FDA announces approval of Gilead's Truvada for HIV prevention

The U.S. Food and Drug Administration said it approved Truvada to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk. The FDA previously approved Truvada to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older. As a condition of approval, Truvada’s manufacturer, Gilead Sciences, is required to collect viral isolates from individuals who acquire HIV while taking Truvada and to evaluate these isolates for the presence of resistance.