Emtricitabine, Tenofovir, Bictegravir Sodium

Overview

Bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate 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 that is FDA approved for the treatment of HIV-1 infection in adults 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 for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate. There is a Black Box Warning for this drug as shown here. Common adverse reactions include diarrhea, nausea, and headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indication

  • Bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults 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 for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate.

Dosage

  • Bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate is a three-drug fixed dose combination product containing 50 mg of bictegravir (BIC), 200 mg of emtricitabine (FTC), and 25 mg of tenofovir alafenamide (TAF). The recommended dosage of bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate is one tablet taken orally once daily with or without food.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding bictegravir sodium, emtricitabin tenofovir alafenamide fumarate Off-Label Guideline-Supported Use and Dosage (Adult) in the drug label.

Non–Guideline-Supported Use

There is limited information regarding bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate Off-Label Non-Guideline-Supported Use and Dosage (Adult) in the drug label.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness of bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate in pediatric patients less than 18 years of age have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate Off-Label Guideline-Supported Use and Dosage (Pediatric) in the drug label.

Non–Guideline-Supported Use

There is limited information regarding bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate Off-Label Non-Guideline-Supported Use and Dosage (Pediatric) in the drug label.

Contraindications

Bictegravir sodium/emtricitabine/tenofovir contraindications alafenamide fumarate is contraindicated to be co-administered with:

  • dofetilide due to the potential for increased dofetilide plasma concentrations and associated serious and/or life-threatening events.
  • rifampin due to decreased BIC plasma concentrations, which may result in the loss of therapeutic effect and development of resistance to bictegravir sodium/emtricitabine/tenofovir alafenamide fumarate.