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Genvoya Approval History

  • FDA approved: Yes (First approved November 5th, 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 History and FDA Approval Process 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
Feb 26, 2015Gilead Announces Phase 3 Results for Investigational Once-Daily Single Tablet HIV Regimen Containing Tenofovir Alafenamide (TAF)
Sep 24, 2014Gilead’s Investigational Tenofovir Alafenamide (TAF)-Based Single Tablet HIV Regimen Meets 48-Week Primary Objective in Two Phase 3 Studies
Sep 13, 2013Gilead Releases Tenofovir Alafenamide Data from HIV Trial
Mar  5, 2013Gilead Announces Full 24-Week Phase 2 Results for Once-Daily Single Tablet HIV Regimen Containing Novel Prodrug Tenofovir Alafenamide (TAF)

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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