FDA Approves Truvada for HIV Infection Prevention

Gilead Sciences announced that the FDA has approved Truvada (emtricitabine and tenofovir disoproxil fumarate tablets), for pre-exposure prophylaxis (PrEP) in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. This approval was based on data from two large placebo-controlled trials known as the Pre-Exposure Prophylaxis Initiative (iPrEx) and Partners PrEP that found that Truvada reduced the risk of acquiring HIV infection by 42% and 75%, respectively.

As part of the approval, Gilead worked with the FDA to develop a Risk Evaluation and Mitigation Strategy (REMS) to help ensure safe use of Truvada for PrEP as part of a comprehensive prevention strategy. Gilead has developed FDA-approved materials to educate and inform healthcare providers and uninfected individuals about Truvada for PrEP.