FDA Approves Truvada as PrEP for Adolescents

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On May 18, 2018, Gilead Sciences, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral Truvada for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in at-risk adolescents. Truvada has been used for HIV prevention in uninfected adults since 2012.

The approval for use by adolescents is based on a 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 the study, sixty-seven HIV-negative men ages fifteen to seventeen received Truvada once daily for PrEP. In the United States, young adults age thirteen to twenty-four accounted for twenty-one percent of new infections in 2016, according to the U.S. Centers for Disease Control and Prevention; eighty-one percent of those new infections were among young men who have sex with men (YMSM).

Truvada for PrEP, in combination with safer sex practices such as condom use, reduces the risk of sexually acquired HIV in at-risk adults and adolescents weighing at least 35 kg (approximately 77 pounds). Individuals must have a negative HIV test immediately prior to initiating Truvada for PrEP.

“We must make use of all available options when considering HIV prevention strategies, and we welcome the development that Truvada for PrEP is now available for younger people who are at risk of HIV,” said Matthew Rose, Policy and Advocacy Manager at NMAC, a Washington, D.C.-based advocacy organization. “We will continue to build awareness and understanding of the role of Truvada for PrEP as part of a comprehensive HIV prevention plan for all who may benefit from it, particularly among communities disproportionately impacted by the disease, including young Black and Latino men in the United States.”
—Reporting by Hank Trout


Hank Trout, Editor at Large, edited Drummer, Malebox, and Folsom magazines in the early 1980s. A long-term survivor of HIV/AIDS (diagnosed in 1989), he is a thirty-eight-year resident of San Francisco, where he lives with his fiancé Rick. Follow him on Twitter @HankTroutWriter.