FDA label
What is Biktarvy used for?
Biktarvy contains bictegravir, 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: “BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg: with no antiretroviral treatment history, or; with an antiretroviral treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibit...”
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Biktarvy, tablet
Indications and Usage, quoted from the label by Gilead Sciences, Inc. (NDA210251). Cross-references to other label sections are left out.
BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg:
- with no antiretroviral treatment history, or
- with an antiretroviral treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir, 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 with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.
Source: DailyMed label, set id 664cb8f0-1f65-441b-b0d9-ba3d798be309, version 26, effective September 9, 2026. NDC 61958-2501, one of 4 listings for this product.
Questions
What is Biktarvy used for?
The FDA label says: “BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg: with no antiretroviral treatment history, or; with an antiretroviral treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibit...”
What drug class is Biktarvy?
FDA lists bictegravir, emtricitabine and tenofovir alafenamide in the Hepatitis B Virus Nucleoside Analog Reverse Transcriptase 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 Biktarvy
- Is Biktarvy a controlled substance?Federal schedule
- Generic for BiktarvyFDA Orange Book
- Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitors listFDA drug class
- Biktarvy Medicare Part D coverageBy plan and state
- NDC 50090-6247Biktarvy NDC record
- NDC 61958-2501Biktarvy NDC record
- NDC 61958-2505Biktarvy NDC record