Biktarvy FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 27, 2024.
FDA Approved: Yes (First approved February 7, 2018)
Brand name: Biktarvy
Generic name: bictegravir, emtricitabine and tenofovir alafenamide
Dosage form: Tablets
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection
Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) is a combination of an integrase strand transfer inhibitor (bictegravir) and two HIV-1 nucleoside analog reverse transcriptase inhibitors (emtricitabine and tenofovir alafenamide) used for the treatment of HIV-1 infection.
- Biktarvy 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. - The dual nucleoside reverse transcriptase inhibitor (NRTI) emtricitabine and tenofovir alafenamide combination was first approved under the brand name Descovy in 2016.
- Biktarvy tablets are taken orally once daily with or without food.
- Common adverse reactions include diarrhea, nausea, and headache.
Development timeline for Biktarvy
Further information
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