US approval of drug for HIV prevention welcomed cautiously in UK

via Pink News, by Stephen Gray

The decision by US authorities to approve the anti-retroviral drug Truvada for groups at risk of contracting HIV has been cautiously welcomed in the UK.

The US Food and Drug Administration approved Truvada for pre-exposure prophylaxis (PrEP), to help prevent HIV infection amongst those at very high risk.

the FDA emphasised the need for other prevention methods, such as safe sex practices, risk reduction counselling and regular HIV testing.

FDA commissioner Margaret A Hamburg said it was an “important milestone” in the fight against HIV.

She said: “Every year, about 50,000 US adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease.

“New treatments as well as prevention methods are needed to fight the HIV epidemic in this country.”

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Studies Show that PrEP is an Acceptable HIV Prevention Strategy in UK's Gay Population

via AIDSmap.com, by Roger Pebody

Pre-exposure prophylaxis (PrEP) would be an acceptable HIV prevention strategy for large numbers of gay, bisexual and other men who have sex with men in major UK cities, according to two studies presented to the British HIV Association (BHIVA) conference in Birmingham this week.

The conference also heard details of a small pilot PrEP study, likely to start recruiting later this year.

A cross-sectional survey of 842 HIV-negative gay and bisexual men, recruited at bars, clubs and saunas in London, suggested that half the respondents would be interested in taking PrEP.

Respondents were given information about pre-exposure prophylaxis and asked: “If PrEP were available, how likely is it that you would take a pill (oral dose) on a daily basis to prevent HIV infection?”.

Half said yes, with 16% saying they were likely to take PrEP and 34% saying they were very likely to. Men interested in PrEP were slightly more likely to be under the age of 35 (AOR adjusted odds ratio 1.58), have attended a sexual health clinic in the past year (AOR 1.59) and to have previously taken post-exposure prophylaxis (PEP) (AOR 1.96). After statistical adjustment, various measures of risky sex were no longer associated with interest in PrEP.

In this survey, 17 men (2.1% of those answering the question) said that they had previously taken antiretroviral drugs to reduce their risk of HIV infection.

Secondly, clinicians at the Manchester Centre for Sexual Health surveyed HIV-negative men attending their service who reported unprotected receptive anal intercourse. Of the 121 men who responded, 36% said they would be “very willing” to take PrEP while only 14% said they would not take the treatment. Daily dosing was perceived as a better option by four fifths of respondents – just one fifth would prefer taking a dose before sexual activity.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

BHIVA Reports on the Need for Additional PrEP Studies

via AidsMap.com, by Gus Cairns

A position statement by the British HIV Association (BHIVA) and the British Association for Sexual Health and HIV (BASHH) has concluded that as yet the data on the efficacy of pre-exposure prophylaxis (PrEP) is not compelling enough for it to be offered to patients on demand, and that it should only be prescribed in the context of a clinical research study until more data on its efficacy is gathered.

The BHIVA/BASHH position contrasts with that of the US Centers for Disease Control, which issued guidance for doctors prescribing PrEP to patients last year.

The two UK organisations, which represent HIV and STI healthcare workers respectively, conducted a consultation on PrEP last year which included in-person and telephone conferences with a variety of UK treatment and prevention stakeholders in the UK (including NAM), and the creation of an ongoing PrEP Working eGroup.

The finalised position statement notes that in 2010 there was the highest-ever number of new HIV infections in gay men in the UK (over 3000, 81% acquired here) and adds that this “continued increase in infections...underscores the urgent need to...rethink our overall strategy for HIV prevention at a time when the NHS is undergoing change.”

It also however notes that the data on the efficacy of PrEP has so far been widely disparate (see Aidsmap reports on the iPrEx, PartnersPrEP, TDF2, FemPrEP and VOICE trials), in contrast to convincing evidence both for the efficacy of condoms when used consistently and correctly and of treatment as prevention.

It also notes that these are many unanswered questions in the case of PrEP: will it be affordable and cost-effective? Will it increase the likelihood of drug resistance? Are there long-term toxicity concerns for HIV-negative people taking it? And will it induce people to abandon condom use? It also notes there has never been a systematic evaluation of behaviour-change programmes in the UK, also in contrast to the US.

It concludes that “it is imperative to gather [more] evidence for the value of PrEP in the UK” and that therefore “We recommend that ad hoc prescribing is avoided, and that PrEP is only prescribed in the context of a clinical research study”. Until then, “regular HIV testing, the diagnosis and treatment of other STIs, and intensive health promotion activities...should be implemented in preference to PrEP.”

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Model shows excellent prognosis for UK gay men with HIV

via aidsmap, by Michael Carter

New UK research provides further evidence of the dramatic impact of antiretroviral therapy on the prognosis of HIV-positive patients. Published in the online edition of AIDS, a simulated model showed that a non-smoking, 30-year-old gay man, whose HIV is diagnosed promptly, could expect to live until he is 78 years of age. A gay man who smoked, but whose HIV was detected early, had a life expectancy of 75 years.

The model also showed that late diagnosis of HIV cut life expectancy. Nevertheless, it showed the clear benefits of HIV therapy in these circumstances. A gay man whose HIV was detected when his CD4 cell count was just 140 cells/mm3 could still expect to live until he was 71.5 years old.

“Predicted life expectancy in people with HIV is high in settings with access to multiple antiretroviral drugs,” comment the investigators. “Delays in diagnosis pose the greatest risk of excess mortality for people with HIV.”

It is now well established that modern antiretroviral therapy significantly improves the life expectancy of patients with HIV. However, investigators from the UK were concerned that studies attempting to quantify prognosis may have underestimated the benefits of treatment because they did not take into account improvements in HIV therapy and care.

They therefore developed their own prognostic model. It was based on 10,000 theoretical gay men whose HIV was diagnosed in 2010. They selected this group because factors other than HIV impact on the prognosis of the other main groups affected by HIV in the UK.

Rates of HIV testing currently observed in UK gay men were incorporated into the model. These show that HIV is generally detected early, with median CD4 cell count at the time of diagnosis being 410 cells/mm3. It assumed that the patients had fully drug-sensitive HIV, had a 40% chance of being a smoker for life, were not co-infected with hepatitis and were never lost to follow-up. HIV treatment was started when the patients’ CD4 cell count fell to 350 cells/mm3 and the patients were fully adherent to this.

Higher rates of some non-HIV-related illnesses have been observed in patients with HIV. Therefore, the investigators assumed that their simulated patients were 50% more likely to die of such diseases than individuals in the general population.

The same scenario was considered for patients whose HIV was diagnosed late.

In ideal conditions, with timely diagnosis of HIV, the life expectancy of patients was 75 years (range, 63 to 83 years). This increased to 78 years if the patient did not smoke (range, 66 to 86 years).

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

PrEP Highly Accepted in the UK

via aidsmap, by Roger Pebody

"Just over half (52%) said they would consider it, while 30% weren’t sure and 17% wouldn’t consider taking PrEP."

While few gay men in England are currently aware of pre-exposure prophylaxis (PrEP), most men who are introduced to the idea support PrEP being made available. Half would consider taking it themselves, but most would prefer to take it on a daily basis, rather than before and after each time they have sex. These findings come from a snapshot survey of gay men in England, published by Sigma Research this week.

Pre-exposure prophylaxis (PrEP) involves HIV-negative people taking anti-HIV drugs in order to reduce their risk of infection. Results of the iPrEX study into the safety and effectiveness of PrEP in gay and other men who have sex with men showed that, overall, it reduced infections by 43%. Much higher levels of efficacy were seen in men with good adherence to PrEP.

Recent studies with American gay men have shown that while only a minority of men is aware of PrEP, a majority would consider using it. Most men say PrEP would not affect their own use of condoms, particularly if it is only partially effective.

To investigate the views of gay men in England, researchers put a series of questions to members of the Sigma Panel in June 2011. The panel is made up of approximately 1500 gay men, bisexual men and other men that have sex with men (MSM) who respond to monthly cross-sectional online surveys about HIV and sexual health. The surveys have a short turnaround for analysis and reporting to health workers.
Only men who do not have diagnosed HIV were asked about PrEP; 1259 responded.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

House of Lords Committee on HIV & AIDS calls for prevention prioritization

As encouraging results from recent PrEP and microbicide studies revolutionize the HIV/AIDS prevention landscape, the House of Lords Select Committee on HIV & AIDS in the UK has called for greater emphasis and funding toward prevention. The UK government spends up to £750 million each year on treatment, but less that £3 million on prevention campaigns. The committee reports that current efforts to fight the epidemic are “woefully inadequate” and that this failure can have “potentially huge cost implications”.

“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 … Prevention must be the key policy,” says Lord Fowler, chairman of the committee. (Incidentally, Lord Fowler was Health Secretary back in 1986, when he led the Don’t Die of Ignorance campaign on AIDS.)

The committee recommends a new national HIV campaign; failing that, it advises the prioritization of prevention messaging – especially testing. Additionally, it also highlights the need for greater funding for prevention efforts targeting gay men and Africans.

In a significant move for those working on new prevention technologies, the committee recommends that research into the use of PrEP to prevent infection in HIV-negative people needs to be a funding priority for the National Institute for Health Research and the Medical Research Council.

To read aidsmap’s detailed story on this development, click here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]