Therapy Areas: AIDS & HIV
US Food and Drug Administration Approves Descovy for HIV Pre-Exposure Prophylaxis
7 October 2019 - - The US Food and Drug Administration approved a pre-exposure prophylaxis indication for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF), US-based Gilead Sciences, Inc. (NASDAQ: GILD) said.

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.

The FDA approved the supplemental New Drug Application for Descovy under a priority review designation.

Descovy has a Boxed Warning in its US 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 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, included 5,387 individuals who were randomized 1: 1 to receive either Descovy or Truvada.

Among the 2,694 participants (4,370 person-years) 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.

Descovy does not prevent other sexually transmitted infections or cure HIV infection or AIDS.
Login
Username:

Password: