The Health Protection Agency (soon to become part of Public
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 17th 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
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
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.
is the community partner in the BHIVA/BASHH position statement project. To find
out more email email@example.com.