FDA label
What is Genvoya used for?
Genvoya contains elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment...”
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Genvoya, tablet
Indications and Usage, quoted from the label by Gilead Sciences, Inc. (NDA207561). Cross-references to other label sections are left out.
GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of GENVOYA.
Source: DailyMed label, set id 34784acf-15ed-4715-b504-eb30430518e9, version 22, effective February 3, 2025. NDC 61958-1901, one of 1 listing for this product.
Questions
What is Genvoya used for?
The FDA label says: “GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment...”
What drug class is Genvoya?
FDA lists elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide in the Cytochrome P450 3A Inhibitor and Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Genvoya
- Is Genvoya a controlled substance?Federal schedule
- Generic for GenvoyaFDA Orange Book
- Cytochrome P450 3A Inhibitors listFDA drug class
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- Human Immunodeficiency Virus Integrase Strand Transfer Inhibitors listFDA drug class
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- Genvoya Medicare Part D coverageBy plan and state
- NDC 61958-1901Genvoya NDC record