The Food and Drug Administration (FDA) has approved Descovy (emtricitabine and tenofovir alafenamide; Gilead) for HIV-1 pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents (≥35kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at-risk from receptive vaginal sex (effectiveness in this population has not been evaluated).
The approval was based on data from the phase 3 DISCOVER trial that found Descovy to be noninferior to Truvada (emtricitabine and tenofovir disoproxil fumarate; Gilead) for PrEP in reducing the risk of HIV-1 infection in at-risk men and transgender women. In addition, the study showed statistically significant improvements in renal and bone laboratory parameters in patients receiving Descovy compared with those on Truvada.
“This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the US Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections,” said Jeffrey Murray, MD, MPH, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.
Approval of the PrEP indication adds a new Boxed Warning to the prescribing information regarding the risk of drug resistance with the use of Descovy for PrEP in undiagnosed early HIV-1 infection as drug-resistant HIV-1 variants have been identified with the use of Truvada for PrEP following undetected acute HIV-1 infection. Prior to initiating Descovy for PrEP, HIV-1-negative status must be confirmed.
“Descovy for PrEP provides a new HIV prevention option that matches Truvada’s high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences.
Each Descovy tablet contains 200mg of emtricitabine and 25mg of tenofovir alafenamide, both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs).
For more information visit fda.gov.