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Genvoya FDA Approval History

Last updated by Judith Stewart, BPharm on March 8, 2021.

FDA Approved: Yes (First approved November 5, 2015)
Brand name: Genvoya
Generic name: cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide
Dosage form: Tablets
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection

Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide or E/C/F/TAF) is an antiretroviral combination for the treatment of HIV infection.

  • Genvoya contains a newer form of tenofovir (tenofovir alafenamide or TAF) which provides lower levels of tenofovir in the bloodstream, but higher levels within the cells where the HIV-1 virus replicates. The combination of antiretroviral drugs in Genvoya has efficacy comparable to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate or E/C/F/TDF), but appears to be associated with less kidney toxicity and decreases in bone density than the tenofovir disoproxil fumarate (TDF) combination.
  • Genvoya is a fixed-dose combination of four antiretroviral drugs: elvitegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), cobicistat, a CYP3A inhibitor, and emtricitabine and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs). It is indicated as a complete regimen for the treatment of HIV-1 infection in patients with body weight at least 25 kg.
  • Genvoya tablets are taken orally once daily with food.
  • Common side effects include nausea, diarrhea, headache, and fatigue.

Development Timeline for Genvoya

DateArticle
Nov  5, 2015Approval  FDA Approves Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) for HIV
Oct 22, 2015Gilead Announces Phase 3 Results for Genvoya (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), an Investigational Once-Daily Single Tablet Regimen for HIV

Further information

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