A PrEP study covering France and French speaking Canada has fast tracked its study programme after promising early results.
Only two weeks after the UK based PROUD Study decided to offer access to PrEP to all participants on the deferred arm of the study a joint French / French Canadian study, IPERGAY, has taken taken a similar decision.
The IPERGAY Study, which started back in 2012, was initially met with controversy when it was revealed that some people would be offered a placebo instead of Truvada – the co-formulated pill used that is used as the basis of PrEP.
Run by French national AIDS research institute (ANRS) the trial includes approximately 400 participants – who were offered counselling, regular HIV testing, screening for other sexually transmitted infections, vaccinations for Hepatitis B, condoms and lube.
ANRS contacted the IPERGAY trial data safety monitoring board (DSMB) to request a review of the current, unblinded data, after the announcement by the PROUD Study two weeks prior. After reviewing the results, which revealed a “very significant reduction” in the risk of HIV infection amongst the group taking PrEP, the DSMB recommended that all participants should now be offered Truvada.
Neither The IPERGAY Study, nor the PROUD Study, have yet released any actual data – but some initial results are expected in early 2015. As with the PROUD trial IPERGAY will continue, with all participants taking Truvada, for at least another twelve months – in order to gather data on long term use and efficacy.
Professor Jean-François Delfraissy, Director of ANRS, commented, “This is a major breakthrough in the fight against HIV. The results of the ANRS IPERGAY trial should change national and international recommendations for HIV prevention”.
Yusef Azad, Director of Policy and Campaigns at the National AIDS Trust, said: ‘This announcement from the ANRS IPERGAY trial is another exciting piece of news in the growing and powerful evidence base on the effectiveness of PrEP. It is especially important if it suggests that PrEP might work well when taken only around the time of sex rather than daily – that could be good news for costs.
“We will now need to look at how such “intermittent PrEP” works in a “real life” setting rather than a placebo-controlled trial. This news adds to the urgency of the NHS deciding how to introduce PrEP effectively to reduce the current record numbers of gay and bisexual men, and others at high risk, being diagnosed with HIV in the UK.”