Gilead Sciences, Inc. announced that the FDA approved once-daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Truvada) in combination with safe 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 is well established. Truvada for pre-exposure prophylaxis (PrEP) was first approved for use in adults in 2012.

The addition of the adolescent indication is backed by a single-arm, open-label clinical trial, ATN113, conducted in HIV-negative individuals 15–17 years old by the Adolescent Medicine Trials Network for HIV/Aids.

“Study ATN113 has demonstrated that Truvada for PrEP is a well-tolerated prevention option for adolescents who are vulnerable to HIV,” lead study investigator, Sybil Hosek, PhD, clinical psychologist, Cook County Health and Hospital System’s Stroger Hospital, said in a statement. “In addition to traditional risk-reduction strategies, health care providers and community advocates are now equipped with another tool to help address the incidence of HIV in younger at-risk populations.”

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