Biktarvy is a triple-combination anti-HIV-1 drug developed by Gilead Sciences, Inc., containing bictegravir, emtricitabine, and tenofovir alafenamide. As a complete antiviral treatment regimen, Biktarvy is indicated for adult patients with HIV-1 infection who have no history of antiretroviral therapy, or for virologically suppressed patients who need to switch from their current antiviral regimen.

How to Use Biktarvy

Routine Dosage Regimen

The standard dosage regimen for Biktarvy is one tablet taken orally once daily, which can be administered with or without food.

Each Biktarvy tablet contains 50 mg of bictegravir (equivalent to 52.5 mg of bictegravir sodium), 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide (equivalent to 28 mg of tenofovir alafenamide fumarate).

Necessary Tests Before Medication

Hepatitis B Virus (HBV) Infection Test: Emtricitabine and tenofovir alafenamide in Biktarvy also have activity against HBV, and discontinuation of the drug may lead to severe exacerbation of hepatitis B.

Renal Function Assessment: Including tests for serum creatinine, estimated creatinine clearance, urine glucose, and urine protein.

Additional Tests for Patients with Chronic Kidney Disease: Assessment of serum phosphorus levels is also required.

Dosage Adjustment of Biktarvy

Dosage Adjustment for Patients with Renal Impairment

Biktarvy is not recommended for patients with severe renal impairment (estimated creatinine clearance [CLcr] < 30 mL/min).

For patients with CLcr ≥ 30 mL/min, no dosage adjustment is needed.

Renal function indicators should be monitored regularly during treatment.

Dosage Adjustment for Patients with Hepatic Impairment

For patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment, no dosage adjustment of Biktarvy is required.

Biktarvy is not recommended for patients with severe hepatic impairment (Child-Pugh Class C), as studies have not been conducted in this population.

Precautions for Biktarvy Use in Special Populations

Use in Pregnant Women

Currently, there is limited human data on the use of Biktarvy during pregnancy.

Data from the Antiretroviral Pregnancy Registry (APR) show that the use of emtricitabine during pregnancy does not increase the risk of major birth defects.

Animal studies indicate that none of the components of Biktarvy showed adverse developmental effects at doses without maternal toxicity.

Pregnant women should consult a doctor before using Biktarvy and weigh the benefits and risks.

Use in Lactating Women

Breastfeeding by mothers infected with HIV-1 is not recommended to avoid the risk of postnatal transmission of HIV-1.

It is currently unknown whether Biktarvy or its components are excreted into human milk.

Animal data show that bictegravir and tenofovir can pass into breast milk.

Use in Children and Adolescents

The efficacy of Biktarvy in children and adolescents under 18 years of age has not been established, and its use is not recommended.

Use in Elderly Patients

The number of elderly patients aged 65 years and older in Biktarvy's clinical trials was insufficient to determine whether their response differs from that of younger patients.

Elderly patients should use Biktarvy with caution, with particular attention to changes in renal function.