Descovy FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 4, 2019.
FDA Approved: Yes (First approved April 4, 2016)
Brand name: Descovy
Generic name: emtricitabine and tenofovir alafenamide
Dosage form: Tablets
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection, Pre-Exposure Prophylaxis
Descovy (emtricitabine and tenofovir alafenamide) is a nucleoside analog HIV-1 reverse transcriptase inhibitor (NRTI) and nucleotide reverse transcriptase inhibitor (NtRTI) fixed-dose combination for the treatment of HIV-1 infection, and for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection.
HIV-1 Treatment
Descovy is indicated:
- in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg.
- in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor for the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg and less than 35 kg.
HIV-1 Pre-Exposure Prophylaxis (PrEP)
Descovy is indicated:
- in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. Individuals must have a negative HIV-1 test immediately prior to initiating Descovy for HIV-1 PrEP.
Development timeline for Descovy
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
