An application from Gilead Sciences, Inc. has been filed with the U.S. Food and Drug Administration to approve an HIV antiretroviral therapy to reduce the risk of HIV infection among uninfected men who have sex with men (MSM) and heterosexual women and men. The application to approve the new HIV prevention method called pre-exposure prophylaxis, or PrEP, is based partly on data from the Global iPrEx study, the first human efficacy study to prove that PrEP reduces HIV infection risk in people (http://www.iprexnews.com).
The PrEP drug is a single-tablet once-daily combination of emtricitabine (FTC 200 mg) and tenofovir (TDF 300 mg), marketed under the brand name Truvada®. The iPrExstudy found that MSM who were prescribed a single daily FTC/TDF tablet experienced an average of 44% fewer HIV infections than those who received a placebo pill. Among a study sub-set those who took the tablet frequently enough for drug to be detected in their bodies, the rate of protection against HIV infection was more than 90%. All participants in the iPrEx study received condoms and comprehensive HIV prevention support. The HIV prevention benefits of PrEP were in addition to the benefits obtained from other prevention methods.
iPrEx study results were first reported in the New England Journal of Medicine in November, 2010 (http://www.nejm.org/doi/pdf/10.1056/NEJMoa1011205).
Data supporting the use of PrEP to reduce HIV infection risk in heterosexual men and women were provided by the Partners PrEP study, which involved 4758 HIV serodiscordant couples (couples in which one partner is HIV-infected and the other is not) at nine trial sites in Kenya and Uganda. Both the iPrEx and Partners PrEP studies found that PrEP is safe, with very low levels of side effects and limited risk of HIV drug resistance.
— From a press release
