FDA Advisory Committee recommends Truvada (emtricitabine/tenofovir disoproxil fumarate) for HIV prophylaxis- Gilead Sciences

The FDA Antiviral Drugs Advisory Committee voted to recommend the use of Truvada (emtricitabine/tenofovir disoproxil fumarate) from Gilead Sciences, as a pre-exposure prophylaxis (PrEP) therapy to reduce the risk of HIV-1 infection among uninfected adults. The panellists voted 19-3 that the application supported a favourable risk-benefit assessment adequate to approve Truvada for PrEP in HIV-uninfected men who have sex with men (MSM).The committee voted 19-2, with one abstention, in supporting Truvada use for PrEP in the HIV-uninfected partners in serodiscordant couples and 12-8, with two abstentions, in declaring the data suported use for PrEP in individuals at risk for acquiring HIV through sexual activity. There currently is no pharmaceutical approved in the US as an HIV preventive.