In a surprising move, the World Health Organisation has come out in support of Pre-Exposure Prophylaxis (PrEP), recommending Men who have Sex with Men (MSM) to consider its use for HIV prevention alongside the use of condoms. It will be a huge challenge for countries where resources are limited and where delivering drugs for treatment is already a challenge, but what does it mean for countries like the United Kingdom with its world class National Health Services and an epidemic characterised by half of new HIV infections diagnosed amongst gay men and where PrEP, despite proven efficacy, remains unavailable?
The problem with PrEP is not that we don’t if it works – it does, with a 42% risk reduction when compared to a placebo in trial with MSM and potentially more than a 90% risk reduction when taken strictly as indicated. It is not that we don’t know if PrEP is cost-effective – mathematical modelling as shown that for each case of HIV infection averted an estimated £280,000 – £360,000 in lifetime cost-treatment could be saved. It is not that we don’t know if PrEP has side effects or an impact on sexual behaviour – several studies have provided data on safety (it is safe) and behaviour change (no changes noted so far in trial) and drugs used of PrEP have been used successfully and safely for treatment for many years.
The problem is that the health commissioners have to be convinced that it is worth spending money providing PrEP on the NHS (In 2013 the cost of daily Truvada was £418.50 per month, not including care). And convincing the commissioners seems to rest on the results of the PROUD Trial.
So what is the PROUD trial and when will its results be available?
The PROUD trial comprises a pilot study which involved recruiting 500 gay men and other men who have sex with men in the UK to assess the feasibility of conducting a larger clinical trial of PrEP in the UK. The PROUD feasibility which is the one currently much talked about has completed enrolment in March 2014. Its results will be known late in 2015.
In the meantime, funding is being sought for conducting the much larger PROUD trial which aim to enrol 2,300 participants and would dovetail with the feasibility study running from January 2015 to end of June 2018.
Whilst the PROUD feasibility study will provide some information about PrEP effectiveness and cost effectiveness these are not its primary measure of outcomes. What the PROUD feasibility study will be looking at is the time it took to recruit 500 participants and the retention of participants in the study at 12 and 24 months. These will inform the design and conduct of the larger PROUD trial. Other secondary outcomes will also be measured (e.g. safety, STI, adherence, behaviour changes) but only the large PROUD trial will be able to assess willingness of gay men at risk to take PrEP, adherence to daily pill regimen, impact on sexual behaviour and efficacy in a high risk group on a scale required to draw meaningful conclusions.
But results will not be available until 2019 at best and that is if the study gets funded.
PrEP for HIV has been evaluated and continue to be evaluated in more than 10 studies which will have involved more than 10,000 participants, providing a wealth of data and information. Can we wait 5 more years before deciding if gay men should be given access to PrEP in the UK? Soon it will already be 5 years since the results of the seminal iPrEX trial have been published and here we are, waiting for the results of an hypothetical trial conducted just for the UK.
Meanwhile, the world, and the UK is moving and not necessarily in the good direction. For the past 5 years a debate has been raging in the US (where PrEP is available since 2012) between those who support its use for HIV prevention (162 organisations signed a statement in support of PrEP) and those who opposed it, the Don-Quixotic AHF. The debate though initially welcomed and valuable has nevertheless become a parody, with PrEP opponents failing to move on with the tide of scientific data supporting the intervention (see the most recent iteration in the New York Times).
Unfortunately, this debate has not taken place in the UK where PrEP has been kept under the curtain until recently. And while we did not talk about it, people, potential users who could benefit from it, started to forge their mind about it without much knowledge of it, as illustrated by some of the comments to the WHO announcement when reported on Pink News. These are not exception.
There is a real risk that PrEP if ever available could suffer the same fate as Post Exposure Prophylaxis (limited public awareness, poor compliance). Have lessons been learned? Are lessons being ignored?
“Bold policies can deliver bold results”, said Dr Rachel Baggaley, from WHO’s HIV Department.
The WHO noted that “Failure to provide adequate HIV services for key groups – men who have sex with men, people in prison, people who inject drugs, sex workers and transgender people – threatens global progress on the HIV response, warns WHO.”
The Melbourne Declaration calls for making HIV pre-exposure prophylaxis available and to “establish demonstration projects that provide access to HIV pre-exposure prophylaxis to people at high risk of HIV infection” (Action Area 3).
In the US, the Public Health Service released the first comprehensive clinical practice guidelines for PrEP in May 2014 and the New York State Governor Andrew Cuomo has made PrEP a key part of his anti-HIV Strategy.
AIDES, the leading French HIV/AIDS organisation has called for immediate and effective access to PrEP based on the daily use of Truvada, a call supported by a group of French HIV Experts.
In the UK, we are PROUDLY waiting
And while we wait, the HIV epidemic remains unabated among gay men in the UK with more than 2,500 new diagnosed infections year on year since 2001 despite increased testing and increased uptake of treatment. Gay men are denied an opportunity that if provided in a controlled environment and through clever implementation programmes, would protect some of them from becoming infected with HIV.