The new prevention?

The Health Protection Agency (soon to become part of Public Health England) has proposed a radical shake-up in HIV prevention for gay men at the highest risk of acquiring HIV. The new idea was unveiled at the 17^th British HIV Association (BHIVA) conference last month.

Noel Gill, the HPA’s head epidemiologist, said, “it’s clear that we need to do something new” to reduce the stubbornly high HIV infection rate in gay men in the UK. Gill showed that, allowing for late reports, the number of men who have sex with men testing positive last year topped 3000 for the first time, representing an 11% increase on the previous year.¹

Heterosexual infections acquired in the UK have also doubled in the last decade but, at just over 1000 last year, are still one-third the rate amongst gay men. Since gay men probably form at most 5% of the adult population, this means a gay man has at least a 60 times greater risk of acquiring HIV in the UK than a heterosexual person.

Diagnoses in gay men had been static or even fallen slightly for the previous three years, creating tentative hopes we were starting to see the benefits of increased testing rates and an increasing proportion of HIV-positive people on treatment. Although the evidence is still not rock-solid, this seems to be happening in some other gay communities, such as in San Francisco.²

The new idea is to do a large pilot trial of a concept called Intensive Combination Prevention (ICP) in ten genitourinary medicine (GUM) clinics in England. In five of those, this would comprise six-monthly appointments including a full sexually transmitted infection (STI) screen, an HIV test, a behavioural questionnaire, and a standardised package of safer-sex advice, counselling and support. In the other five, pre-exposure prophylaxis (PrEP) would be added, via a daily tenofovir/FTC (Truvada) pill. This is the regimen used in the global iPrEx study, which found PrEP reduced HIV infections in gay men by 42%, and by more in those who took the pills consistently.³ Being prescribed PrEP would mean having to attend two more appointments a year to guard against undetected new HIV infections and to monitor any side-effects.

This package would only be offered to men at ‘high risk’ of HIV infection – those who either turned up with an acute STI or reported having unprotected sex with partners of HIV-positive or unknown status.

It is likely to be extremely hard to secure funding for this bold new prevention idea. Firstly, of course, the NHS is strapped for cash. In London, new prescribing guidelines recommend new HIV patients take the cheaper Kivexa (abacavir/3TC) instead of Truvada where possible. This would create the odd situation in which some HIV-negative gay men would be taking Truvada while their HIV-positive friends would not: but, as the only pill studied for PrEP, Truvada it has to be.

Secondly, some funding would have to come from local authorities, now responsible for public health, including running GUM/sexual health services. This could be presented as an opportunity – a way of providing a standardised and good-quality package of prevention for a local authority new to running clinics.

Thirdly, the idea probably won’t be viable if Truvada has to be bought at full cost: this means making the case to Gilead, a company facing an unexpected shortfall in UK-generated profits owing to the London procurement decision.

It may be deemed that the PrEP part, at least, is simply not cost-effective. The annual rate of new infections in repeat visitors (excluding those diagnosed on the first visit) to the 29 clinics involved in an existing collaboration with the HPA is 1.1% a year. That means you’d have to give 91 men PrEP for a year to prevent one new infection, at a cost of about £250,000, even if PrEP is 95% effective.

Lastly, a major spanner was thrown in the works at the end of April when the FemPrEP study was stopped because PrEP was making no difference to HIV infection amongst the women participating. This result is unexpected and may indicate that there is more we need to learn about whether antiretrovirals can prevent infections in different populations.

BHIVA, along with BASHH, the UK’s association of GUM physicians, is preparing a position statement on the use of PrEP. This is an independent project, but will form part of the guidance for the HPA project, should that prove to be feasible. BHIVA and BASHH are consulting a large number of community prevention experts and organisations in order to get views from all over the community.

With a trial of PrEP in gay men planned to start in France in September and other trial results expected soon, we are going through a period of unprecedented change in prevention policy. HIV has proven to be a lot harder to prevent than treat, and so far we have not found any ‘magic bullet’ that will stop the epidemic in its tracks. We need to make some very careful decisions about what to do next to make best use of the bullets we do have.

NAM is the community partner in the BHIVA/BASHH position statement project. To find out more email info@nam.org.uk.