DESCOVY for PrEP: Post-marketing commitment (PMC)

DESCOVY for PrEP: Post-marketing commitment (PMC)

The U.S. Food and Drug Administration recently approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex. Descovy is not indicated in individuals at risk of HIV-1 infection from receptive vaginal sex because the effectiveness in this population has not been evaluated. Because no data were available at the time of approval for individuals at risk of HIV-1 infection from receptive vaginal sex, Gilead Sciences has a post marketing commitment (PMC) to conduct a randomized, comparative trial to evaluate the safety and efficacy of Descovy for PrEP in cisgender women and adolescent girls weighing at least 35 kg, who are at risk of sexually acquired HIV-1 infection. The PMC states the trial should include a Truvada arm and should employ two distinct methods to estimate the background HIV-1 incidence rate as external controls. HIV-1 incidence estimates should be based on current estimates from sites involved in recent clinical trials, cross-sectional HIV surveillance surveys, and from high quality local epidemiology data. Approval letter: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208215Orig1s012ltr.pdf Press Release: https://www.fda.gov/news-events/press-announcements/fda-approves-second-drug-prevent-hiv-infection-part-ongoing-efforts-end-hiv-epidemic

Kimberly Struble Division of Antiviral Products Food and Drug Administration Elizabeth Thompson Division of Antiviral Products Food and Drug Administration Michael Stanfield Jr. Division of Antiviral Products Food and Drug Administration