bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate is listed in the FDA National Drug Code directory with 9 NDC codes, marketed under brand name including Biktarvy. Available dosage form: tablet.
Drug Details
- Generic Name
- bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate
- Brand Names
- Biktarvy
- Application Number
- NDA210251
- Sponsor
- Gilead Sciences, Inc.
- NDC Codes
- 9
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE
Indications and Usage
1 INDICATIONS AND USAGE 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: 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 with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. BIKTARVY is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 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 with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. ( 1 )