Biktarvy FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 8, 2021.
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 history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
- 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
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