Truvada filed at FDA for reduction in HIV Risk

Gilead Sciences has submitted a supplemental new drug application to the FDA seeking approval of once-daily Truvada (emtricitabine/tenofovir disoproxil fumarate) as a pre-exposure prophylaxis (PrEP) therapy to reduce the risk of HIV-1 infection among uninfected adults. The application is based on the iPrEx trial where Truvada reduced HIV risk in men by 44% versus placebo and up to 73% for men taking the drug consistently. In the Partners PrEP trial, Truvada reduced HIV risk in hetrosexuals by 73% versus placebo.