FDA NewsPerspective

FDA approves Descovy for HIV PrEP, excluding cisgender women

The FDA has approved Descovy as a second option for HIV pre-exposure prophylaxis, or PrEP, in at-risk adults and adolescents. The approval excludes patients who have receptive vaginal intercourse due to a lack of efficacy data in this population, the agency said.

Results from the phase 3 Discover trial publicized earlier this year showed that Descovy (emtricitabine/tenofovir alafenamide, Gilead Sciences; FTC/TAF) was noninferior to Truvada (FTC/tenofovir disoproxil fumarate, Gilead Sciences; FTC/TDF) for HIV prevention in at-risk HIV-negative men and transgender women who have sex with men.

“This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the U.S. Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections,” Jeffrey Murray, MD, MPH, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.

FTC/TDF has been the only option for HIV PrEP since its approval in 2012. The FDA approved FTC/TAF to treat HIV in 2016.

Gilead said earlier this year that FTC/TDF would come off patent a year early in the U.S. and would be available as a generic starting on Sept. 30, 2020. FTC/TDF has been shown to be highly effective at preventing HIV infections, but there have been issues with uptake and cost, with the medication costing more than $20,000 per year, according to HHS.

HHS announced this year that Gilead agreed to donate free HIV PrEP for up to 200,000 people annually for up to 11 years in a program focusing on underserved, high-risk and low-income areas. It said FTC/TDF would be continuously donated until FTC/TAF became available. – by Gerard Gallagher

Disclosure: Murray reports no relevant financial disclosures.

The FDA has approved Descovy as a second option for HIV pre-exposure prophylaxis, or PrEP, in at-risk adults and adolescents. The approval excludes patients who have receptive vaginal intercourse due to a lack of efficacy data in this population, the agency said.

Results from the phase 3 Discover trial publicized earlier this year showed that Descovy (emtricitabine/tenofovir alafenamide, Gilead Sciences; FTC/TAF) was noninferior to Truvada (FTC/tenofovir disoproxil fumarate, Gilead Sciences; FTC/TDF) for HIV prevention in at-risk HIV-negative men and transgender women who have sex with men.

“This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the U.S. Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections,” Jeffrey Murray, MD, MPH, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.

FTC/TDF has been the only option for HIV PrEP since its approval in 2012. The FDA approved FTC/TAF to treat HIV in 2016.

Gilead said earlier this year that FTC/TDF would come off patent a year early in the U.S. and would be available as a generic starting on Sept. 30, 2020. FTC/TDF has been shown to be highly effective at preventing HIV infections, but there have been issues with uptake and cost, with the medication costing more than $20,000 per year, according to HHS.

HHS announced this year that Gilead agreed to donate free HIV PrEP for up to 200,000 people annually for up to 11 years in a program focusing on underserved, high-risk and low-income areas. It said FTC/TDF would be continuously donated until FTC/TAF became available. – by Gerard Gallagher

Disclosure: Murray reports no relevant financial disclosures.

    Perspective
    Jeanne M. Marrazzo

    Jeanne M. Marrazzo

    The FDA decision intensifies concern for the landscape of HIV prevention options in women for several reasons. First, omitting women from otherwise largely generalizable recommendations for a biomedical agent known to be safe and effective highlights the fact that women were not viewed as important enough to be included in the relevant study in the first place. Second, other PrEP agents in development — like cabotegravir — involve extended-release formulations and are not enrolling women not using contraception who wish to conceive, so generalizability of their findings will be limited to reproductive age women. Third, the dapivirine ring, which demonstrated moderate efficacy in two large randomized controlled trials, remains in regulatory limbo. Don’t women deserve their own strategic vision for HIV prevention? 

    • Jeanne M. Marrazzo, MD, MPH
    • Infectious Disease News Editorial Board member
      Director, division of infectious diseases
      C. Glenn Cobbs, MD, Endowed Professor in Infectious Diseases
      University of Alabama at Birmingham School of Medicine

    Disclosures: Marrazzo reports serving in the past year on an advisory board for prevention for Gilead Sciences and to being a data and safety monitoring board member for the company.