAI Procurement Consortium, and have been negotiated with a range of generic drug manufacturers.

In part, prices have been pushed lower because of collaboration between pharmaceutical chemists employed by CHAI and generic drug manufacturers, designed to identify ways in which some drugs can be made more cheaply. This work was funded by the United Kingdom government’s Department for International Development.

Reductions in the cost of raw materials has also helped; identifying a new supplier for a key ingredient of tenofovir knocked $15 off the annual cost of tenofovir.

However, it is the prospect of larger guaranteed orders that has galvanised most manufacturers to offer lower prices for new drugs.

World Health Organization guidelines, updated in late 2009, now recommend that wherever possible, people with HIV should start treatment with a tenofovir-based three-drug combination. If that is too expensive, national treatment programmes should use AZT-based combinations, which are less toxic than the d4T-based combinations widely used in the early years of treatment scale-up.

The main price reductions include:

• A reduction in the price of tenofovir-based first-line treatment to $159 a year, down from $400 in 2008, and down 14% in the last year;
• A reduction in the price of a protease inhibitor-based second-line treatment regimen, to $410 a year.

CHAI said that it expects the cost of tenofovir-based treatment to fall below the cost of twice-daily AZT-based treatment within the next few years as demand grows. It projects that demand for tenofovir-based treatment will grow from one million patients in 2010 (18% of the first-line market) to 4.2 million in 2013 (53% of the first-line market).

The World Health Organization recommends that second-line antiretroviral treatment should be protease inhibitor-based, using either atazanavir or lopinavir boosted with ritonavir.

The partners also announced that a co-packaged combination of atazanavir, heat-stable ritonavir, tenofovir and 3TC will soon be available as second-line treatment, subject to approval by the US Food and Drug Administration and the World Health Organization, at a price of $395 a year.

In comparison lopinavir, coformulated with ritonavir, will be available at a generic price of $399 a year without tenofovir and 3TC.

CHAI said it anticipated a rapid switch to atazanavir when the new price becomes available, and further significant reductions in cost as demand grows. (See full price list here).

Switches in drug regimens that drive costs lower will also have the effect of freeing up money to treat new patients. The partners estimate that price reductions could enable an extra 500,00 people to be treated, although this figure assumes that countries would have switched to new drugs without the incentive of price reductions.

However, even without any new enrolment of patients on treatment, the UK Department for International Development estimates that the effort to drive down prices by UNITAID and CHAI will result in savings of $600 million over the next three years when compared with 2008 prices. If treatment scale-up continues at the same pace as over the past three years, the scale of savings could reach $1 billion by 2014.

 

Taken from Aidsmap, 23 May 2011

Posted: May 23, 2011 by Nozizwe (updated June 22, 2011)

Progress on HIV treatment 'fragile', says MSF report

Although major strides have been made in achieving access to antiretroviral treatment in low and middle-income countries, progress is fragile and highly vulnerable to diminishing attention from donors, Medecins sans Frontieres says in a new report published ahead of next month’s United Nations General Assembly Special Session on AIDS .

The report also highlights progress towards implementation of 2009 World Health Organization guidelines in 16 countries that represent half the global burden of HIV infection.

The guidelines include recommendations that countries shift towards providing earlier treatment, and adopt less toxic first-line drug regimens.

The survey found that 12 of 16 countries have either shifted to recommending earlier treatment, or are likely to do so shortly.

First-line treatment with d4T (stavudine) was the norm when countries began to scale up antiretroviral treatment in the early 2000s because the drug was cheap and easy to coformulate in fixed-dose combinations. Over time it has become clear that a high proportion of patients suffer unacceptable levels of toxicity as a result of taking this drug, and WHO has recommended using tenofovir or AZT instead.

However, changes in first-line treatment that would result in the use of tenofovir, a less toxic drug, have been implemented in only half of the countries. In the remainder national guidelines now recommend AZT, which although less toxic than d4T, still causes some long-term side effects. AZT is cheaper than tenofovir.

The survey also found that almost all countries have opted to implement the cheaper of two optional regimens for prevention of mother to child HIV transmission. The World Health Organization has recommended that at a minimum, either pregnant women should receive three-drug antiretroviral therapy until the end of the breastfeeding period, or they should receive short-course prophylaxis with two drugs. Only two countries have chosen to adopt the triple-drug protocol.

While some countries have already achieved fairly good treatment coverage for those who need it, seven of the 16 countries in which MSF works are still unable to provide treatment to more than 40% of people with CD4 counts below 350. While Zambia is already able to provide treatment to 68% of people who need it, and Kenya and Ethiopia to around half, only 32% of eligible patients are receiving treatment in Mozambique, and 37% in South Africa.

Medecins sans Frontieres says that this year's UN meeting on AIDS is very important as it will possibly be the last meeting of its kind for years to come and may therefore shape the response to the HIV epidemic for the next five to ten years. 

"Today, ten million people are in urgent need of treatment," says Dr Tido von Schoen-Angerer, Executive Director of MSF's Access Campaign.  "We know so much more from the past decade about how to get treatment to as many people as possible as quickly as possible.  With the right policies in place, we could triple the number of people on treatment without tripling the costs. But if governments don't support a treatment target, they are sending a clear message that they do not intend to ever come to grips with this pandemic."

      Taken from Aidsmap, 23 May 2011

Posted: May 23, 2011 by Nozizwe

Rilpivirine (Edurant) approved in United States

A new non-nucleoside reverse transcriptase inhibitor, rilpivirine, has been approved for first-line antiretroviral treatment by the United States Food and Drug Administration.

Rilpvirine (brand name Edurant) is licensed for use in combination with other antiretroviral drugs, and manufacturer Johnson & Johnson / Tibotec is partnering with Gilead to develop a three-drug combination pill that will allow rilpivirine to be taken in one tablet with tenofovir and FTC.

Rilpivirine, previously known as TMC-278, was licensed on the basis of clinical trials that compared the drug with efavirenz, the most commonly prescribed first-line NNRTI. In one study the drugs were tested in combination with tenofovir and FTC; in the other, the drugs were tested in combination with one of three nucleoside analogue combinations (tenofovir/FTC, AZT/3TC or abacavir/3TC).

In a press release announcing the approval of rilpivirine the US Food and Drug Administration noted that the clinical trials that led to the licensing of rilpivirine had demonstrated a similar rate of viral load suppression after 48 weeks of treatment.

However patients with viral load above 100,000 copies/ml at the beginning of treatment were less likely to achieve undetectable viral load than those with lower viral load when treated with rilpivirine. As a consequence a higher rate of viral failure was observed in patients who received rilpivirine (13% vs 9%).

Patients who experienced viral failure were also much more likely to develop drug resistance, both to NNRTIs and to 3TC or FTC.

In patients receiving efavirenz there was no difference in viral load response according to the level of viral load at the beginning of treatment.

These studies also showed that patients taking rilpivirine were less likely to stop treatment due to central nervous system side-effects such as insomnia, depression, dizziness, or due to rash, when compared to patients taking efavirenz.

Rilpivirine is taken once daily with food.

European marketing authorisation is likely to be granted in the second half of 2011.

 

Taken from Aidsmap, 22 May, 2011

Posted: May 23, 2011 by Nozizwe

HIV and TB

Tuberculosis (TB) is the single most important cause of serious illness and death in people with HIV across the world.

New research has shown that a 12-week course of combination antibiotic treatment is an effective therapy for latent TB (TB that isn’t currently causing illness). However, latent TB may develop into active TB if the immune system weakens, due to malnutrition or HIV infection, for example.

Preventive treatment with an anti-TB drug called isoniazid can reduce the risk of latent TB turning into active disease. This treatment is normally taken for six to nine months.

But researchers wanted to see if the duration of treatment could be shortened to just 12 weeks if isoniazid was combined with a newer anti-TB drug called rifapentine.

They therefore compared the effectiveness of this treatment to standard, single-drug isoniazid therapy.

Results showed that 12 weeks of treatment with the new combination was just as effective as longer-term isoniazid therapy.

“New, simpler ways to prevent TB disease are urgently needed, and this breakthrough represents one of the biggest developments in TB treatment in decades,” said one expert.

Further research is needed to see if the combination is effective in patients with HIV.

NAM’s patient information booklet HIV & TB is available on our website in English, French, German, Italian, Portuguese and Spanish.

  HIV Treatment Update

The May edition of our regular publication HIV treatment update is back from the printers and being sent out.

To find out more about what's covered in this edition visit our website, or contact us on 020 7840 0050 or info@nam.org.uk to subscribe.

Subscription is free to anyone personally affected by HIV.

Read more about HIV treatment update – May 2011 >>

HIV drug prescribing in London

Changes have been announced by the NHS in London about the prescribing of antiretroviral therapy.

The new agreement was developed to reduce the amount of money spent by the NHS on anti-HIV drugs and it applies from April 2011.

Read more about the changes on our new webpage.

As well as information and links we have produced two factsheets for patients, which we are happy for you to download and distribute.

We'd welcome any feedback on the factsheets and the information on this webpage, as we will be updating it regularly.

New title from NAM

We've launched a brand-new title: HIV & UK African Communities as part of our African communities engagement project.

The book includes chapters on key issues faced by African people living with HIV in the UK, a comprehensive mapping of HIV and related support services and personal stories about different aspects of life with HIV.

As well as being available in print, HIV & UK African Communities is also available as a resource on our website.

Read the content online or order a print edition >>

British 10K London Run

Fancy running in the British 10K London Run and raising money for NAM?

We have five places up for grabs for the run on July 10th.

If you would like to apply for one of them, visit our website to tell us about yourself. The deadline for filling in the online form is May 27th.

Find out more here >>

Police investigations

UK HIV charity NAT has published a guide for people living with HIV in England, Wales and Ireland entitled Police Investigation of HIV Transmission.

You can download a PDF of the guide from the NAT website here.

The guide explains a new piece of guidance for police forces, approved by the Association of Chief Police Officers (ACPO), which sets out good practice for police investigating cases relating to criminal transmission of HIV.

You can read more about the ACPO guidance on the NAT website here.

For more information on the background to HIV and the criminal law, including laws and practice around the world visit www.aidsmap.com/law.

 

Taken from HIV Weekly, 18 May 2011

Posted: May 19, 2011 by Nozizwe (updated June 22, 2011)

HIV care – moving clinic

 

Canadian research has shown the importance of connecting with HIV care if you need to find a new clinic because you move.

The researchers think that some patients drop out of HIV care when they move, and experience HIV disease progression as a result.

Their study involved people who received continuous care from their clinic; people who moved away but then came back to the clinic; and people who dropped out of care – were ‘lost to follow-up’ – but subsequently came back to the clinic.

Average CD4 cell counts increased for patients who remained in continuous care.

However, the CD4 counts of patients who moved away were much lower when they returned to the clinic. This was also the case for returning patients who had been lost to follow-up.

In addition, returning patients were more likely to develop an AIDS-defining illness.

The researchers found that only a third of patients who moved had their notes requested by a new clinic.

This led investigators to conclude that many patients effectively dropped out of HIV care.

“Efforts to transfer care seamlessly to other HIV care centres needs to be reinforced to avoid negative health consequences,” stress the researchers.

You can read a feature article ‘Lost to care - the mystery of the disappearing patients’ on our website. To find HIV clinics and services local to you, visit our online e-atlas.

 

Taken from HIV Weekly 18 May 2011

Posted: May 19, 2011 by Nozizwe

HIV treatment and infectiousness

A major study has been stopped early after it showed that HIV treatment reduced the risk of HIV transmission to an uninfected sexual partner by 96%.

The international study – called HPTN 052 – involved 1736 male-female couples where one partner was HIV-positive and the other HIV-negative.

Participants were randomised into two groups.

The HIV-positive people in the first group started HIV treatment immediately, and in the other group they waited until their CD4 cell count fell to 250.

The study started enrolment in 2005 and was meant to continue until 2015.

However, the study was stopped early because its findings showed that HIV treatment dramatically reduced the risk of transmission to the HIV-negative partner.

There were 28 new HIV infections that were genetically linked to the HIV-positive partner – 27 of these were in couples where the HIV-positive partner wasn’t taking HIV treatment.

This result suggests that HIV treatment was reducing the risk of transmission by 96%.

UNAIDS described the results as “a serious game changer”.

The use of HIV treatment as prevention has been a hot topic for a number of years.

Debate was kick-started by the ‘Swiss statement’.

Senior HIV doctors from Switzerland said, in 2008, that in certain circumstances, someone taking stable HIV treatment, should not be considered infectious to their sexual partner.

For this to be the case, they said a person needed to:

• Be taking antiretroviral treatment and have had an undetectable viral load for at least six months.
• Take their treatment properly.
• Not have any other sexually transmitted infections.

The research their advice was based on was in heterosexual couples and the authors have since said that the statement covered only heterosexual transmission.

Not all doctors agreed with the statement, but there is a growing consensus that effective treatment does dramatically cut the risk of HIV transmission.

But prevention advice still stresses the importance of condom use. If you and an HIV-negative partner are having unprotected sex, or are thinking about it, it’s important to talk to each other about the possible risks and implications, so that you can reach an informed decision that you’re both comfortable with.

Condoms, including female condoms, are a very effective method of preventing transmission of HIV, other sexually transmitted infections and unplanned pregnancy.

If you find using condoms difficult, find it difficult to use them all the time, or are thinking of stopping using condoms to start a family, it’s a good idea to talk to your HIV doctor, or another member of your healthcare team.

Visit our online ‘Treatment as Prevention’ resource for more discussion and information on previous research.

 

Taken from HIV Weekly, 18 May 2011

Posted: May 19, 2011 by Nozizwe (updated June 22, 2011)

HIV study claims one in eight children resistant to drugs

One in eight children born with HIV becomes resistant to the three main classes of drugs used to suppress the virus within five years of starting treatment.

The first major study of drug resistance in young people, which looked at 1,000 European children born with HIV, raises questions about the suitability of anti-retroviral drugs for the young.

Drugs fail because the virus becomes resistant to them. This can happen if people take them erratically or stop taking them. Resistance sets in with adults, but more slowly.

But part of the problem, say Nathan Ford and Alexandra Calmy, is that the drugs available are not tested on children or turned into formulations that are easy for children to take. The doctors work for Médecins sans Frontières, which treats some of the 2 million children living with HIV, who were infected during childbirth – most of them in the developing world. Half of the children born with HIV die before their second birthday, they point out.

Even in the US and Europe, drugs for children with HIV are limited. "Of the 22 antiretroviral drugs currently approved by the US food and drug administration, five are not approved for use in children and six are not available in paediatric formulations," they write in a commentary published with the study in the Lancet medical journal.

"Additionally, treatment has to be constantly adjusted for bodyweight, and most paediatric antiretrovirals are formulated as syrups (often in large volumes) which are difficult to administer and store." Some of the drugs, they add, "are extremely unpalatable".

Half of the children born with HIV already die before their second birthday, they point out. To give more children a chance of staying alive, fixed-dose combinations of a three-drug cocktail are needed, in tablet form. They call on "drug developers, clinical trial investigators and drug regulators" to prioritise the production of better HIV drugs for children.

The study was carried out mostly in the UK, Ireland, Spain, the Netherlands and France, with smaller numbers also from Denmark, Italy and Belgium. The children were all younger than 16 and had started treatment with three or more drugs between 1998 and 2008.

The failure rate in the three main classes of drugs – known as nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs), non-NRTIs (NNRTIs), and protease inhibitors – was 12% within five years of starting. There were problems even with young children, where the parent or carer would be responsible for giving the medicine, but the failure rate was higher in older children.

"Drug adherence is a challenge for children and young people with any chronic disease. For those with HIV infection, there are additional factors, including coming to terms with disclosure of their HIV status, secrecy and guilt among adult family members and dealing with HIV alongside their own sexual development. Fear of stigma increases their isolation and tendency towards denial, all of which might adversely affect drug adherence."

 

Taken from Aidsportal, 12 May 2011

Posted: May 12, 2011 by Nozizwe

A TRIBUTE TO DAVID CAIRNS MP BY THE AHPN

 

PRESS RELEASE

10

A TRIBUTE TO DAVID CAIRNS MP BY THE AHPN

th May 2011

The African Health Policy Network (AHPN) is very saddened to hear of the death of the chair of the All Party Parliamentary Group on HIV and AIDS (APPGA), David Cairns MP. It is reported that he had been ill with acute pancreatitis for some weeks and died in hospital last night.

 

AHPN recalls that David used his first speech in parliament after his appointment to speak out against "the wind of oppression" against sexual minorities in Africa and the "utterly disastrous effect" it is having on HIV and AIDS. The full speech can be found here.

David’s work in parliament as chair is highly appreciated by African community groups and people living with or affected by HIV in the UK. His work included mobilising supporters willing to speak in debates, tabling questions from community groups via the local constituencies and meeting Ministers. The vice chairs of the APPGA will continue the work on raising the profile of HIV in parliament and the AHPN encourages all members keep up the enthusiasm for engaging with this vital work that influences policy, though David will be sadly missed.

Eunice Sinyemu, Head of Policy and Deputy CEO of the AHPN says, "David will be greatly missed by many people particularly in the HIV sector where he contributed greatly during his time as a chair of the APPGA. AHPN is eternally grateful for his support for our Destination Unknown campaign. Our sincere condolences go to his family and friends."

Maureen Ndawana, Community Network Assistant from Ffena says, "This sad news comes at a time when individuals living with HIV recognise the importance of informing their local MPs about the unmet HIV needs within the African community in the UK. Ffena members will continue contributing to national debates in respect of the significant work David started."

Notes for Editors:

•

 

The African Health Policy Network (AHPN) is an umbrella organisation of mostly African-led community based organisations that enables Africans to speak with a collective and representative voice on matters of HIV and sexual health, with a mission to advance the health and well being of Africans living in the UK. For further information about the AHPN see www.ahpn.org. All Party Parliamentary Group on HIV and AIDS is a backbench cross-Party Group of MPs and Peers in the UK Parliament at Westminster. Learn more here. Ffena is a network of Africans in the UK living with and affected by HIV and sexual health needs that enables their experiences to be shared and their voices to be heard. Ffena is a Luganda word meaning '[we] all together'. Learn more about Ffena here.

 

•

 

•

Press contact: Dorothy Nyapendi – Communications Officer

African Health Policy Network

Email – Dorothy.nyapendi@ahpn.org Telephone: 0207 017 8911

Posted: May 11, 2011 by Nozizwe (updated June 22, 2011)

NICE supports expansion of HIV testing at GP's and in hospital settings

In its first ever guidance related to HIV, the health watchdog NICE recommends today that health services not concerned with sexual health take a greater role in offering HIV tests to black African people and to men who have sex with men.

NICE also encourages outreach testing projects for gay men in venues such as saunas and cruising grounds, using rapid point-of-care tests.

The National Institute for Health and Clinical Excellence (NICE) issues recommendations to the NHS about the most effective and cost-effective treatments and public health interventions to provide. In some cases, NHS bodies are legally required to fund medicines and treatments which are recommended by NICE.

Guidelines on HIV testing have been previously issued by organisations representing specialist clinicians such as the British HIV Association (BHIVA) and the British Association for Sexual Health and HIV (BASHH). Their most recent guidelines recommended that HIV testing should be offered to patients in a wide range of healthcare settings, including GP surgeries and most hospital departments.

Implementation of that part of the guidelines has generally been limited, although pilot projects have established that widespread HIV testing is feasible, acceptable to patients and effective in identifying a substantial number of people with undiagnosed HIV.

But with NICE today endorsing large parts of the BHIVA / BASHH guidelines, there may be more hope that non-specialist clinicians will take further steps to promote HIV testing.

NICE have produced public health guidance on increasing the uptake of HIV testing in two related documents. One concerns interventions for men who have sex with men, the other work with black African communities.

The document concerning black African communities repeats a number of the key recommendations in the BHIVA / BASHH guidelines. In all healthcare settings (including general practice, outpatient and emergency departments), an HIV test should be routinely offered and recommended to all patients who come from high prevalence countries, patients who have had sexual contact abroad and patients who have symptoms that may be related to HIV.

In addition, everybody attending a sexual health, antenatal, termination of pregnancy, drug dependency, tuberculosis, hepatitis B, hepatitis C or lymphoma services should be offered an HIV test.

At health services in areas of relatively high HIV prevalence, healthcare workers ‘should consider’ recommending HIV testing when registering and admitting new patients. In addition, an HIV test should be offered and recommended to all patients who are having another blood test anyway.

Areas of high HIV prevalence are those in which more than two in 1000 have diagnosed HIV. This is the case in most parts of London as well as in places such as Brighton & Hove, Manchester, Blackpool, Salford, Bournemouth and Eastbourne that have historically had high HIV prevalence. Areas which have experienced more recent increases in HIV prevalence such as Luton, Watford, Harlow, Southend-on-Sea, Reading, Slough and Crawley are also included, with around a fifth of the English population living in areas touched by these recommendations.

The wording of the document on testing men who have sex with men is somewhat different, but the implications are similar. In all healthcare settings, male patients who are known to be gay or bisexual should be offered and recommended an HIV test. General practitioners should repeat the offer on an annual basis.

At health services in areas of high HIV prevalence, all male patients (whether they are known to have sex with men or not) should be offered and recommended a test.

For both population groups, NICE recommends that directors of public health and commissioners develop a local strategy for increasing testing rates. The strategy should lead to more health professionals offering HIV testing and more individuals accepting the offer. The strategy should be developed in consultation with local voluntary organisations and community members and should pay particular attention to groups who are less likely to access services.

Community engagement and involvement is seen as particularly important in relation to black African communities. NICE recommends that community members should be recruited and trained to act as champions and role models. Programmes need to address misconceptions about HIV testing and treatment, promote the benefits of early diagnosis and tackle HIV-related stigma.

Health promotion interventions promoting testing to men who have sex with men should be encountered in venues, such as saunas or websites, which facilitate sex between men.

Moreover, the guidance supports outreach testing programmes in high-prevalence areas and also in venues where high-risk sexual behaviour between men occurs. This could include saunas and cruising areas. NICE appears to be more enthusiastic than BHIVA / BASHH about such projects, although they do note that testing will not be appropriate in all such venues. In such settings, rapid tests (using mouth swabs or fingerprick blood samples) should be provided by trained staff, in a secluded or private area.

All testing services (including community testing) need to have clear referral pathways to confirmatory HIV testing, HIV treatment services and support groups. Moreover people who test negative may need referral to counselling and safer sex interventions, as well as repeat testing (for example, if a risk has been taken during a test’s window period). Men who have sex with men are recommended to test annually, or more frequently if their sexual behaviour suggests that they may be at higher risk.

Dr Clare Gerada, chair of the Royal College of General Practitioners commented: “It is important that all health professionals do everything possible to encourage HIV testing amongst high risk groups. The RCGP welcomes the new NICE guidelines and we are sure that GPs will help patients come forward for testing."

Deborah Jack, Chief Executive of NAT (National AIDS Trust) said: "It is crucial that HIV testing becomes ‘normalised’ in our society, not just among gay men and African communities, but also amongst health professionals. Many people with HIV attend NHS services for years without being offered an HIV test and this neglect needs to be addressed and stopped." She called for late HIV diagnosis to be used a key outcome indicator in public health monitoring and for the new government body, Public Health England, to ensure that NICE's recommendations are "consistently implemented across the whole of the NHS and public health system".

 

Taken from Aidsmap, 23 March 2011

Posted: May 10, 2011 by Nozizwe

HIV drug prescribing in London

Changes have been announced by the NHS in London about the prescribing of antiretroviral therapy. The new agreement was developed to reduce the amount of money spent by the NHS on anti-HIV drugs and it applies from April 2011.

 

• Summary
• London prescribing - NAM factsheets
• aidsmap news
• aidsmap treatment information
• External links
• Questions, concerns or looking for more information?

Summary

People in London who are starting HIV treatment for the first time will now normally be prescribed a combination of drugs based on Kivexa (abacavir/3TC) unless there is a clinical reason not to prescribe it.

People will be offered efavirenz (Sustiva) as the first option alongside Kivexa, with nevirapine (Viramune) or atazanavir (Reyataz) as alternative options.

Reasons not to prescribe Kivexa include having a viral load over 100,000 copies/ml, a positive genetic test for hypersensitivity to abacavir, having HIV that is resistant to one of the drugs, or being at high risk of a heart attack in the next ten years.

Therapy based on Truvada (tenofovir/FTC) will generally be prescribed in these situations. Truvada will also be given to people with hepatitis B, and those being treated for hepatitis C.

People who start therapy with a protease inhibitor will now normally be given atazanavir (Reyataz) boosted by ritonavir (Norvir). Patients who are already taking a protease inhibitor may be assessed to see if they can change to atazanavir. People who cannot tolerate atazanavir or have resistance to it will be prescribed darunavir (Prezista) as the alternative protease inhibitor.

The integrase inhibitor raltegravir (Isentress) will only be used in very specific circumstances: short-term use in first-line treatment for patients with very complex drug interactions, or for pregnant women diagnosed with HIV late in pregnancy, where there is a need for very rapid viral load reduction.

It has been emphasised that no patient will be given sub-optimal treatment or therapy that involves a risk of serious side-effects.

The change in prescribing practice for first-line treatment will not initially affect patients on current regimens but will be applied to new patients and to patients who need to change to a second-line protease inhibitor-based regimen.

The decision was made by the London HIV Consortium Drugs & Treatments sub-group after primary care trusts in London told HIV prescribers that their budget would not grow this year. This meant that hospitals needed to save £9 million on drugs in order to accommodate other HIV patient and clinic costs. HIV patient numbers rose by 5.3% in London in 2009 alone.

London prescribing - NAM factsheets

• Starting HIV treatment? Information for patients in London (Factsheet)
• Already taking HIV treatment? Information for patients in London (Factsheet)

aidsmap news

• Some London clinics may have difficulty meeting drug prescription targets

  Some HIV clinics in London may have difficulty conforming to the new targets set for the proportion of patients who are prescribed cost-saving regimens, according to...

  Published on 20 April 2011 | By Gus Cairns

• HIV drug prescribing in London to change from this month

  London HIV patients will start treatment with Kivexa (abacavir and 3TC) rather than tenofovir and FTC for at least the next two years in a bid...

  Published on 06 April 2011 | By Gus Cairns

aidsmap treatment information

• Atazanavir (Reyataz)
• Darunavir (Prezista)
• Kivexa (abacavir/3TC)
• Raltegravir (Isentress)
• Truvada (tenofovir/FTC)
• View full A to Z of antiretroviral drugs

External links

• Current treatment guidelines on the British HIV Association (BHIVA) website (PDF)
• Summary of messages from the London HIV Consortium (PDF)
• Information on the changes from treatment activist group HIV i-Base
• Statement from the London Specialised Commissioning Group
• Information on the changes from THT's myhiv website

Questions, concerns or looking for more information?

If you're concerned about these changes, or how they might affect your treatment and care, it's a good idea to talk to your doctor, or someone else in your healthcare team.

If you would like to talk it over with someone who doesn't work at your clinic, you could contact your local HIV support organisation, or an HIV helpline.

• The Terrence Higgins Trust helpline, THT Direct, is available Monday to Friday 10am to 10pm, Saturday and Sunday noon to 6pm, on 0845 12 21 200.
• The HIV i-Base helpline is available Monday to Wednesday noon to 4pm, on 0808 8006 013.

If you are concerned that you are being asked to change treatment inappropriately, then contact one of these helplines for advice.

We will add more information to this page as it becomes available. The London HIV Consortium will meet again on 25 May and there may be some new information after that meeting.

If you think there are other aspects of the changes to prescribing that we should cover, or other information you would find useful, please contact us by emailing info@nam.org.uk or filling in the online contact us form.

 

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Taken from Aidsmap, 9 May 2011

Posted: May 10, 2011 by Nozizwe (updated June 22, 2011)

One in eight European children with HIV experienced failure of three drug classe

One in eight children and adolescents receiving HIV treatment at major HIV clinics in Europe experienced failure of three classes of antiretroviral drugs after five years of treatment, highlighting the need for formulations of new antiretroviral drugs to be developed that are suitable for children, European researchers report in The Lancet.

Triple-class failure implies that a child has experienced the failure of at least two antiretroviral regimens, one containing a non-nucleoside reverse transcriptase inhibitor combined with a nucleoside analogue, and one containing a protease inhibitor combined with a nucleoside analogue. It also implies a degree of cross-resistance to other drugs in the same class.

Children were twice as likely as adults with HIV in Europe to experience failure of their first antiretroviral regimen.

The PLATO II investigators for the Collaboration of Observational HIV Epidemiological Research in Europe (COHERE) reported a retrospective cohort study of 1007 children, among whom over one-third (33%) had started a third drug class after a median of 4.2 years (of which 105 (44% or 10% overall) were on a failing regimen).

About 25% of those who developed triple-class virological failure had never achieved viral suppression (a viral load measurement under 500 copies/ml).

The longer the children were on ART the greater the risk of triple-class virological failure: after five years the risk was 12% (95% CI: 9.4-14.6).

Approximately 2 million children are living with HIV, the majority infected through perinatal transmission. An estimated 700 children die every day because of AIDS-related causes. Without treatment an estimated 50% will die before they reach the age of two.

Antiretroviral therapy has dramatically improved the prognosis for HIV-infected children. Children have responded well to protease inhibitors (PIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs). Guidelines now recommend starting treatment as soon as possible after HIV diagnosis.

Results from adults treated, in both resource-poor and resource-rich settings, with all three classes of antiretrovirals (PIs, NNRTIs and nucleoside reverse transcriptase inhibitors (NRTIs) suggest that long-term viral suppression is possible and virological failure happens slowly. It is unclear whether the same is true for children who will need to maintain viral suppression the longest.

The major challenge in treating children is to minimise virological failure and the development of drug resistance so that children will continue to have treatment options throughout adolescence and adulthood.

Alexandra Calmy and Nathan Ford from Médecins Sans Frontières in an accompanying Comment stress the potential difficulties for children, notably in resource-poor settings where 90% of HIV-infected children live: limited availability of current and effective treatment regimens, unclear strategies for the best drug sequencing as well as difficulties in maintaining good adherence from infancy to adulthood, all of which may contribute to drug resistance and virological failure.

The authors looked at the rate and predictors of triple-class virological failure to the three original drug classes in children.

From 1998 to 2008, in COHERE, the rate of triple-class failure was analysed in children under 16 years of age infected perinatally who started antiretroviral therapy with three or more drugs. 1007 children from 14 COHERE cohorts were identified with over 90% from the UK and Ireland, Spain, Holland and France.

Incidence of triple-class virological failure increased over time, reaching close to 20% after eight years. The authors note that the rate of triple-class failure was steepest in the first two years after having started ART, after which it continued to rise, but more gradually.

Older age (10-15) when starting ART was associated with an increased risk of failure.

Calmy and Ford suggest these findings be understood in context. Close to a quarter of the children had started ART in 2000 when less effective regimens were in use and standardised treatment guidelines lacking.

However, Calmy and Ford note the findings give cause for concern.

The overall virological failure rate is comparatively low. Nonetheless when the analysis is limited to children exposed to boosted PIs the cumulative proportion of failure is twice that of adults in the same cohort collaboration, 8.2% (95% CI: 5.1-11.2) compared to 4.2% (95% CI:  3.8-4.6) HR 2.2 (95% CI: 1.6-3.0, p<0.0001).

This raises the critical issue of treatment durability. Calmy and Ford add that no matter what the age the goal is to achieve and maintain sustained virological suppression. The fact that a significant number of children experiencing virological failure had never achieved virological suppression is disturbing, they add.

Reasons include: the complexities around adherence, particularly in very young children who depend on caregivers; very limited and often poorly adapted treatment options.

In young children and adolescents the authors note overlapping social issues: stigma, secrecy and guilt, disclosure as well as sexual development all contribute to poor adherence. Few studies, they add, have looked at these issues.

While they welcome the World Health Organization’s (WHO) efforts to issue user-friendly dosing tablets, Calmy and Ford express concern “that paediatric antiretrovirals are not currently a part of WHO’s work on priority medicines for maternal and child health.”

Calmy and Ford stress the urgency of developing new fixed-drug formulations for children. The absence of clinical data on the use of specific drugs in children hinders the process.

Calling upon researchers and drug developers to “prioritise the pursuit of paediatric indications for antiretroviral drugs” they note, “…children [notably in resource-poor settings] receive a lower standard of care than do adults.”

They conclude “The fact that the Drugs for Neglected Diseases Initiative…has recently included paediatric HIV/AIDS in its portfolio is telling: paediatric HIV/AIDS is a neglected disease.”

 

Taken from Aidsmap, 9 May 2011

Posted: May 10, 2011 by Nozizwe

Heart failure more common in people with HIV

People with uncontrolled HIV infection are significantly more likely to suffer heart failure than people without HIV infection, according to results of a large cohort study of US military veterans published this week in Archives of Internal Medicine.

The study adds to the accumulating evidence that untreated HIV infection may increase the risk of heart disease.

Heart failure is a gradual weakening of the heart that leads to increasing breathlessness and weakness, and requires medication or surgery as the condition becomes more severe.

Previous studies have looked at myocardial infarction, stroke or other cardiovascular events. Heart failure is a cardiovascular outcome that may occur for a variety of reasons, including heart attack, high blood pressure, disease of the heart muscle (cardiomyopathy), alcohol or cocaine abuse, and represents a progressive condition that requires active management rather than a one-off event.

The study evaluated heart failure in a large cohort of male US military veterans, and excluded anyone with pre-existing cardiovascular disease or cancer.

A total of 8,846 participants were evaluated, of whom 28.2% were HIV-infected. All participants were part of the Veterans Aging Cohort Study Virtual Cohort.

Participants had a median age of 48 years, and around 39% were African-American.

With regard to risk factors for heart disease those with HIV were more likely to smoke (55% vs 45%, p<0.001), to have a history of cocaine use (21.9% vs 15.7%, p<0.01) or hepatitis C coinfection (30.5% vs 11.4%, p<0.001). HIV-negative participants were more likely to have diabetes (24.8% vs 16.7%, p<0.001) or hypertension (28.8% vs 18.7%, p<0.001).

Rates of alcohol dependence and elevated lipid levels were similar in the two groups, but HIV-positive people had a lower mean body mass.

People with HIV infection were almost twice as likely to experience heart failure (incidence 7.2 vs 4.82 per 1000 person-years of follow-up, hazard ratio 1.81, 95% confidence interval 1.39-2.36).

Among individuals without chronic heart disease or a history of alcohol abuse HIV was second only to hypertension as a risk factor for heart failure, and tended to show a stronger association with heart failure than traditional risk factors such as smoking, high body mass and older age.

Individuals who had a detectable viral load on recruitment to the cohort (HR 2.28 vs HIV-uninfected), or who subsequently experienced viral load rebound after joining the cohort (HR 2.39), had a significantly higher risk of heart failure than those who had an undetectable viral load throughout their follow-up time in the cohort  (HR 1.10) (p> 0.01 and >0.03 respectively).

The authors say that their analysis is limited in its ability to fully quantify any effects of antiretroviral treatment by lack of data on antiretroviral drug regimens and adherence.

The authors suggest that ongoing HIV replication is an important risk factor, but also note that secondary infections of the myocardium (heart muscle) by opportunistic pathogens present in people with HIV, such as cytomegalovirus, Toxoplasma gondii and Cryptococcus neoformans could be responsible for some portion of heart failures.

They say that traditional risk factors for heart failure should not be ignored in people with HIV infection. Age, obesity, hypertension, diabetes, alcohol abuse and African-American race all remained significant predictors of heart failure even after individuals with chronic heart disease were excluded from the analysis, suggesting the extent to which modification of lifestyle factors is advisable in advance of any development of symptomatic heart disease.

“Interventions to minimize the modifiable traditional risk factors, including glycemic and blood pressure control, weight reduction and abstinence from alcohol are prudent strategies that should be emphasized,” the authors conclude.

They say more work is needed to determine whether heart failure in persons with HIV is chiefly systolic or diastolic, and to look at the effects of interventions such as glycemic control and anti-hypertensive medication on the risk of heart failure.

 

Taken from Aidsmap 9 May, 2011

Posted: May 10, 2011 by Nozizwe

Symptoms of primary HIV infection often mistaken for malaria, representing misse

Almost two-thirds of a cohort of Kenyans newly infected with HIV had sought treatment for fever, and 40% of these received presumptive treatment for malaria, but only 12% were tested for HIV, highlighting important missed opportunities for diagnosis and prevention of onward transmission, Eduard J Sanders and colleagues report in a prospective cohort study published in the advance online edition of AIDS.

Half of those treated were tested for malaria parasites; all were negative. Only six percent were suspected of having acute HIV infection; in spite of 25% having had a symptomatic sexually transmitted disease in the three months before an HIV diagnosis.

Many people within the first few weeks of HIV-infection (also known as acute HIV-1 infection or AHI) will experience a sudden onset of illness including: fevers, joint pains, headache, tiredness and rash. Many will seek care.

Identification of people with AHI presents an important public health opportunity.

Newly infected people are highly infectious and may account for a large number of new infections. Early diagnosis presents an opportunity for improved treatment and care as well as potential behaviour change.

It is common in resource-rich settings to seek urgent healthcare for these symptoms. However, the authors note that little is known about health care seeking behaviours in sub-Saharan Africa around the time of AHI.

Given the interest in using point-of-care tests for early diagnosis of AHI, the authors chose to look at healthcare seeking in patients diagnosed with AHI in Kenya.

In July 2005 a prospective open cohort of men and women at risk for HIV began in two research clinics in Kilifi district in Kenya. Men and women aged 18-49 years of age who reported transactional sex work or men having sex with men (MSM) were enrolled voluntarily. Volunteers were given either three-monthly or monthly (when receptive anal intercourse was reported) appointments.

Records covering clinical, counselling, treatment and laboratory work of all previously HIV-negative at-risk individuals who had seroconverted between July 2005 and October 2010 and had agreed to be a part of the AHI cohort were reviewed.

The cohort comprised a total of 72 volunteers (60 men and 12 women); 60% of whom had either p24-positive or RNA-positive or HIV-I discordant rapid test before seroconversion.

Median age at seroconversion was 25 (IQR: 22-28) for men and 24 (IQR: 23-27) for women. Over half had secondary or higher education. 93% of men were bisexual or homosexual; 77% (55) of men and 17% (2) of women reported receptive anal intercourse.

Before diagnosis 75% (54) reported fever. 69% (50) sought urgent care for symptomatic illness; 84% of whom had symptoms within a month of the estimated date of HIV infection. 32% first sought care in a non-research facility.

Over a quarter sought urgent care more than once before HIV diagnosis.

Only one in four patients with fever was tested for malaria parasites, yet in spite of negative results was treated for malaria.

Malaria treatment was strongly associated with fever (aOR: 46, 95% CI: 3-725) and a non-research setting (aOR: 5, 95% CI: 3-64).

However the World Health Organization’s (WHO) revised malaria treatment guidelines state that treatment be given upon a confirmed diagnosis. Treatment based on clinical symptoms can be considered only when “parasitological diagnosis is not accessible.”

The authors stress the urgent need for continued education for front line health care workers as well as for researchers working in a research setting.

The identification of people with acute HIV infection at point-of-care services will facilitate treatment and care as well as HIV prevention interventions.

The authors propose that, together with improved clinician training, a risk score algorithm is developed to evaluate acute HIV infection in resource-poor settings where previously malaria was the most common cause of fever.

The authors note that among research staff there was low recognition of AHI in spite of patients presenting with known predictors of HIV infection: symptomatic sexually transmitted infections and discordant rapid HIV test results before seroconversion.

While HIV is only one of many causes of fever in sub-Saharan Africa, the authors note they couldn’t determine whether testing for HIV was done at non research facilities but suspect it was not.

Limitations include the selection of a high-risk group; bias in recall; and differences in follow-up may have influenced estimated differences in illnesses in men compared to women.

The authors conclude the majority of adults with AHI in malaria-endemic areas seek urgent health care and most are treated presumptively for malaria. Improved recognition of AHI presents a public health opportunity for early diagnosis, treatment and care as well as improving HIV prevention strategies.

 

Taken from Aidsmap 9 May, 2011

Posted: May 10, 2011 by Nozizwe

A third of deaths in patients with HIV are attributable to other serious illness

A substantial proportion of the mortality in HIV-positive patients is caused by serious illnesses that were present before diagnosis with HIV, Danish investigators report in the online edition of the Journal of Acquired Immune Deficiency Syndromes.

Overall, a third of all deaths were attributable to illnesses that were already present at the time of HIV diagnosis. The study also showed that mortality rates were significantly higher in patients with HIV than in the general Danish population.

The introduction of effective antiretroviral therapy in the late 1990s transformed the prognosis of many HIV-positive patients. Non-AIDS-related diseases are an increasingly important cause of illness and death in patients with HIV, and the burden of such diseases is expected to increase as the HIV-positive population ages.

However, the impact of illnesses acquired by patients before their diagnosis with HIV on prognosis is poorly understood.

Therefore Danish investigators undertook a population-based study involving adult patients who were diagnosed with HIV in the country between 1997 and 2005. These individuals had at least two years of follow-up and each was paired with up to 99 age and sex-matched HIV-negative controls.

Details of co-morbidities were obtained from national registries. The investigators then calculated a Charlson Co-morbidity Index score for each patient and their matched controls. The Charlson C-morbidity Index includes serious illnesses which are scored from 1 to 3 according to their potential impact on mortality.

Mortality rates were calculated for individuals according to their Charlson Co-morbidity Index score (0, 1, 2, 3 and above).

A total of 1638 patients were diagnosed with HIV during the period of the study, and 195 of these individuals during 9350 person years of follow-up. This provided a mortality rate of 2.09% compared to a rate of just 0.39% in the general Danish population.

Another serious illness was present in 22% of patients at the time of their HIV diagnosis. This included 13% of patients who were co-infected with hepatitis C.

Pre-existing co-morbid conditions significantly increased the risk of death for patients. HIV-positive individuals who had one or more Charlson Co-morbidity Index points had significantly higher mortality rates than HIV-infected patients with no points on the index (mortality rate = 1.84; 95% CI, 1.32-2.57).

The investigators then compared mortality rates between HIV-positive patients and HIV-negative controls according to their Charlson Co-morbidity Index score. In each strata, HIV-positive individuals had a significantly higher mortality rate.

• Score 0: HIV =  1.70 vs. 0.27 per 100 person years.

• Score 1: HIV = 4.37 vs. 1.36 per 100 person years.

• Score 2: HIV = 8.06 vs. 2.44 per 100 person years.

• Score 3 and above: HIV = 10.15 vs. 5.84 per 100 person years.

This excess mortality in patients with HIV was explained by an interaction between HIV and the co-morbid conditions. Compared to patients with no Charlson Co-morbidity Index points, 59% of excess deaths for patients with one point could be attributed to this interaction, 66% of increased mortality for patients with two points, and 34% of excess deaths for patients with three or more points.

Overall, the investigators calculated that 32% of deaths in patients with HIV were due to serious illnesses that were present before HIV was diagnosed. Moreover, 45% of total mortality in patients with HIV was due to non-HIV-related causes.

“We found that morbidity acquired before HIV diagnosis was an independent risk factor for death,” comment the investigators.

“Almost half the mortality in persons diagnosed with HIV in a health care setting with free access to HAART [highly active antiretroviral therapy] stemmed from factors unrelated to the HIV disease or associated factors such as toxicity of antiretroviral drugs. Moreover, comorbidity acquired before HIV diagnosis acted synergistically with HIV as a risk factor for death.”

They add, “the considerable burden conferred by diseases acquired prior to HIV diagnosis, found in more than one in five patients in this study, calls for a comprehensive approach to treatment and care. Involvement of a team of medical specialists is clearly needed.”

The investigators suggest that lifestyle and self-care issues could contribute to the high prevalence of pre-existing serious illnesses present in patients at the time of their HIV diagnosis. “Further studies aiming to identify biological as well as sociocultural risk factors for comorbidity are required to increase our understanding of the complex interaction between HIV and diseases acquired before HIV.”

 

Taken from Aidsmap 9 May, 2011

Posted: May 9, 2011 by Nozizwe

HIV drug could lead to new cervical cancer treatment

The HIV protease inhibitor lopinavir (a component of Kaletra) triggers cells infected with human papillomavirus to produce an antiviral protein, inducing death of the cancerous cells, researchers at the University of Manchester report in the journal Antiviral Therapy.

“We have now found that lopinavir selectively kills HPV-infected, non-cancerous cells, while leaving healthy cells relatively unaffected,” said Dr Ian Hampson, from Manchester’s School of Cancer and Enabling Sciences.

The finding could lead to a new form of treatment for cervical cancer, which is caused by certain high-risk types of human papillomavirus.

At present treatment options for precancerous lesions caused by human papillomavirus, and for cervical cancer, are limited to freezing with liquid nitrogen in early stages, to electrocauterisation, or to surgery and chemotherapy in cases of cervical cancer.

However, in low and middle-income settings surgical treatments for precancerous lesions and for cervical cancer are often more difficult to deliver due to limited screening programmes, a lack of surgically trained staff and lack of medicines. Due in part to these obstacles, cervical cancer is the most common malignancy in women in sub-Saharan Africa.

Treatments which can be delivered easily by nurses and by affected women, starting on the day when a precancerous lesion is identified, could be particularly important in reducing progression to cervical cancer and deaths from cervical cancer in the developing world.

Although HPV vaccination is being introduced in some countries it cannot protect women who have already developed precancerous changes or who have been infected by high-risk HPV types that are not included in the two vaccines now available.

More generally, a drug which is effective against HPV could revolutionise the prevention of anal and oral cancers caused by HPV.

The University of Manchester researchers tested the effect of lopinavir on HPV-infected cells derived from cervical cancer and from human foreskin.

They found that lopinavir increased the production of ribonuclease L in cells infected with cancer-causing HPV types. HPV appears to reduce the expression of ribonuclease L, but the process which HPV reduces Ribonuclease L expression is inhibited by lopinavir.

The authors also speculate that the same process could lower host antiviral defences and so permit infection with other viruses, indicating a possible explanation for the association between HPV infection and subsequent risk of HIV infection in men and in women.

Co-author on the paper, Dr Lynne Hampson, said: “These results are very exciting since they show that the drug not only preferentially kills HPV-infected non-cancerous cells by re-activating known antiviral defence systems, it is also much less toxic to normal non-HPV infected cells.

“Lopinavir is obviously safe for people to take as tablets or liquid but our latest findings provide very strong evidence to support a clinical trial using topical application of this drug to treat HPV infections of the cervix.”

Standard dose Kaletra treatment in women with HIV is unlikely to show an association with a reduced risk of cervical cancer due to the dose needed to kill HPV-infected cells.

Dr Hampson said: “Our results suggest that for this drug to work against HPV it would be necessary to treat virus-infected cells of the cervix with roughly 10-15 times the concentration that is normally found in HIV-infected patients taking lopinavir as tablets. This implies that, for this treatment to work, it would need to be locally applied as a cream or pessary.”

 

Taken from Aidsmap 9 May, 2011

Posted: May 9, 2011 by Nozizwe (updated June 22, 2011)

Abacavir linked to heart disease, stroke, tenofovir to heart failure, in large U

A large study of US patients with HIV has concluded that people taking abacavir had an increased risk of heart disease and stroke, but also found a modestly increased risk of heart failure in people taking tenofovir.

The study, which analysed patient data from the Veterans Administration Clinical Case Registry, was published this month in the journal AIDS.

There has been controversy for some years over the possible role of abacavir in cardiovascular disease in people with HIV, since the D:A:D cohort study found that recent abacavir treatment increased the risk of heart attack by 90%.

While some cohort studies have found that people who took abacavir as part of their antiretroviral regimen had a higher risk of heart attack, other studies – including a meta-analysis of clinical trials of the drug – found no increased risk of cardiovascular events in people taking the drug.

Less attention has been paid to heart failure, a progressive condition caused by weakening of the heart, attributable both to the same risk factors as heart attack and atherosclerosis, but also to the toxicity of HIV or drugs to the heart muscles.

The study published this month analyses cardiovascular events in 10,931 HIV-infected patients receiving care through Veterans Health Administration hospitals in the United States who started antiretroviral therapy between1997 and 2007, and who had viral load, CD4 count and kidney function data available.

The kidney function data were important, authors noted, because most previous studies have not controlled for an important potential bias: patients with kidney disease may be steered away from tenofovir due to its potential toxic effect to the kidney tubules, and placed instead on abacavir-based treatment. However people with kidney disease are at higher risk of cardiovascular disease, and this could lead to an apparent increase in the risk of cardiovascular events that might not be caused by abacavir.

A previous analysis of the Veterans data, presented at the International AIDS Society conference in 2009, found no elevated risk of heart attack or stroke in patients taking abacavir, in patients treated between 1996 and 2004.

This analysis compared treatment outcomes in 3235 patients treated with abacavir, 4314 treated with tenofovir and 9122 who received regimens containing other antiretroviral drugs.

The average duration of exposure to abacavir was 1.6 years and to tenofovir 1.3 years.

Conditions strongly implicated in the development of cardiovascular disease were common in this cohort: around half smoked, around 40% had high blood pressure, 16-19% had diabetes and one-fifth already had a diagnosis of cardiovascular disease at the time they started either abacavir or tenofovir.

Impaired kidney function was somewhat more common in the abacavir-treated patients compared to tenofovir-treated patients (10% vs 6%).

During 60,588 person-years of follow-up there were 194 cases of heart failure, while in 59,578 person-years of follow-up there were 501 atherosclerotic cardiovascular events.

Abacavir treatment was associated with a 50% increase in the risk of a cardiovascular event when compared to tenofovir or other treatment (13.4 events vs 9.4 events per 100 person years, p<0.01; hazard ratio 1.49 (95% confidence interval 1.09-2.05)), even after controlling for measures of kidney function and changes in kidney function over time.

When different types of cardiovascular event were isolated, abacavir treatment was significantly associated with stroke (2.05, 95% CI 1.00-4.19) but not with other cardiovascular events and duration of exposure or less recent exposure to abacavir were not associated with an increased risk of a cardiovascular event.

Tenofovir treatment was associated with an 82% increase in the risk of heart failure in multivariate analysis (HR = 1.82, 95% CI 1.02 – 3.24, p=0.04) when compared to use of abacavir or other drugs, and the authors report that this association appeared stronger in patients with poorer kidney function (GFR <60 mL/min/1.732 (HR = 3.29, 95% CI 1.39 – 7.76).

Besides the known effect of tenofovir on kidney function, which tends not to be profound in observational studies, the authors ask whether another mechanism might be at work.

They note that tenofovir can cause damage to the lining of the kidney tubules, and so may disrupt both vitamin D activation and correct balance of calcium and phosphate. Renal mineral bone disease, characterised by abnormal metabolism of vitamin D, calcium and phosphate, has been associated with cardiovascular disease, and the authors say that there is an urgent need to determine whether tenofovir treatment might lead to a higher rate of heart failure through this pathway.

The authors caution that their results may not be generalisable to women, who comprised less than 3% of the cohort receiving abacavir or tenofovir.

 

Taken from Aidsmap 9 May, 2011

Posted: May 9, 2011 by Nozizwe (updated June 22, 2011)

HIV and hepatitis C treatment

Twice weekly dosing of pegylated interferon improved early response rates to hepatitis C therapy in a small study of co-infected HIV-positive patients, US investigators report in the online edition of AIDS.

Especially impressive results were seen in African-American patients.

Liver disease caused by hepatitis C is a major cause of illness and death in co-infected patients.

Treatment for hepatitis C is available. Lasting for 48 weeks, it consists of a once-weekly injection of pegylated interferon, which is taken in combination with daily oral ribavirin, dosed according to a patient’s weight. Only a minority of co-infected patients who receive therapy during the chronic phase respond to therapy and new treatment strategies are needed.

Suppression of hepatitis C viral load in the first weeks of treatment is predictive of longer-term outcomes. Investigators therefore wanted to see if providing biweekly doses of pegylated interferon during the first four weeks improved early and longer-term responses.

Their small, randomised study involved 19 co-infected patients. All were infected with hepatitis C genotype 1.

Treatment was provided for 48 weeks and all the patients received weight-based doses of ribavirin.

Patients in the treatment arm were given twice-weekly 180 µg doses of pegylated interferon for the first four weeks, and then switched to once-weekly dosing. Those in the control arm received a once weekly 180 µg dose of pegylated interferon for the duration of the study.

Patients were monitored on seven occasions during the first two weeks of treatment (day 0, 3, 6, 6, 7, 10 and 14), and then on day 21, 28, 42, 56. After this time point, the monitoring was conducted every four weeks until week 72.

African-Americans have a poorer response to hepatitis C treatment than Caucasians, and the investigators were therefore especially eager to see what impact the experimental dose had in this group.

Most (84%) of the patients were male and 54% were African American, and their median CD4 cell count was 483 cells/mm3. Two patients in each arm withdrew from the study because of side-effects, but all received a minimum of three weeks of therapy.

After seven days of treatment, patients who received the experimental dose had a significantly lower hepatitis C viral load than those given the standard dose (median, 3.61 copies/log10 ml vs. 5.59 copies/log10 ml; p = 0.032).

Moreover, a higher proportion of patients receiving biweekly pegylated interferon had a 2 log or greater drop in hepatitis C viral load at week 2, week 4 and week 12  (44% vs. O%; 63% vs. 40% and 71% vs. 50% respectively).

A rapid response to hepatitis C treatment (undetectable viral load after four weeks) was observed in 63% of patients on twice-weekly interferon and 30% of individuals receiving the standard dose. This difference was still present after twelve weeks (63% vs. 44%).

However, at the end of treatment comparable proportions of patients in the two study arms had an undetectable hepatitis C viral load (57% vs. 63%).

Treatment is considered to have achieved a cure if a patient has an undetectable hepatitis C viral load six months after completing therapy (sustained virological response). A total of 57% of patients who received the experimental dose of pegylated interferon had this outcome compared to 50% of individuals who received the drug once a week.

A sub-group analysis showed that the experimental dose was associated with favourable early outcomes  - a 2 log drop in viral load at week 2 and week 4 (60% vs. 0% and 75% vs. 0%; p < 0.05) -  in African Americans. 

Higher trough levels of pegylated interferon were seen in patients who received the twice-weekly dose (p = 0.011).

In addition, patients who received the experimental dose normalised their liver function faster than patients treated with once-weekly interferon. ALT levels remained significantly lower in the patients dosed twice weekly at the end of the study.

Increased frequency of pegylated interferon during the first four weeks of treatment did not increase the risk of side-effects.

“While both groups experienced adverse events commonly associated with interferon-based therapy, the investigational group did not demonstrate significantly more toxicities, which suggests that the biweekly therapy is safe and as equally well tolerated as standard therapy,” comment the investigators.

They conclude, “the results of this pilot study show promise for a more effective therapy particularly for HIV/HCV genotype-1 co-infected African Americans.”

 

Taken from  (HIV Weekly, 4 May 2011)

Posted: May 5, 2011 by Nozizwe

Vitamin D

Vitamin D deficiency is highly prevalent in patients with HIV and is associated with an increased risk of disease progression, investigators from the EuroSIDA cohort report in the online edition of AIDS.

The investigators from Europe, Argentina and Israel found a strong relationship between low levels of the vitamin and an increased risk of all-cause mortality and the development of an AIDS-defining condition. They comment: “vitamin D deficiency therefore represents a new, independent, unfavourable prognostic marker in HIV infection.”

There is a some evidence showing that vitamin D deficiency is linked with a number of serious illnesses in the HIV-negative population, including cancers and heart disease, but the strongest association is between deficiency and bone thinning.

Levels of the vitamin below 10 nanograms per millilitre (ng/ml) are widely accepted as showing deficiency.

A number of studies have demonstrated that vitamin D deficiency is common in patients with HIV. Possible reasons include low levels of sun exposure, poor absorption, kidney or liver impairment, or the interference of antiretroviral drugs with vitamin D metabolism.

Investigators from the EuroSIDA cohort wished to establish the prevalence of vitamin D deficiency among their patients, its risk factors, and its relationship with disease progression.

A total of 1985 patients were involved in the study. Most of the patients (82%) were taking combination antiretroviral therapy.

Vitamin D levels were assessed on entry to the study, and placed into three categories: low (below 10 ng/ml); medium (10 to 30 ng/ml); and high (above 30 ng/ml).

Results showed that 24% of participants had vitamin D deficiency, 65% had moderate levels of the vitamin, and only 11% had vitamin D levels above 30 ng/ml.

“The present results confirm that vitamin D insufficiency or deficiency is frequent in HIV-infected persons,” comment the investigators.

For statistical reasons, the patients were then stratified into three categories (below 12 ng/m; 12 to 20 ng/ml and above 20 ng/ml).

Factors associated with vitamin D levels in the lowest tertile included black race (p = 0.0006), injecting drug use (p = 0.02), heterosexual HIV risk (p = 0.0001), and older age (p = 0.01).

HIV therapy that included a protease inhibitor was associated with a lower risk of vitamin D deficiency (p = 0.001). The investigators note this finding is “of unclear biological relevance”.

Next, the researchers examined the relationship between vitamin D levels and disease progression.

Five years after baseline, 10% of patients with vitamin D in the lowest tertile had developed AIDS, compared to 6% of individuals in the middle group and 5% of patients with the highest vitamin D levels.

Mortality rates also differed according to vitamin D status, and were highest for patients with vitamin D deficiency (11 vs 7 vs 6%).  Rates of non-AIDS-defining events were 9 vs 7 vs 7%.

Low levels of vitamin D were related to poorer outcomes.

Compared to participants with the lowest levels of vitamin D, people in the middle and upper tertiles had a significantly lower risk of progression to AIDS (p = 0.00086 and p = 0.02 respectively).

Similarly, the risk of death was lower for people in the middle and upper tertiles (p = 0.045 and p = 0.003 respectively).

People with the highest levels of vitamin D were also significantly less likely than those with vitamin levels below 12 ng/ml to die of a non-AIDS-related cause.

Adjustment for CD4 cell count and viral load further confirmed that patients with moderate or high levels of vitamin D had a reduced risk of death (p = 0.025 and p = 0.048 respectively).

“A very low [vitamin] D level was associated with events, even in the case of virologically controlled HIV infection and immune restoration,” the authors emphasise.

They conclude: “These results provide strong evidence that vitamin D deficiency is an important cofactor in HIV disease progression, even in the setting of widespread, efficient cART [combination antiretroviral therapy]. Whether the relationship between vitamin D deficiency and events is casual must now be addressed.”

 

Taken from (HIV Weekly, 4 May 2011)

Posted: May 5, 2011 by Nozizwe

HIV and heart problems

People with uncontrolled HIV infection are significantly more likely to suffer heart failure than people without HIV infection, according to results of a large cohort study of US military veterans published this week in Archives of Internal Medicine.

The study adds to the accumulating evidence that untreated HIV infection may increase the risk of heart disease.

Heart failure is a gradual weakening of the heart that leads to increasing breathlessness and weakness, and requires medication or surgery as the condition becomes more severe.

Previous studies have looked at myocardial infarction, stroke or other cardiovascular events. Heart failure is a cardiovascular outcome that may occur for a variety of reasons, including heart attack, high blood pressure, disease of the heart muscle (cardiomyopathy), alcohol or cocaine abuse, and represents a progressive condition that requires active management rather than a one-off event.

The study evaluated heart failure in a large cohort of male US military veterans, and excluded anyone with pre-existing cardiovascular disease or cancer.

A total of 8,846 participants were evaluated, of whom 28.2% were HIV-infected. All participants were part of the Veterans Aging Cohort Study Virtual Cohort.

Participants had a median age of 48 years, and around 39% were African-American.

With regard to risk factors for heart disease those with HIV were more likely to smoke (55% vs 45%, p<0.001), to have a history of cocaine use (21.9% vs 15.7%, p<0.01) or hepatitis C coinfection (30.5% vs 11.4%, p<0.001). HIV-negative participants were more likely to have diabetes (24.8% vs 16.7%, p<0.001) or hypertension (28.8% vs 18.7%, p<0.001).

Rates of alcohol dependence and elevated lipid levels were similar in the two groups, but HIV-positive people had a lower mean body mass.

People with HIV infection were almost twice as likely to experience heart failure (incidence 7.2 vs 4.82 per 1000 person-years of follow-up, hazard ratio 1.81, 95% confidence interval 1.39-2.36).

Among individuals without chronic heart disease or a history of alcohol abuse HIV was second only to hypertension as a risk factor for heart failure, and tended to show a stronger association with heart failure than traditional risk factors such as smoking, high body mass and older age.

Individuals who had a detectable viral load on recruitment to the cohort (HR 2.28 vs HIV-uninfected), or who subsequently experienced viral load rebound after joining the cohort (HR 2.39), had a significantly higher risk of heart failure than those who had an undetectable viral load throughout their follow-up time in the cohort  (HR 1.10) (p> 0.01 and >0.03 respectively).

The authors say that their analysis is limited in its ability to fully quantify any effects of antiretroviral treatment by lack of data on antiretroviral drug regimens and adherence.

The authors suggest that ongoing HIV replication is an important risk factor, but also note that secondary infections of the myocardium (heart muscle) by opportunistic pathogens present in people with HIV, such as cytomegalovirus, Toxoplasma gondii and Cryptococcus neoformans could be responsible for some portion of heart failures.

They say that traditional risk factors for heart failure should not be ignored in people with HIV infection. Age, obesity, hypertension, diabetes, alcohol abuse and African-American race all remained significant predictors of heart failure even after individuals with chronic heart disease were excluded from the analysis, suggesting the extent to which modification of lifestyle factors is advisable in advance of any development of symptomatic heart disease.

“Interventions to minimize the modifiable traditional risk factors, including glycemic and blood pressure control, weight reduction and abstinence from alcohol are prudent strategies that should be emphasized,” the authors conclude.

They say more work is needed to determine whether heart failure in persons with HIV is chiefly systolic or diastolic, and to look at the effects of interventions such as glycemic control and anti-hypertensive medication on the risk of heart failure.

 

Taken from (HIV Weekly, 4 May 2011)

Posted: May 5, 2011 by Nozizwe

Screening for anal cancer

Rates of anal cancer are increased in patients with HIV, and separate research from the US Department of Veterans Affairs has shown that screening for pre-cancerous cell changes in routine HIV care is feasible and acceptable to patients.

Infection with some strains of human papillomavirus (HPV) can cause cell changes in the cervix and anus that can progress to cancer.

The earlier these changes are detected, the better the chance of successful treatment that can prevent the progression to cancer.

The introduction of cervical screening led to a dramatic fall in rates of cervical cancer.

However, even though rates of anal cancer are higher in patients with HIV, few patients are screened for pre-cancerous cell changes.

A total of 160 individuals were invited to participate in the research and 82% agreed.

Screening showed that 52% of patients had abnormal anal cells. This was associated with a lower CD4 cell count.

Results showed the value of screening regardless of a patient’s sexual history. Abnormal anal cells were detected in individuals who said they had never had anal sex.

“In our study abnormal anal cytology was as frequent in patients who denied anal intercourse as in patients with a history of anal intercourse,” comment the authors.

They add, “HIV-infected patients need to know they are at risk of anal cancer, and anal health should be an issue of priority for HIV care providers to discuss with their HIV-positive patients.”

 

Taken from (HIVweekly, April 27, 2011)  

Posted: April 27, 2011 by Nozizwe

First UK use of PrEP for couples hoping to have a child

Pre-exposure prophylaxis is starting to be used in the UK, to help HIV-positive men and their HIV-negative female partners have children together, Yvonne Gilleece told the British HIV Association (BHIVA) conference in Bournemouth last week. Only a handful of couples have used the procedure so far, but there have been no HIV transmissions.

Also this month, other research has shown how couples wishing to conceive value the ‘normality’ that a pregnancy signifies, but find that a medical intervention like sperm washing undermines this normality. When antiretroviral treatment reduces a partner’s viral load to an undetectable level this can enable couples to feel more confident about conceiving through ‘real sex’.

Pre-exposure prophylaxis

Pre-exposure prophylaxis (PrEP) is the use of antiretroviral drugs by HIV-negative people to help prevent infection. Last year an international trial showed that daily PrEP substantially reduced infections in men who have sex with men.

European clinicians have previously described using PrEP as an additional tool, alongside HIV treatment that reduces the HIV-positive partner’s infectiousness, to allow heterosexual couples to have timed intercourse in order to achieve a pregnancy, with a low risk of HIV transmission.

At the BHIVA conference, Dr Gilleece outlined the pre-conception services provided by the Royal Sussex County Hospital in Brighton and Birmingham Heartlands Hospital. These clinics work with both local couples and those who have been referred from other hospitals.

Couples require extensive information, discussion and counselling before proceeding. It is important to explore other options such as sperm washing and adoption, as well as to fully explain the available data on HIV treatment and infectiousness. Moreover, couples need to have a ‘no blame’ attitude and to have considered the worst-case scenario.

Because this use of antiretroviral drugs is unlicensed and a risk of HIV transmission remains, couples must provide written consent before proceeding.

Gilleece noted some of the reasons couples choose to use pre-exposure prophylaxis - they may be unable to obtain NHS funding for sperm washing (particularly if they already have a child) and unable to pay for sperm washing privately. Sperm washing requires travel to London and disruptive procedures, whereas when using PrEP, conception may feel more natural.

However there are a number of situations where the use of PrEP would be inappropriate – when a partner is co-infected with hepatitis, when fertility interventions are required, when HIV viral load is detectable in blood or semen, or when a partner is very anxious about HIV transmission.

The HIV-negative partner is advised to take one or two doses of tenofovir or Truvada (tenofovir and FTC combined in one pill) between 24 and 36 hours before sex, and then another dose one to two hours afterwards. Couples are advised to limit unprotected sex to the days of the month during ovulation (and taught how to tell when the woman was ovulating).

Only five couples have gone through the programme so far. There have been four pregnancies, resulting in one live birth, one pregnancy that is still ongoing and two miscarriages. One couple stopped using PrEP when the male partner had a series of viral load blips (all men had an undetectable viral load on entering the programme). Couples had unprotected sex an average of three times before pregnancy was achieved (minimum one, maximum five).

These numbers are far too small to give any reliable data on safety, but there have been no HIV transmissions.

Gilleece said that these early data – the first from the UK – suggests that the approach is a safe and effective way of reducing risk. Demand for it is likely to increase, but current PrEP trials are not exploring this approach. She said that other UK clinics should only use PrEP in collaboration with more experienced centres, and that data from across the UK should be gathered collectively in order to assess the safety and efficacy of PrEP on a larger scale.

Assessing risk

A separate study of men and women in sero-different couples (where one person has HIV and the other does not) has shed light on how risks and interventions are weighed up when there is a desire to have a child.

Carmel Kelly conducted in-depth, qualitative interviews with six women and four men living in Northern Ireland. Some of the participants were HIV-positive and others were HIV-negative, but each had a partner of a different HIV status. The participants were born variously in Ireland, Africa and Eastern Europe.

For each interviewee, decisions about having children could no longer be taken for granted or made without discussion with clinicians. Biomedical understandings of risk and possibilities became central to their plans for the future. In fact some participants had previously assumed that it would now be impossible to have a child, and dialogue with HIV clinicians helped many understand and believe that having a baby in the context of HIV was relatively safe and normal.

However these feelings could sometimes be challenged by distressing encounters with fertility specialists and other non-HIV clinicians who questioned a person’s aspiration to have a child.

“He [doctor] said, ‘I have to think about the protection for my nurses and the doctors and you also have to think about the protection of your wife’. Now he made me feel that I was a threat to the entire medical staff and my family. And I had gone there for help. I didn’t go there to be told, as if I was a divisive enemy or weapon.”

Participants talked about how having HIV had affected their sex lives and about wanting things to be as ‘normal’ as possible. Several of the men put a particular value on unprotected sex, which was felt to be ‘real sex’.

“I am here trying to cope with treatment, not telling people my diagnosis and now I can’t even have my wife. For how long? A night? Two months? A year? Two years? No. Forever. From now onwards sex is out of the question. I mean real sex. Now that is another prison. Another sentence.”

The women were more likely to find condoms acceptable. They were more likely to enjoy sex when they knew they were protecting their partner from HIV.

For several interviewees, the decision to have a child with their partner was a key step in their relationship and was a sign of normality for each other and for the outside world. One HIV-negative woman explained how her pregnancy would provide a distraction to community members who had suspicions about her partner’s HIV status.

Another interviewee struggled to find the English to explain how fundamental the desire to have a child was to his sense of self.

“Since then I have had that idea of having a baby because I consider myself a human being. I was someone who (my English find it hard) to procreate. When we are healthy, when we are born and grow up we have that idea to procreate because we were procreated... But when I became HIV positive I think it is finished for me. I can’t have anymore. Having one woman, one wife and having healthy kids. These things affect me very much. When I think about it I think I am not useful anymore for people... I take the risk to do it because I want to feel as a man.”

But the same man and his wife were uncomfortable with the idea of sperm washing:

“I talk to the doctors. We discuss, they told me, they showed me the way I could have a baby without harming the baby is [sperm] washing... It is not how people want it. They want to have a baby a normal way, you know. Like my wife, when we discuss, she said, ‘no’, she can’t do this. It is better not having a baby. She born, when she born, she didn’t born that way. All babies she going to have in the future she want to have them the way she was born, normal way, you know.”

Sperm washing involves the man’s sperm being treated in a laboratory before it is artificially inseminated in his partner. The high cost of the procedure means that there can be wrangles with health bodies over payments and availability. Each attempt at a conception (of which there may be several) requires a trip to London.

Another man had considered sperm washing but expressed his preference for a pregnancy “the normal way, without any of the interventions”. It is notable that the reduction of viral load through antiretroviral treatment felt normal to him and was not perceived to be an extra intervention.

“You know they had suggested the various ways of how we could do it and we sat down and we discussed it and thought, ah well, seeing that I have been able to control the virus, and maintaining the viral load we will just do it the normal way, without any of the interventions.”

A number of participants had had unprotected sex on numerous occasions (sometimes including a period before HIV had been diagnosed), and this informed a faith or confidence they had in the possibility of having sexual relations without transmission occurring. This faith had been augmented by a growing awareness of the relevance of medication and viral load to transmission risks.

One HIV-negative woman explained how the transmission risk came to feel unexceptional to her.

“The second time [second pregnancy] it had become quite normal. You know it was not a big deal... You know, having unprotected sex with someone who is HIV-positive to become pregnant. To another person would be, like ‘what, you have done what, are you crazy?’ you know whereas to us now it’s like, you know, yeah, if you want to have another one.”

However her confidence in a low transmission risk applied only to times when she was trying for a baby; unprotected sex was not an option at other times.

Concluding her study, Carmel Kelly says that her findings demonstrate how personal priorities and meanings are central to the negotiation of risk in sexual relationships. Biomedical understandings of risk (including those based on viral load) are balanced against a broader set of expectations, meanings and desires.

 

 

Taken from (Aidsmap 26 April, 2011)

Posted: April 26, 2011 by Nozizwe

Some London clinics may have difficulty meeting drug prescription targets

Some HIV clinics in London may have difficulty conforming to the new targets set for the proportion of patients who are prescribed cost-saving regimens, according to a poster presentation at this month’s BHIVA conference.

The poster, from Guy’s and St Thomas’s Hospital Trust, shows that despite there being a considerable financial incentive involved, the HIV clinic at St Thomas’s Hospital failed to achieve a target of putting at least 80% of new patients on non-nucleoside (NNRTI)-based regimens instead of the more expensive protease inhibitor (PI)-based ones, and documents the reasons.

Background – prescribing changes

The question of which drugs patients are preferentially prescribed became more prominent this month when the London HIV Consortium of the London Specialised Commissioning Group (LSCG) announced that it had agreed with London’s lead HIV consultants that they would prescribe abacavir/3TC (Kivexa) plus efavirenz (Sustiva) as their regimen of first choice for drug-naïve patients, and boosted atazanavir (Reyataz plus Norvir) as their first choice of PI, in preference to more expensive alternatives.

The LSCG has now placed an explanation and presentation on its new prescribing policy on its website – see here.

This has been done as a way of saving approximately £9 million which would otherwise have to be saved by reducing services. London has received no increase in its HIV treatment and care budget this year despite a projection that the number of patients on antiretroviral drugs will grow by at least 5.3%.

Claire Foreman, lead commissioner of the London HIV Consortium, told its Patient and Public Engagement group today that the Consortium pledged that it would not use the ultimate sanction of withholding a Trust’s HIV drug funding if it failed to conform to the new drug prescribing requirements.

Short of this sanction, however, the NHS already has a number of financial rewards schemes designed to induce individual trusts to reach specific targets. One of these is the CQUIN (Commissioning for Quality and Innovation) payment framework, under which trusts get a proportion of their income on condition that they meet certain targets and are penalised if they do not.

The ‘80% NNRTI’ CQUIN was initiated in the financial year 2009-10 by most London HIV clinics. Prescribing NNRTIs rather than PIs saves, on average, £1500 per year per patient. The 80% target also includes patients that have NNRTI resistance, but excludes patients who cannot take NNRTIs for other reasons, such as pregnant women (who cannot take efavirenz) who have high CD4 counts (and so cannot take nevirapine). These are supposed to account for the other 20% of patients.

The Guy’s and St Thomas’s Study

Despite the considerable financial incentives, Guy’s and St Thomas’s only ended up prescribing NNRTIs for 50 out of 80 new patients in the year December 2009 to November 2010. There were another five patients who were excluded from NNRTIs because they had resistance. This meant that only 68.75% of patients met the CQUIN target instead of 80%.

There was no difference in CD4 count between patients given NNRTIs (218 cells/mm3) or not (223 cells/mm3), but four people in the NNRTI-sparing group had AIDS-defining conditions versus one in the NNRTI group.

Of the 25 patients who were offered NNRTI-sparing regimens despite having no drug resistance:

• Six patients were deemed ‘chaotic’ and so were offered PI-based regimens, which are more robust in circumstances of poor adherence;

• Three were women planning pregnancy who had CD4 counts too high for nevirapine;

• Three had working patterns that precluded efavirenz (which is usually taken at night) but could not take nevirapine because their CD4 counts were too high or they had hepatitis B (nevirapine can cause liver failure);

• One was on drugs that interacted with NNRTIs.

This left nine patients who were offered NNRTI-sparing regiments because their drug resistance test had not come back. If clinicians had waited and none of these patients had had resistance, then prescribing NNRTIs would have meant hitting the 80% CQUIN target exactly.

Lead author Selina Singh, however, told aidsmap that there were good clinical reasons for prescribing PIs for most of these nine patients too.

Four patients had AIDS-defining illnesses and their physicians did not feel that delaying ARV treatment was safe.

Two had abnormal liver function; one also had a rash and the other was extremely worried about psychological side effects; in both cases physicians were therefore concerned about NNRTI-related side effects.  

Two patients with low CD4 counts were established on PI-based regimens and there was a delay in sending resistance test results. By this time the patients were established on their regimens and did not wish to switch.

This left one patient who wanted to be on a PI-based regimen because he wanted the same treatment as his partner.

In the vast majority of cases, then, physicians prescribed NNRTI-sparing regimens because they believed there was a clinical need for them.

The authors comment: “Those starting on a PI were more likely to have an AIDS-defining illness. In such acutely-unwell patients, it is often safer to start on a PI than risk [liver] toxicity.”

“This indicates that CQUIN targets are unrealistic for a cohort of patients needing to start antiretroviral therapy,” they conclude.

 

Taken from (Aidsmap 26 April, 2011)

Posted: April 26, 2011 by Nozizwe (updated May 10, 2011)

“Intensive Combination Prevention” proposal for gay men in England

A pilot rollout in England of a new, standardised intensive HIV prevention package for gay men at high risk of HIV infection would include a substudy in which half of them will be offered pre-exposure prophylaxis (PrEP), the 17th British HIV Association (BHIVA) Conference heard in Bournemouth last week.

The proposal, which has been drafted by the Health Protection Agency (HPA) and members of BHIVA, is at an early stage and would need to secure funding from a variety of sources, including local authorities who will now be in charge of public health, to be viable.

The “Intensified Combination Prevention” (ICP) is a package which will involve:

• regular, rather than ad-hoc, attendance at GUM clinics by the target population
• a standardised counselling intervention at each attendance based on motivational interviewing
• and, at 50% of the ten GUM clinics involved, daily oral PrEP using open-label tenofovir/FTC (Truvada).

The pilot phase would last two years.

Background: increasing diagnoses in gay men

Professor Noel Gill, chief epidemiologist of the HPA, spoke of a sense of new urgency in the need to bring down the number of HIV infections diagnosed in gay men and men who have sex with men (MSM) in the UK.

Last year the number of MSM diagnosed with HIV exceeded 3,000 for the first time ever. This represented an 11% jump in the number of new diagnoses in one year, after a couple of years in which infections stayed relatively static, and for the second year running they represented the risk group with the highest number of diagnoses, after a decade in which there were more new diagnoses amongst Africans living in the UK than gay men.

The annual number of new diagnoses in gay men has increased by 41% since 2001. Gay men represent nearly half of all those infected in the UK.

Infections among heterosexuals within the UK also continues to increase and has tripled since 2001; last year's annual total of 1150 represents one-sixth of new diagnoses.

Professor Gill said he had initially hoped that the continuing increase of diagnoses in gay men was due to more coming forward for tests. He had also anticipated that lack of increase in diagnoses seen in 2008 and 2009 might signal that antiretroviral therapy in HIV-positive people was starting to have an effect by bringing down their infectiousness, as has been observed elsewhere. This year’s increase, however, sent a warning signal that so far this did not seem to be the case in the UK.

“I’ve spent eight years expecting diagnoses to go down,” he said, “and it’s clear that we need to do something new”. He estimated that 3,000 new diagnoses represented an additional cost to the NHS of £38 million a year.

Intensified combination prevention

Gill said that the UK’s network of open-access, STI-specific GUM clinics represented a unique environment in which to test both Intensified Combination Prevention (ICP) and PrEP. 

There are 204 GUM clinics in England of which 29 – most of them larger clinics representing nearly half of all patients - are involved in an existing surveillance and research collaboration with the HPA called GUMNET. The cost of involving all 29 clinics in the pilot ICP-and-PrEP intervention would be well in excess of £50 million so the proposal is that ten clinics pilot ICP and that five of them include PrEP as part of the package.

The sole criterion for offering ICP and PrEP is that the patient be a ‘high risk gay man. ‘High risk’ is defined as

• attending with an acute sexually transmitted infection (STI) and/or
• having had unprotected anal sex with a regular partner of positive or unknown status in the last six months and/or
• having had unprotected anal sex with at least one casual partner in the last six months.

Gill said that to roll out this prevention initiative, even in ten clinics, would involve an unprecedented collaboration and pooling of funds between STI and HIV clinicians, the at-risk communities, the new commissioners of public health, medical research groups, and the pharmaceutical industry.

He hoped that pharmaceutical companies would appreciate that this proposal potentially had international implications when it came to demonstrating the feasibility of rolling out PrEP in the real world.

Dr Tony Nardone, the HPA’s specialist in virology, put some more figures on the proposal. The idea is to recall all ‘high risk’ gay men as defined above for routine appointments three and six months after first attendance and then every six months. Men offered PrEP would also attend at months one and nine, requiring two more attendances per year. This is because men taking PrEP would be tested for HIV every three instead of every six months, due to the need to avoid taking PrEP while seroconverting for HIV, and also to discuss any adherence difficulties at an early stage.

As well as the basic testing, counselling and PrEP package, ICP would also offer net-based health promotion and behavioural monitoring and accelerated partner notification.

Nardone said that about 9000 MSM turn up with an acute STI at the GUMNET clinics every year and that if the larger clinics are involved 3600 to 6000 MSM could be enrolled in the two-year pilot of ICP, of which half would be offered PrEP. Annual HIV incidence amongst repeat visitors to GUMNET clinics – excluding those diagnosed with HIV on their first visit - was 1.1%. This should be enough to be able to prove establish efficacy for PrEP if the reduction in infections was the same as in the iPrEx study (43%).

The BHIVA/BASHH position statement

BHIVA and the British Association for Sexual Health and HIV (BASHH), which represents GUM clinicians, are collaborating on writing a Position Statement on PrEP including:

• a review of the PrEP data so far
• appraisal of which populations might benefit from it
• a review of cost-effectiveness models
• the identification of research gaps.

This will be available for community consultation and comment this summer, with the aim of publication at the autumn BHIVA conference in October.

BHIVA’s Sheena McCormack, who is co-ordinating the Position Statement, emphasised that this project would cover all possible populations who might benefit from PrEP and was not restricted to the gay community.

Audience members in the meeting announcing the ICP/PrEP proposal had several comments and queries. Some questioned that ‘treatment as prevention’ was failing to work in the UK. Others emphasised that as much thought and effort needed to be involved in the counselling intervention as PrEP and that psychologists and social researchers must be involved. Finally, the PrEP proposal as it stands is dependent on Truvada being available at no or reduced cost and it was questioned if this would be forthcoming.

 

Taken from (Aidsmap 26 April, 2011)

Posted: April 26, 2011 by Nozizwe (updated April 26, 2011)

Frequency of incarceration associated with risk of poor HIV treatment adherence

Incarceration is associated with poor adherence to HIV therapy among injecting drug users, an international team of researchers report in the May 1st edition of the Journal of Infectious Diseases.

Just one instance of imprisonment increased the risk of sub-optimal adherence to antiretroviral treatment, and the more often a patient was incarcerated then the greater their risk of poor adherence.

“We observed a dose-dependent association between the cumulative burden of incarceration and ART [antiretroviral therapy] nonadherence,” comment the investigators, who believe their study “clearly indicates that increasing number of cycles of imprisonment, release and reincarceration is associated with poorer ART adherence in this population of IDUs [injecting drug users].”

Thanks to modern antiretroviral therapy, many HIV-positive individuals now have a near-normal prognosis. High levels of adherence are needed to achieve the best outcomes.

Good results have been seen in HIV-positive injecting drug users treated with antiretrovirals. However, some drug users have difficulty achieving the high levels of adherence necessary for optimal viral suppression.

Incarceration is common among drug users, and it has been estimated that approximately 10% of HIV-positive individuals are imprisoned each year in the US. Significantly for HIV treatment outcomes, some research had suggested that incarceration is associated with an increased risk of interrupting antiretroviral therapy.

Therefore, a team of Canadian and British investigators sought to estimate the frequency of imprisonment among HIV-positive drug users and the association between incarceration and sub-optimal adherence to antiretroviral therapy.

The study was conducted in Vancouver, British Columbia, and its population included 490 HIV-positive injecting drug users who were enrolled in the AIDS Care Cohort to Evaluate Exposure to Survival Services (ACCESS). Recruitment and follow-up took place between 1996 and 2008.

All the patients were taking antiretroviral therapy, and every six months they were interviewed about their experiences of incarceration.

Adherence was assessed using pharmacy refill records, and was defined as sub-optimal if below 95%. Incarceration was defined as spending at least one night in police custody or a prison of some kind.

The median duration of follow-up was a little under 29 months and the investigators had a total of 2220 person-years of follow-up available for analysis.

Over half (55%) of the patients were imprisoned at least once, and the overall incarceration rate was 52.5 per 100 person years. The median number of incarcerations per patient was three, and there were a total of 1156 incarceration episodes.

During the entire period of the study, the overall adherence rate was 61%, well below the target 95%. Of the 3731 six-month follow-up periods included in the investigators’ analysis, 36% were characterised by sub-optimal levels of adherence.

There was a robust association between experiencing incarceration and poor adherence to HIV therapy.

Compared to individuals with no history of incarceration, those imprisoned on one or two occasions were almost twice as likely to be non-adherent during subsequent follow-up (odds ratio [OR], 1.91; 95% CI, 1.35-2.72).

The risk of sub-optimal adherence increased to 2.85 (95% CI, 1.87-4.33) for patients incarcerated who had three to five experiences of incarceration, and an even higher risk of poor adherence was observed for individuals with five or more episodes of imprisonment (OR = 3.59; 95% CI, 2.12-6.09).

These results remained substantially unaltered when the investigators controlled for sex, cocaine use, engagement in methadone treatment programmes, duration of HIV therapy and viral load.

Modern combinations of antiretrovirals can achieve good results with adherence rates of approximately 85%. However, the investigators found that increased frequency of incarceration was still associated with a greater risk of treatment non-compliance using this definition of adherence.

“Because of the tight link between nonadherence and HIV disease progression, our findings have direct relevance to public health efforts to reduce AIDS-related morbidity and mortality and continued viral transmission,” comment the authors.

They conclude, “given the importance of correctional facilities in shaping the health of vulnerable HIV-positive individuals, our findings should spur efforts to reform the delivery of in-prison HIV care and ease transitions to noncorrectional environments.”

 

Taken from (Aidsmap 26 April, 2011)

Posted: April 26, 2011 by Nozizwe

Additional dose of hepatitis B vaccine improves response in patients with HIV

Hepatitis B vaccination consisting of four doses produces a better response in HIV-positive patients than the standard three-dose vaccination schedule, French investigators report in the April 13th edition of the Journal of the American Medical Association.

An especially good response to vaccine was observed in patients who received four intramuscular 40 μg injections (double the standard dose). Patients who received four 4 μg injections under the skin were also more likely to develop protective antibodies than individuals who received the standard three intramuscular injections of 20 μg of the vaccine.

Only one serious side-effect was possibly associated with the experimental vaccination schedules, but overall they appeared safe.

Hepatitis B is a major cause of liver disease in patients with HIV, and all HIV-positive individuals are recommended to be vaccinated against the infection.

Response rates to the vaccine vary between 18% and 72% in patients with HIV, much lower than the 90% rate observed in the general population.

Alternative vaccination schedules and doses are therefore being investigated as ways of improving response rates in patients with HIV.

Researchers in France designed a phase 3, open-label randomised study to investigate three different vaccination strategies.

Patients in the first arm of the study were received the standard 20 μg dose of the vaccine via intramuscular injection on three occasions (day 0, week 4, week 24).

Individuals in the second arm were treated with a 40 μg intramuscular dose on four occasions (week 0, week 4, week, 8, week 24).

The third arm of the study involved patients who were vaccinated using a 4 μg dose. This was administered by four injections under the skin (day 0, week 4, week 8, and week 24).

Antibody responses at week 28 were compared between the three groups of patients, and information was also gathered on safety.

A total of 437 patients were recruited to the study between June 2007 and October 2008. All had a CD4 cell count above 200 cells/mm3 and there were no significant differences between the three study arms.

Overall, a vaccination response was observed in 65% of patients. However, rates differed significantly between the three arms of the study.

Two-thirds of patients who received the standard three doses of the vaccine developed antibodies to hepatitis B. This compared to 86% of patients who received four intramuscular injections of  the 40 μg dose (p < 0.001 vs. standard dosing), and 79% of individuals vaccinated with the 4 μg intradermal dose on four occasions (p = 0.02 vs. standard dosing).

A high-level antibody response was observed in 41% of patients in the first study arm, 74% of patients in the second arm (p < 0.01 vs. arm 1), and 44% of individuals in arm 3 (p = 0.06 vs. standard dosing).

At week 28, mean antibody titres were 55 miu/ml among patients who received the 20 μg dose on three occasions; 795 miu/ml for patients treated with the 40 μg intramuscular dose on four occasions (p < 0.001 vs. arm 1); and 104 miu/ml for patients in arm 3 of the study (p = 0.05  vs. arm 1).

Statistical analysis confirmed that both vaccination schedules involving four doses were associated with a better response compared to the standard schedule (40 μg = AOR, 3.58; 95% CI, 1.92-6.67; 4 μg = AOR, 2.09; 95% CI, 1.18-3.68).

Each 100 cell increase in baseline CD4 cell count was associated with a significant enhancement in response (AOR = 1.12; 95% CI, 1.00-1.26), and women were more likely to develop protective antibodies than men (AOR = 2.03; 95% CI, 1.11-3.73).

Smoking and a detectable viral load were both associated with poorer outcomes.

Overall, the vaccination schedules involving four doses appeared safe, and did not have an adverse impact on either CD4 cell count or viral load. The most commonly reported side-effects were fever, nausea or injection-site reaction.

However, one patient in the 40 μg arm developed severe cytolysis, which the investigators concluded was “possibly” related to the vaccine.

“In a large randomized controlled trial, both the 4 intramuscular double-dose regimen and the 4 intradermal low-dose regimen improved serological response in comparison with standard hepatitis B vaccine in adults with HIV infection with CD4 cell counts of more than 200 cells/μl,” conclude the investigators.

 

Taken from (Aidsmap 26 April, 2011)

Posted: April 26, 2011 by Nozizwe

High rate of liver fibrosis progression in HIV-positive patients

HIV-positive patients have a “significant” risk of experiencing progression of liver fibrosis even without hepatitis co-infection, Italian investigators report in the May 1st edition of Clinical Infectious Diseases.

All the patients in the prospective, observational study were taking antiretroviral therapy, and none were co-infected with hepatitis B or C.

Depending on the method of assessment, rates of progression ranged between 8% and 31%.

A higher CD4 cell count was protective against fibrosis, as was control of viral load, and the investigators believe that this has implications for the debate about the best time to start antiretroviral therapy. “The positive impact of the control of HIV infection suggests that early initiation of HAART [highly active antiretroviral therapy] may provide an opportunity to prevent liver fibrosis progression.”

Liver disease is now a major cause of illness and death in patients with HIV. Co-infection with hepatitis B or C is responsible for much of this disease, but there is little information about the incidence and risk factors for liver fibrosis in HIV-positive patients who do not have these co-infections.

Therefore investigators in northern Italy monitored liver health in 1112 HIV-mono-infected patients who started antiretroviral therapy between 1996 and 2006.

Two validated methods were used to assess liver fibrosis. These were the FIB-4 score, which is calculated using ALT (alaine aminotranserase), and AST (aspartate aminotransferse) levels (both assessments of liver function), platelet count and age; and the AST-to-platelet ration index (APRI). The investigators calculated the concordance between these methods of assessment.

Almost two-thirds (65%) of patients were men, median baseline age was 38 years, and 50% had a CD4 cell count below 200 cells/mm3 when they started HIV therapy. A quarter of patients took a combination of drugs that included a “d” drug (ddC, ddI, d4T), which have been associated with an increased risk of liver toxicity.

For both FIB-4 and APRI, the patients were placed into one of three groups. At baseline, 81% of patients belong to FIB-4 and APRI groups 1 and 2, indicating either no or mild fibrosis. Concordance between the assessment methods was moderate (kappa value, 0.573; 95% CI, 0.524-0.623).

Patients were followed for a median of 2249 days.  The investigators were especially interested to see if patients experienced a worsening of fibrosis during this period that resulted to their transition to a higher grouping.

When the FIB-4 method of assessment was used, 24% of patients were found to have some worsening in fibrosis. This provided an incidence of 0.064 per 100 person years of follow-up. Transition to a higher group was observed in 8% of patients, an incidence rate of 0.018 per 100 person years.

Using APRI scores, the investigators found liver fibrosis progression in 31% of patients, an incidence of 0.099 per 100 person years of follow-up. Analysis also showed that 12% of patients had transition to a higher group, an incidence rate of 0.028 per 100 person years.

However, worsening of fibrosis was often transitory, and 45% of patients reverted to a lower FIB-4 class, with 52% of individuals reverting to a lower APRI class.

Progression to a class 3 FIB-4 score occurred in 6% of patients (incidence 0.013 per 100 person years), and 8% of patients progressed to APRI class 3 (incidence 0.018 per 100 person years).

Baseline factors associated with progression to higher classes were assessed for both FIB-4 and APRI.

For both FIB-4 and APRI they included more advanced fibrosis on entry to the study (p = 0.004 and p = 0.007 respectively).

Older age (< 0.01) and injecting drug use (p = 0.031) were both associated with a worsening of FIB-4 class, and male sex (p = 0.018) and gamma-GT score (p = 0.015).

Progression to class 3 as associated with baseline fibrosis values for both methods of assessment (both p < 0.01), as well as older age for FIB-4 (p = 0.023).

Starting HIV therapy with a higher CD4 cell count was protective against the progression of fibrosis, as was control of viral load. Sensitivity analysis showed that therapy that included a “d” drug was associated with transition to a higher fibrosis class (FIB-4, p < 0.001; APRI, p = 0.015).

“This study demonstrated that HIV-mono-infected patients display a significant risk of liver fibrosis progression,” comment the investigators.

They recommend, “FIB-4 and APRI should be used to identify patients who are most at risk and who need further clinical work…and more proactive counselling to modify dangerous behaviours (such as alcohol abuse).”

The authors conclude, “our results suggest the benefit of earlier HAART initiation for liver fibrosis in HIV-monoinfected patients, provided that the most dangerous [“d”] drugs are avoided.”

 

Taken from (Aidsmap 26 April, 2011)

Posted: April 26, 2011 by Nozizwe (updated April 26, 2011)

Starting HIV treatment when CD4 cell count dips below 500 improves AIDS

Patients who start antiretroviral therapy when their CD4 cell count dipped below 500 cells/mm3 are less likely to develop an AIDS-defining illness than individuals who start treatment with a CD4 cell count of 350 cells/mm3, an international team of investigators report in the Annals of Internal Medicine.

However, initiating HIV treatment with a CD4 cell count of approximately 500 cells/mm3 did not reduce the risk of all-cause mortality.

“If the goal is to prevent AIDS-defining illness or death, our findings support cART [combination antiretroviral therapy] initiation once the CD4 cell count decreases below 500 cells/mm3,” comment the investigators.

Importantly, the investigators did not gather information on the impact of earlier treatment on the risk of serious, but non-fatal, non-AIDS related illnesses.

The authors of an accompanying editorial suggest that the results of the study should be treated with “caution,” and that doctors should have “frank conversations with their patients about what we do and what we don’t know about starting cART.”

Nevertheless, results of the study will undoubtedly inform the debate about the best time to start antiretroviral therapy.

Treatment guidelines in Europe currently recommend that AIDS-free patients should start therapy when their CD4 cell count is in the region of 350 cells/mm3. However, US guidelines advocate treatment when an individual’s CD4 cell count falls under 500 cells/mm3.

Large randomised trials are currently underway to try and determine the optimum time to start HIV therapy. However, their results are not expected for several years. Because of this continuing uncertainty investigators from the HIV-CAUSAL Collaboration undertook a prospective observational study involving approximately 21,000 adult patients enrolled in cohorts in Europe and the US.

All the patients had a CD4 cell count above 500 cells/mm3 when they entered the study, and none had developed an AIDS-defining illness. The patients were recruited between 1996 and 2009. At the time of entry to the study, the patients had a median CD4 cell count of 660 cells/mm3.

The risk of all cause mortality and the risk of AIDS-related illness or death was compared between patients who started HIV treatment when their CD4 cell count was 500 cells/mm3 or above; between 350-499 cells/mm3; 200-349 cells/mm3; and below 200 cells/mm3.

A total of 390 patients developed an AIDS-defining illness or died before their CD4 cell count fell below 500 cells/mm3. HIV therapy was started by 2893 patients when their CD4 cell count was above 500 cells/mm3, and 9296 maintained a CD4 cell count above this level without the need for treatment.

The remaining 8292 patients experienced a fall in their CD4 cell count to below 500 cells/mm3 after a median of nine months.

There was no evidence that starting HIV therapy at CD4 cell counts around 500 cells/mm3, or 350 cells/mm3 significantly reduced the risk of all-cause mortality compared to initiating treatment at a CD4 cell count of 200 cells/mm3. This was equally low for all patients.

However, there was clear evidence that starting therapy at higher CD4 cell counts reduced the risk of AIDS-related illnesses or death.

Compared to patients who started treatment when their CD4 cell count fell below 500 cells/mm3, individuals initiating therapy when their CD4 cell count was below 350 cells/mm3 were 38% more likely to develop AIDS (hazard ratio [HR], 1.38; 95% CI, 1.23-1.56). Furthermore, patients who first took therapy when their CD4 cell count was below 200 cells/mm3 were 90% more likely to develop an AIDS-defining illness (HR = 1.90; 95% CI, 1.67-2.15).

Five-year survival rates were 98% for patients with a CD4 cell count around 500 cells/mm3, 98% for patients with a CD4 cell count around 350 cells/mm3 and 97% for individuals with a CD4 cell count of approximately 200 cells/mm3. AIDS-free survival rates were 92%, 92% and 88% respectively.

The investigators calculated that “approximately 48 patients would need to initiate cART when their CD4 cell count decreased below 500 cells/mm3 rather than 350 cells/mm3 to prevent 1 new case of AIDS-defining illness or death during the first 5 years.”

They add, “however, we estimated little change in all-cause mortality rates between the 500-350 threshold.”

Heart, kidney, and liver disease are now important causes of illness among people with HIV. The investigators acknowledge that a limitation of their study was lack of information on “serious nonfatal events other than AIDS-defining illnesses.”

The authors of the accompanying editorial comment that the study “is a robust, carefully performed analysis that supports the presence of a graded benefit of cART even when the risk for AIDS is low.”

However, they add, “the continuing HIV epidemic and tightening of resources requires that we clarify the absolute benefits, risks and costs of expanding the indications for cART.”

 

Taken from (Aidsmap 26 April, 2011)

Posted: April 26, 2011 by Nozizwe (updated April 26, 2011)

Room for improvement in quality of diabetes care provided to veterans with HIV

The quality of diabetes care provided to HIV-positive patients is good, but there is room for improvement, investigators from the US Department of Veteran’s Affairs report in the May edition of AIDS Patient Care and STDs.

Using the Healthcare Effectiveness Data and Information Set (HEDIS) Comprehensive Diabetes Care (CDC) measures, the researchers evaluated seven aspects of the care provided to over 3000 HIV-positive patients with diabetes.

The results were compared to the care provided by the Department of Veteran’s Affairs (VA) to HIV-negative diabetic patients, as well as the care provided by other public and private facilities.

“VA performance rates on the HEDIS CDC measures for HIV-infected patients with diabetes are generally high but slightly lower than the general VA diabetes population, which suggests room for improvement,” comment the investigators.

Effective antiretroviral therapy has transformed the prognosis of many HIV-positive patients. Diseases of ageing, such as diabetes, are an increasingly important cause of illness and death in patients with HIV. The routine care for HIV-positive patients should now include screening for these diseases.

Investigators wished to assess the quality of diabetes care provided to HIV-positive patients who received their care from the VA.

In 2009, over 100 VA facilities provided free care to over 24,000 HIV-positive individuals, of whom approximately 20% had diabetes. The current analysis included 3006 individuals.

The investigators calculated the proportion of these patients who in 2009 received the standard of care recommended by HEDIS CDC.

Several areas of care were assessed:

1. HbA1c testing: the percentage of patients who had a haemoglobin A1c test.

2. HbA1c poor control: the percentage of patients who had a HbA1c result greater than 9% on their last test.

3. LDL screening: the percentage of patients who had their LDL cholesterol monitored.

4. LDL control: the proportion of patients who had LDL cholesterol below 100 mg/dl in their latest test.

5. Blood pressure control: the percentage of patients who had blood pressure below 140/90.

6. Eye examination: the proportion of patients who had an eye test to screen for diabetic renal disease.

7. Renal monitoring: the percentage of patients who had tests to screen for kidney disease.

Performance was also assessed according the number of patients with HIV/diabetes which each centre looked after.

Overall, the standard of care provided by the VA for HIV/diabetes patients was good, and 91% of patients had a haemoglobin test, 93% had their LDL cholesterol measured, 78% had an eye examination, and 87% had their kidney function monitored.

However, the level of screening varied between centres and was as low as 63% at some smaller centres, but larger facilities often screened all their patients.

The overall level of screening was slightly lower than that provided to HIV-negative patients with diabetes within VA facilities (haemoglobin testing, 98%; LDL screening, 96%; eye exam, 88%; kidney function testing; 95%). However, it was comparable, or better than that provided by Medicare, Medicaid or commercial facilities.

Outcomes were also good for patients with HIV/diabetes. LDL cholesterol was controlled by 57% of patients and 74% had blood pressure control. These results were comparable to those of Medicare, Medicaid and commercial patients. However, they were slightly poorer than outcomes for HIV-negative diabetic patients at VA centres (LDL control, 69%; blood pressure control, 80%).

“Attention needs to be focused on the quality of general medical care for this [HIV/diabetes] population,” comment the investigators.

They conclude: “The fact that some large facilities were able to achieve high performance rates on multiple CDC measures demonstrates that extremely high performance can be achieved and is a reasonable expectation at all facilities.”

 

 

Taken from (Aidsmaap 26, April 2011)

Posted: April 26, 2011 by Nozizwe (updated April 26, 2011)

Study of HIV drug for prevention in women closes, judged unlikely to show effect

A large study of pre-exposure prophylaxis (PrEP) in women is to close after investigators concluded that even if it carries on to its originally planned conclusion, the FEM-PrEP trial is highly unlikely to show a significant protective effect of Truvada (tenofovir and FTC) against HIV infection in this population.

Trial organiser Family Health International stressed in a statement on April 18 that it would be premature to conclude that PrEP did not work in this trial population, and that more analyses will be needed in order to determine what effect, if any, taking Truvada had on a woman’s risk of acquiring HIV during this study.

Pre-exposure prophylaxis is the daily use of antiretroviral drugs by HIV-negative people to prevent HIV infection. Several animal studies and one large randomised trial in men who have sex with men (see below) have shown that Truvada can reduce the risk of infection.

The FEM-PrEP study recruited 1951 HIV-negative women aged 18 to 35 at risk of HIV infection in South Africa, Kenya and Tanzania. Women were randomised to receive daily oral Truvada (tenofovir and FTC in one pill) or placebo. Family Health International says that around 90% of women enrolled were retained in the study, and took the study drug for approximately 12 months.

Among all trial participants the approximate annual rate of new HIV infections was 5% per year, and a total of 56 new infections had been recorded by February 18 2011. These were equally distributed between the Truvada and placebo groups.

Follow-up for each participant was due to last 52 weeks, and the trial was designed to recruit 3900 women.

The decision to halt recruitment at this point indicates that the Independent Data Monitoring Committee which scrutinises the trial has come to the conclusion that even if another 2000 women were to be enrolled onto the trial and followed for 52 weeks, it is highly unlikely that any protective effect of Truvada that might emerge in this group would be enough to demonstrate a statistically significant benefit overall.

This might be because the magnitude of effect seen in the first 1951 women was somewhat too small to be statistically significant, or because there was no substantial difference, and more analysis of the trial data will be needed.

In particular it is unclear whether the women in the two study arms had a similar total exposure to their assigned study medication: an equal number of infections at month 12 may not translate into an equal rate of infection, because women in one group may have a higher number of total months covered by study medication.

It is unclear if adherence might explain the apparent lack of effect in this study. Overall adherence was reported to be 95%, but at this stage FHI is unable to report any differences in adherence between study arms, differences in adherence over time or differences in adherence according to the adherence measures used.

The FEM-PrEP study employed regular reviews of participant adherence to identify any problems, and also measured participant blood levels of antiretrovirals to check on the correlation between self-reported adherence, pill counts and actual drug consumption.

 

Taken from (Aidsmap 26 April, 2011)

Posted: April 26, 2011 by Nozizwe (updated May 10, 2011)

HIV and the liver

HIV-positive patients have a “significant” risk of experiencing progression of liver fibrosis even without hepatitis co-infection, Italian investigators report in the May 1st edition of Clinical Infectious Diseases.

All the patients in the prospective, observational study were taking antiretroviral therapy, and none were co-infected with hepatitis B or C.

Depending on the method of assessment, rates of progression ranged between 8% and 31%.

A higher CD4 cell count was protective against fibrosis, as was control of viral load, and the investigators believe that this has implications for the debate about the best time to start antiretroviral therapy. “The positive impact of the control of HIV infection suggests that early initiation of HAART [highly active antiretroviral therapy] may provide an opportunity to prevent liver fibrosis progression.”

Liver disease is now a major cause of illness and death in patients with HIV. Co-infection with hepatitis B or C is responsible for much of this disease, but there is little information about the incidence and risk factors for liver fibrosis in HIV-positive patients who do not have these co-infections.

Therefore investigators in northern Italy monitored liver health in 1112 HIV-mono-infected patients who started antiretroviral therapy between 1996 and 2006.

Two validated methods were used to assess liver fibrosis. These were the FIB-4 score, which is calculated using ALT (alaine aminotranserase), and AST (aspartate aminotransferse) levels (both assessments of liver function), platelet count and age; and the AST-to-platelet ration index (APRI). The investigators calculated the concordance between these methods of assessment.

Almost two-thirds (65%) of patients were men, median baseline age was 38 years, and 50% had a CD4 cell count below 200 cells/mm3 when they started HIV therapy. A quarter of patients took a combination of drugs that included a “d” drug (ddC, ddI, d4T), which have been associated with an increased risk of liver toxicity.

For both FIB-4 and APRI, the patients were placed into one of three groups. At baseline, 81% of patients belong to FIB-4 and APRI groups 1 and 2, indicating either no or mild fibrosis. Concordance between the assessment methods was moderate (kappa value, 0.573; 95% CI, 0.524-0.623).

Patients were followed for a median of 2249 days.  The investigators were especially interested to see if patients experienced a worsening of fibrosis during this period that resulted to their transition to a higher grouping.

When the FIB-4 method of assessment was used, 24% of patients were found to have some worsening in fibrosis. This provided an incidence of 0.064 per 100 person years of follow-up. Transition to a higher group was observed in 8% of patients, an incidence rate of 0.018 per 100 person years.

Using APRI scores, the investigators found liver fibrosis progression in 31% of patients, an incidence of 0.099 per 100 person years of follow-up. Analysis also showed that 12% of patients had transition to a higher group, an incidence rate of 0.028 per 100 person years.

However, worsening of fibrosis was often transitory, and 45% of patients reverted to a lower FIB-4 class, with 52% of individuals reverting to a lower APRI class.

Progression to a class 3 FIB-4 score occurred in 6% of patients (incidence 0.013 per 100 person years), and 8% of patients progressed to APRI class 3 (incidence 0.018 per 100 person years).

Baseline factors associated with progression to higher classes were assessed for both FIB-4 and APRI.

For both FIB-4 and APRI they included more advanced fibrosis on entry to the study (p = 0.004 and p = 0.007 respectively).

Older age (< 0.01) and injecting drug use (p = 0.031) were both associated with a worsening of FIB-4 class, and male sex (p = 0.018) and gamma-GT score (p = 0.015).

Progression to class 3 as associated with baseline fibrosis values for both methods of assessment (both p < 0.01), as well as older age for FIB-4 (p = 0.023).

Starting HIV therapy with a higher CD4 cell count was protective against the progression of fibrosis, as was control of viral load. Sensitivity analysis showed that therapy that included a “d” drug was associated with transition to a higher fibrosis class (FIB-4, p < 0.001; APRI, p = 0.015).

“This study demonstrated that HIV-mono-infected patients display a significant risk of liver fibrosis progression,” comment the investigators.

They recommend, “FIB-4 and APRI should be used to identify patients who are most at risk and who need further clinical work…and more proactive counselling to modify dangerous behaviours (such as alcohol abuse).”

The authors conclude, “our results suggest the benefit of earlier HAART initiation for liver fibrosis in HIV-monoinfected patients, provided that the most dangerous [“d”] drugs are avoided.”

 

Taken from (HIV Weekly, 20 April 2011)

Posted: April 21, 2011 by Nozizwe (updated April 21, 2011)

HIV treatment – side-effects of atazanavir

Studies presented at last week’s British HIV Association (BHIVA) conference found that kidney stones were four times more common in people taking the protease inhibitor atazanavir than in people taking other drugs. However they were still relatively uncommon – about one case in 50 patients who were being investigated for possible kidney stones turned out to have them.

A parallel study found a significant association between atazanavir and signs of renal failure, though it also found associations between impairment and other protease inhibitors too.

Atazanavir and kidney stones

In the first study Neesha Rockwood and colleagues from the Chelsea and Westminster Hospital in  west London did a retrospective case note review of patients attending the clinic between May 2006 and February 2010, singling out those who had had an abdominal X-ray or CT scan, a renal ultrasound scan, or an intravenous urogram (in which a contrast medium is injected and then x-rays are taken of it being excreted via the urinary system). These four procedures indicate that kidney stones are being investigated as a possible diagnosis.

She only included in this study patients who underwent one of the above investigations and were taking either the non-nucleoside drug (NNRTI) efavirenz (Sustiva, and in Atripla) or one of the protease inhibitors (PIs) atazanavir, lopinavir or darunavir (Reyataz, Kaletra, Prezista).

There have been case reports of kidney stones in patients taking atazanavir and analysis of these stones showed that they consisted of drug that has dissolved out of urine: atazanavir is less soluble in alkaline fluids, which is why it must also not be taken with antacids.

A sub-analysis excluded people with previous exposure to the PI indinavir (Crixivan), which is now hardly used because of its tendency to cause kidney stones. In all over 6,000 patients’ notes were reviewed. Of these 1206 people had taken atazanavir, 2803 efavirenz, 828 lopinavir and 818 darunavir, and 206 had previously taken indinavir.

Two per cent of patients taking atazanavir developed kidney stones, at an annual rate of 0.73% of patients per year (an annual event rate of one case per 137 patients). In contrast 0.54% of patients on the other three drugs developed kidney stones, an event rate of 0.19% or one event per 526 patients.

When patients with previous indinavir exposure were excluded, this brought the percentage of patients with kidney stones on atazanavir to 1.5%, with an annual event rate of 0.46% (one in 217 patients a year). The annual event rate in patients on the other three drugs who had not taken indinavir was 0.12% (one in 833 patients a year).

This meant that patients on atazanavir were 3.85 times as likely to get kidney stones as patients on the other drugs, and although excluding previous indinavir users brought the rates down, the relative difference remained the same.

Patients on darunavir were somewhat more likely to get kidney stones than patients on lopinavir or efavirenz (annual event rates 0.45%, 0.19% and 0.15% respectively).

Patients who had kidney stones were ten times more likely than others to have histories of chronic renal impairment and their levels of the liver waste product bilirubin (which causes jaundice, another side-effect associated with atazanavir) were on average twice as high.

Dr Rockwood said her study probably underestimated the prevalence of kidney stones in patients as some stones were transparent to X-rays and cases in patients who had transferred from other hospitals could have been missed. Atazanavir could have consequences after it was stopped: in one case, a kidney stone containing atazanavir was found in a patient who had stopped the drug 21 months previously.

Protease inhibitors and renal impairment

In a second study, this time of atazanavir’s effect on the kidneys’ ability to filter waste products, the same team found a 52% increased risk of this kind of chronic kidney disease in patients on atazanavir compared to the whole patient group. However this was lower than the risk associated with lopinavir (69% increased risk) and there was some association with darunavir use too, though this became statistically insignificant in multivariate analysis.

Chronic kidney disease was defined as an estimated glomerular filtration rate (eGFR) of less than 60 millilitres per minute per 1.72m2. EGFR is based on levels of the waste product creatinine in the blood and defines the amount of blood the kidneys are able to filter.

This study assessed the rate of kidney impairment in patients prescribed the same four drugs as in the previous study. Out of 2115 patients (78% male, 60% with an undetectable viral load) prescribed these therapies, 386 (18%) developed renal impairment as defined above.

Women were over 50% more likely to develop renal failure, and older patients considerably more likely, as seen in other studies (kidney failure becomes more frequent with age). Patients taking atazanavir, darunavir or lopinavir were, respectively, 27%, 53% and 71% more likely to develop kidney failure. Other risk factors included a history of tenofovir use (68% more likely) and chronic hepatitis B infection (21% more likely).

The risk associated with current tenofovir use appeared to accumulate with time (9% raised risk for each year on tenofovir).

Viral load or CD4 count at baseline, ethnic origin and hepatitis C co-infection were not associated with kidney failure.

Patients currently taking efavirenz had a 40% reduced risk of renal impairment compared with the average patient, though this advantage disappeared if they stopped efavirenz.

In multivariate analysis, taking lopinavir was associated with a 69% higher risk of kidney impairment than taking efavirenz. Patients taknig atazanavir had a 52% higher risk of renal impairment than patients taking efavirenz.. The risk with darunavir (versus efavirenz) was raised 31% but this became statistically non-significant (i.e.