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Descovy Approval History

Reviewed by J.Stewart BPharm Last updated on Oct 3, 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 History and FDA Approval Process for Descovy

DateArticle
Oct  3, 2019Approval FDA Approves Descovy (emtricitabine and tenofovir alafenamide) for HIV Pre-Exposure Prophylaxis (PrEP)
Apr  4, 2016Approval FDA Approves Descovy (emtricitabine and tenofovir alafenamide), Gilead’s Third TAF-Based HIV Therapy
Sep  2, 2015Gilead’s Investigational Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide (F/TAF) Meets Primary 48-Week Objective in Phase 3 Study
Apr  7, 2015Gilead Submits NDA to FDA for Fixed-Dose Combination of Emtricitabine/Tenofovir Alafenamide for HIV

Further information

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