The Conference on Retroviruses and Opportunistic Infections has recently taken place. At that event the UK PROUD (PRe-exposure Option for reducing HIV in the UK: immediate or Deferred) study of pre-exposure prophylaxis (PrEP) for MSM reported its results, prior to publication in the coming months. The headline figure is an astonishing 86% for the reduction of risk of infection in the intervention group. Hitherto, results of PrEP trials, largely conducted in Africa, have often been disappointing. This is probably on account of poor adherence (VOICE D( STI/blog); Haberer & Bangsberg (STI/blog); Hendrix & Bumpus (STI/blog)). The good result achieved here is no doubt attributable to good adherence. It demonstrates, as these earlier trials have not, the true effectiveness of PrEP.
The UK trial included 545 participants at 13 practices. 276 were randomized to receive PrEP immediately, while the remaining 269 received it after a year. Earlier PrEP trials have been blind and placebo-controlled. But this design had the advantage of demonstrating the effectiveness of PrEP in real life. The participants were aware if they were taking the active drug and could have changed their sexual behaviour accordingly. Given one of the major concerns around PrEP is that of risk compensation – i.e. taking advantage of the protection of PrEP to engage in more risky behaviour than they would otherwise (Marcus & Grant (STI/blog); Baeten & Celum (STI/blog)) – this was a valuable aspect of the trial.
In the period to October 2014, there were 22 HIV infections – 3 in the immediate, and 19 in the deferred group. This gives us the headline figure of 86%. At this point, ethical considerations dictated that the study design be changed so all participants received PrEP from then on. Initially, this study was intended to be a pilot, and to be followed by a larger scale trial. The decisiveness of the interim findings, however, led to cancellation of that further study. (For an interesting commentary on the need for researchers to keep pace with changing ethical parameters, see Cohen & Sugarman (STI/blog)). Cost-effectiveness analyses are apparently underway. No details are given in the report. But evidently the high effectiveness observed in the study will allow investigators to present a far more positive case for PrEP than has been warranted by earlier trials (see Borquez & Hallett (STI); Gomez & Hallett (STI/blog); Cremin & Garnett (STI)). They are also working with stakeholders on how PrEP services could be commissioned across NHS and local authorities.