MAY 15, 2018

FDA Expands Indication for Truvada for PrEP Among Adolescents

By IDSE News Staff

The FDA granted a new indication for emtricitabine-tenofovir disoproxil fumarate (FTC/TDF; Truvada, Gilead Sciences) to reduce the risk for sexually acquired HIV-1 in at-risk adolescents

The safety and efficacy profile of FTC/TDF pre-exposure prophylaxis (PrEP) in adults is well established.

The addition of the adolescent indication is based on a study in HIV-negative adolescents aged 15 to 17 years. In the United States, 21% of all new infections in 2016 were among