FDA Approves Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) for HIV-1 Infection

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FDA Published May 22, 2026 Medically reviewed May 22, 2026 DOI ↗ By Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

Key Takeaway

Consider Biktarvy as a complete once-daily regimen for HIV-1 in eligible adults and children weighing at least 14 kg, but avoid in severe renal or hepatic impairment.

The FDA has approved Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg. The approval covers two populations: those with no antiretroviral treatment history, and virologically suppressed patients (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to bictegravir or tenofovir. Biktarvy combines bictegravir, an integrase strand transfer inhibitor, with emtricitabine and tenofovir alafenamide, both nucleoside analog reverse transcriptase inhibitors. The approval provides a once-daily single-tablet regimen option for a broad range of patients, including children weighing as little as 14 kg. Clinicians should note that Biktarvy is not recommended in patients with severe renal impairment (eCrCl 15 to below 30 mL/min) or severe hepatic impairment (Child-Pugh Class C).

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

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).

Indication & Patient Population

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.

Dosing & Administration

Recommended dosage in adults and pediatric patients weighing at least 25 kg: One tablet containing 50 mg BIC, 200 mg FTC, and 25 mg TAF taken once daily with or without food. In pediatric patients weighing at least 14 kg to less than 25 kg: One tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes. Biktarvy is not recommended in patients with estimated creatinine clearance of 15 to below 30 mL/min, or below 15 mL/min who are not receiving chronic hemodialysis, or below 15 mL/min who have no antiretroviral treatment history. Biktarvy is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Prior to or when initiating Biktarvy, test for hepatitis B virus infection. Assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, also assess serum phosphorus. Biktarvy is not recommended in patients with severe renal impairment (eCrCl 15 to below 30 mL/min) or end stage renal disease (eCrCl below 15 mL/min who are not receiving chronic hemodialysis, or no antiretroviral treatment history and ESRD who are receiving chronic hemodialysis). Biktarvy is not recommended in patients with severe hepatic impairment (Child-Pugh Class C).

Place in Therapy

Biktarvy is a complete regimen for HIV-1 infection in treatment-naive adults and pediatric patients weighing at least 14 kg, and for virologically suppressed patients switching from a stable regimen without resistance to bictegravir or tenofovir. It offers a once-daily single-tablet regimen with a fixed-dose combination of an INSTI and two NRTIs.

Study Details

Study typeFda approval

PublishedFeb 2018

View Original Abstract ↓

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 )