FDA expands approval of Truvada for at-risk adolescents against HIV.- Gilead Sciences.

Gilead Sciences announced that the FDA has approved once-daily oral Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)—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 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 (YMSM).

The expanded indication is based on a single-arm, open-label clinical trial conducted by the Adolescent Medicine Trials Network for HIV/AIDS, a research network funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). In Study ATN113, 67 HIV-1 negative YMSM age 15 to 17 all received Truvada once daily for PrEP. The Truvada safety profile in the study was similar to the safety profile that has been observed in adult trials of Truvada for PrEP, in which the most common side effects were headache, abdominal pain and weight loss. Bone mineral density (BMD) was also monitored and four study participants had a decrease in BMD through 48 weeks (three adolescents had a modest decrease and one had a more than 4 percent decline in total BMD at Week 24).