FDA Advisory Committee�s recommendation on Descovy for pre-exposure prophylaxis

Gilead Sciences, Inc. announced that the Antimicrobial Drugs Advisory Committee (AMDAC) of the FDA recommended approval of Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) for the proposed indication of pre-exposure prophylaxis (PrEP) in men and transgender women (TGW) who have sex with men by a vote of 16 to 2.

Prevention methods and practices are essential tools in the fight against HIV. PrEP is a vital tool in the fight against HIV and should be an available HIV prevention strategy for all appropriate individuals at risk for HIV infection. In addition, PrEP is included in clinical guidelines as part of a comprehensive prevention strategy for individuals at risk for HIV. The AMDAC reviewed Descovy data from the DISCOVER global Phase III clinical study, which evaluated the safety and efficacy of Descovy compared with Truvada in men and transgender women who have sex with men and are at high-risk for sexually acquired HIV infection.

Results from the DISCOVER trial demonstrated that Descovy achieved non-inferiority to Truvada in study participants who were at substantial and sustained risk of HIV acquisition. Additionally, statistically significant improvements in renal and bone laboratory parameters were observed for participants receiving Descovy versus those receiving Truvada.

The AMDAC also evaluated pharmacokinetic data on Truvada and Descovy for HIV treatment and PrEP in support of the potential use of Descovy for PrEP in cis-gender women, a population that was not part of the DISCOVER study. The committee voted 10 to 8 that there were not adequate data regarding the efficacy of Descovy for PrEP in cis-women.