As a three-in-one fixed-dose combination anti-HIV-1 medication, Biktarvy consists of bictegravir, emtricitabine, and tenofovir alafenamide. Developed by Gilead Sciences, it first received approval from the U.S. Food and Drug Administration (FDA) in 2018.

Indications for Biktarvy

Main Indications

Treatment-naive patients: Indicated as a complete treatment regimen for adult patients infected with HIV-1 who have no prior history of antiretroviral therapy.

Treatment-switching patients: For adult patients who have achieved virologic suppression and maintained stable treatment for ≥3 months, Biktarvy can replace the existing treatment regimen. However, this requires the patient to have no history of treatment failure and no known mutations conferring resistance to any component of Biktarvy.

Special Precautions

Risk of co-infection with hepatitis B virus (HBV): Screening for HBV is mandatory before initiating Biktarvy treatment. Discontinuation of Biktarvy may lead to acute exacerbation of hepatitis B, so continuous monitoring of liver function is required.

Contraindicated concurrent medications: Concurrent use with dofetilide or rifampin is prohibited. The former may cause life-threatening arrhythmias, while the latter significantly reduces the plasma concentration of bictegravir, leading to treatment failure.

Dosage Form and Properties of Biktarvy

Dosage Composition

Bictegravir 50 mg (equivalent to 52.5 mg of bictegravir sodium).

Emtricitabine 200 mg.

Tenofovir alafenamide 25 mg (equivalent to 28 mg of tenofovir alafenamide fumarate).

Physical Properties

Appearance: Purple-brown film-coated tablets, capsule-shaped, imprinted with "GSI" on one side and "9883" on the other side.

Administration method: One tablet taken once daily, either on an empty stomach or with food. However, co-administration with aluminum/magnesium-containing antacids should be avoided (an interval of at least 2 hours is required).

Storage Methods for Biktarvy

Routine Storage Conditions

Temperature: Maintain at 20-25°C (short-term fluctuations between 15-30°C are allowed).

Environment: Keep in a dry place, protect from direct sunlight, and store in the original packaging to seal out moisture.

Special Notes

Medication integrity: Tablets that are cracked or discolored should be discarded.

Child safety: Store out of the reach of children to prevent accidental ingestion.