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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

DateArticle
Oct 18, 2021Approval  U.S. Food and Drug Administration Approves Expanded Indication of Gilead’s Biktarvy for Treatment of HIV-1 in Pediatric Populations
Feb  7, 2018Approval  FDA Approves Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for Treatment of HIV-1 Infection
Oct  4, 2017Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens
Aug 10, 2017Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV
Jun 12, 2017Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for HIV Treatment
May 30, 2017Gilead’s Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for the Treatment of HIV-1 Meets Primary Endpoint in Four Phase 3 Studies

Further information

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