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Genvoya FDA Approval History

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.

FDA Approval: The safety and efficacy profile for Genvoya was evaluated over four clinical trials. Genvoya was shown to be effective in reducing viral loads and comparable to the other HIV treatment regimens. Genvoya contains a newly approved 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.

Mechanism: 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 adults and pediatric patients 12 years of age and older.

Dosage: The recommended dosage is one tablet taken orally once daily with food.

Side Effects: The most common side effects associated with Genvoya are nausea, diarrhea, headache, and fatigue.

Additional Information: The product label for Genvoya comes with a Boxed Warning advising patients and healthcare professionals that the drug can cause a buildup of lactic acid in the blood (lactic acidosis) and severe liver problems (hepatomegaly and steatosis) which can be fatal. The Boxed Warning also states that Genvoya should not be used to treat chronic hepatitis B virus infection. Genvoya interacts with many commonly used medicines, and should not be taken with other antiretrovirals.

Development Timeline for Genvoya

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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