U.S. Food and Drug Administration Approves Descovy® for HIV Pre-Exposure Prophylaxis (PrEP)
Descovy Demonstrated Non-inferior Efficacy and an Improved Bone and Renal Safety Profile Compared with Truvada® in People at Risk for Sexually Acquired HIV Infection in a Global Phase 3 Trial
Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) approved a pre-exposure prophylaxis (PrEP) indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF). Descovy for PrEP™ is indicated to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are HIV-negative and at-risk for sexually acquired HIV, excluding individuals at-risk from receptive vaginal sex.
“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. “This is a reflection of Gilead’s continued commitment to addressing the evolving needs of people living with or at risk for HIV and to driving innovation across the HIV care continuum.”
The FDA approved the supplemental New Drug Application (sNDA) for Descovy under a priority review designation. Descovy has a Boxed Warning in its U.S. product label regarding the risk of post treatment acute exacerbation of hepatitis B. The Descovy label also includes a Boxed Warning regarding the risk of drug resistance with PrEP use in undiagnosed early HIV-1 infection. The effectiveness of Descovy for PrEP in individuals at risk of HIV-1 from receptive vaginal sex has not been established; please see below for Important Safety Information.
The approval of a PrEP indication for Descovy, taken once daily with or without food in patients weighing at least 35 kg, is based on data from the DISCOVER trial, a multi-year global Phase 3 registrational clinical trial that evaluated the safety and efficacy of Descovy for PrEP compared with that of Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) for PrEP® in reducing the risk of acquiring HIV-1 infection. Enrollment included more than 5,300 adult cisgender men who have sex with men or transgender women (TGW) who have sex with men.
The primary efficacy endpoint of DISCOVER was the incidence of documented HIV infection per 100 person-years after all participants had follow-up of at least 48 weeks and at least half had 96 weeks of follow-up. These data, which were presented in March at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI), included 5,387 individuals who were randomized 1:1 to receive either Descovy or Truvada. Among the 2,694 participants (4,370 person-years (PY)) who were at risk of HIV-1 infection and received once-daily Descovy, seven HIV-1 infections (HIV-1 incidence 0.16/100 PY) were reported. Among the 2,693 participants (4,386 PY) who were at risk of HIV-1 infection and received Truvada, 15 HIV infections (0.34/100 PY) were reported.
Results from the DISCOVER trial demonstrated that Descovy achieved non-inferiority to Truvada in study participants who were at risk of HIV acquisition. Efficacy was strongly correlated to adherence to daily dosing.
Additionally, statistically significant advantages were observed with respect to all six pre-specified secondary endpoints for both renal and bone laboratory parameters in patients receiving Descovy compared to Truvada.
“Today, because of landmark biomedical and scientific research advances, there are unprecedented opportunities to significantly reduce new HIV infections,” said Edwin DeJesus, MD, FACP, FIDSA, Medical Director, Orlando Immunology Center. “Descovy for PrEP offers healthcare providers and appropriate people at risk for HIV an additional biomedical prevention option with a demonstrated improvement in bone and renal safety parameters as compared to Truvada.”
Descovy does not prevent other sexually transmitted infections or cure HIV infection or AIDS.
