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

Further information

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