A bleak future for PrEP in the UK

Limited community awareness, late and superficial institutional support, and cost-effectiveness issues paint a bleak future for Pre-Exposure Prophylaxis in the UK.

On the opening day of the TasP PrEP Evidence Summit organised by IAPAC, Lord Fowler expressed his bemusement at the US attitude towards clean syringe and needle exchange programmes that have proven to be very efficient for the prevention of HIV transmission amongst People Who Inject Drugs (PWID). On the third day of the summit, during a panel discussion entitled “PrEP implementation – Perpsectives from the [medical] field”, I had to express my own bemusement at the UK’s approach to Pre-Exposure Prophylaxis (PrEP) that had demonstrated clinical efficacy for the prevention of HIV acquisition amongst gay men (and other vulnerable groups such as PWID and serodiscordant couples).

Better late than never?

The publication of the results of the iPrEX study in November 2010 started a revolution in the HIV prevention field. It may not have changed what we do yet, but it has definitively changed how we think HIV prevention and how we can use antiretrovirals both for the treatment of HIV infected people but also for the prevention of HIV aquisition by HIV-uninfected people.

Whislt the potential of PrEP to prevent infection was (too?) quickly recognised by the US Centre for Disease Control, and Truvada (the combination of two drugs used in the iPrEx study) was (too?) quickly licensed for use in prevention as well as treatment, it has taken three long years for a small group of UK “leading HIV charities” to finally acknowledge the existence of PrEP as an HIV prevention option beside and beyond condoms.

As late as Sunday 22nd of September 2013, one of the main “leading HIV charities” was still in denial about PrEP and still recommended condoms, of diverse sizes, colours and shapes as options for HIV prevention, and tried to convince a well educated audience that condom promotion works with the support of a mathematical model. That model developped by Prof Andrew Phillips from UCL shows that if condoms had not been used the HIV epidemic in the UK would have been much worst. It is a great model showing what it aimed to show: the impact of condom use on HIV transmission. Not the impact of condom promotion on HIV prevention. The reality is that condom use has remained stable for the past 10 years, between 40% and 60% of sex acts. Condom promotion may have prevented condom use to fall, but this remains to be demonstrated, as does the claim to glory.

That it took so long to get PrEP formally recognised is a very good example of what WHO Reuben Granich described as cycling very slowly through the OODA Loop of Observe, Orient, Decide, Act. It is somewhat disheartening that even organisations that had shown much more courage and imagination in the past when it comes to HIV prevention messaging also got stuck in the OODA loop. As an aside, there is another promising HIV prevention called Rectal Microbicides and “leading HIV charities” may want to look what is done in that field now.

A statement that says more with what it does not say

After first recalling that “for a wide variety of reasons, many gay men do not use condoms all of the time” and that “Data from trials of PrEP suggest that it is very effective at preventing HIV, similar to condom use, as long as treatment is taken daily”, the logical next heading would have been “Where to get PrEP from?”

And this where the statement if found dearly wanting.

There is a very good reason for this heading to be missing: in the UK, PrEP is not available outside clinical studies, actually, one clinical study called PROUD.

Instead the statement raises the specter of PrEP encouraging risky behaviour and to address this refers to the PROUD clinical study, which is “recruiting gay men who may be at risk of getting HIV to find out what impact PrEP has on sexual behaviour and how well gay men are able to use it.”

But we already know from a number of past and ongoing studies that PrEP does not encourage risky behaviour and though this information comes from clinical studies and that it could be different in the real world this is not the purpose of the PROUD study.

Misunderstanding research?

In its current stage, the PROUD study is a feasibility study which will enrol up to 500 HIV negative men who have unprotected anal intercourse (UAI) with men, half of which would only be given PrEP after a year in the study. The primary objective of this pilot is to determine the feasibility of conducting a larger study that would determine whether the immediate inclusion of anti-retroviral pre-exposure prophylaxis (PrEP) as part of an HIV risk reduction package for men who have sex with men who are at risk of acquiring HIV is clinically effective and cost-effective in the UK.

The main objective of that large study is determining the cost-effectiveness of PrEP, because that is what it all boils down to: cost and money.

To date, the study has enrolled half of the participants it aimed to recruit, which means that PrEP in the UK is currently available to about 250 men. What will happen next? Will PrEP ever be available? When? These questions will be answered IF and AFTER a larger trial is conducted, which means that as things stand now PrEP in the UK is wishful thinking.

The question of why issuing a statement in support of PrEP now when it is not available and may never be is puzzling. What will happen once the PROUD pilot study is fully enrolled? What will these “leading HIV charities” tell their customers about PrEP? How will they handle PrEP and those asking for it? Back to offering condoms whilst we wait?

So what next?

For the record I am fully supportive of the PROUD study because it will tell us a lot about gay men and how they are using/will be using PrEP. The study may confirm what we already know about PrEP, that it works when it is taken, but not when it is not, but there will be several years before PrEP eventually becomes available. Much more evidence to support the value (read cost-effectiveness) of PrEP as part of an HIV risk reduction package will be needed to convince the commissioner of the usefulness of the approach.

Though I am not a great believer in PrEP as a public health intervention that would make a difference at population level, I believe that PrEP works and that it can make a difference at individual level. As such, PrEP should be made available to those who feel they need it and who are prepared to take it exactly as instructed for a limited period of time. And let’s be realistic, PrEP is not for everybody, it is a niche intervention and there is no queue for PrEP outside the GUM clinic in the UK or even in the US where it is available since 2012 and where prescriptions were more likely to go to Southern women than men.

So, if you read this and are interested in accessing PrEP, I strongly suggest you join the PROUD study ASAP! First because it will hasten the speed of research and second because once PROUD is fully enrolled, you will have more chance to get PrEP in Malawi than in the UK.


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