The FDA approved Truvada™ (emtricitabine/tenofovir disoproxil fumarate) for use once daily as pre-exposure prophylaxis (PrEP) to reduce the risk of human immunodeficiency virus (HIV) infection. The approved use is in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk. Truvada is manufactured by Gilead Sciences and public health advocates noted that the approval could help slow the spread of HIV, which has averaged about 50,000 new infections per year for the last 15 years.
According to the agency, support for approval of Truvada for a PrEP indication was derived mainly from (1) a three year iPrEx clinical trial, sponsored by the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAIDS), which studied Truvada for PrEP in men who have sex with men (MSM) and transgender women who have sex with men, and (2) a Partners PrEP trial, sponsored by the University of Washington, which studied Truvada for PrEP in heterosexual couples where one partner is HIV-infected and the other is not. The FDA also reviewed safety data from a Centers for Disease Control and Prevention 4323 trial conducted in 400 U.S. MSM, as well as top-line summaries and available abstracts from other completed or ongoing clinical trials.
The iPrEx trial resulted in a 42 percent reduction of HIV infection compared to placebo when used in combination with other preventive measures. In the PrEP trial, Truvada was observed to reduce the risk of HIV infection by 75 percent compared to placebo.
Truvada is the first drug approved 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. In 2004, the FDA had approved Truvada to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults. Subsequent approval expansion was made in 2011 for treatment of children 12 years or older.