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These highlights do not include all the information needed to use BIKTARVY safely and effectively. See full prescribing information for BIKTARVY. BIKTARVY® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2018
Medication labelWhy this: Advisory · dailymed-prescription
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 [see Dosage and Administration (2.4), and Use in Specific Populations (8.1)].
- generic_name
- bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
- product_names
- bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
- ndc
- 61958-2501, 61958-2501-1, 61958-2501-2, 61958-2501-3, 61958-2501-5, 61958-2505, 61958-2505-1, 61958-2506, 61958-2506-1
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en