BRIEF—FDA expands Truvada indication

US biotech firm Gilead Sciences says that the US Food and Drug Administration has approved once-daily oral Truvada(emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) - in combination with safer sex practices - to reduce the risk of sexually acquired HIV-1 in at-risk adolescents.

The safety and efficacy profile of Truvada for HIV prevention in uninfected adults, a strategy called pre-exposure prophylaxis (PrEP), is well established, and Truvada for PrEP was first approved for use in adults in 2012.

The addition of the adolescent indication is based on a study in HIV-negative individuals 15 to 17 years of age. In the USA, adolescents and young adults 13 to 24 years of age comprised 21% of all new infections in 2016, according to the US Centers for Disease Control and Prevention, and 81% of those infections were among young men who have sex with men (YMSM).