Gilead announces FDA approval of once-daily oral Truvada
Gilead Sciences announced that the FDA has approved once-daily oral Truvada-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, or 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 United States, adolescents and young adults 13 to 24 years of age comprised 21 percent of all new infections in 2016, according to the U.S. Centers for Disease Control and Prevention, and 81 percent of those infections were among young men who have sex with men, or YMSM. Truvada for PrEP is now indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg. Individuals must have a negative HIV test immediately prior to initiating Truvada for PrEP. Truvada has a boxed warning in its product label regarding the risks of post treatment acute exacerbation of hepatitis B and the risk of drug resistance with the use of Truvada for PrEP in undiagnosed early HIV infection. Further important safety information, adverse drug reactions and prescribing considerations are included below.