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Gilead's Truvada wins US FDA approval to reduce HIV-1 risk in adolescents

The U.S. Food and Drug Administration approved Gilead Sciences Inc.'s Truvada to reduce the risk of sexually acquired HIV-1 in adolescents.

Once-daily oral Truvada was approved, in combination with safer sex practices, for the indication. Truvada for the prevention of HIV in uninfected adults, a strategy called pre-exposure prophylaxis, was first approved for use in adults in 2012.

In the U.S., adolescents and young adults 13 to 24 years of age composed 21% of all new infections in 2016, and 81% of those infections were among young men who have sex with men, according to the U.S. Centers for Disease Control and Prevention.

The expanded indication is based on a study, named ATN113, where 67 HIV-1 negative young men who have sex with men in between the age of 15 years to 17 years received Truvada once daily for pre-exposure prophylaxis. The Truvada safety profile in the study was similar to the safety profile that has been observed in adult trials of the drug.