Dosage of Biktarvy

1. Testing Before and During Biktarvy Treatment

Test patients for hepatitis B virus (HBV) infection before initiating or reinitiating Biktarvy.

Before initiating or reinitiating Biktarvy, and during Biktarvy treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients as clinically needed. For patients with chronic kidney disease, additionally assess serum phosphorus.

2. Recommended Dosage for Adults and Pediatric Patients Weighing At Least 25 kg

Biktarvy is a fixed-dose combination product containing bictegravir, emtricitabine, and tenofovir alafenamide. The recommended dosage of Biktarvy is one tablet (containing 50 mg bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide) taken orally once daily, with or without food. This dosage applies to:

Adults and pediatric patients weighing at least 25 kg with an estimated creatinine clearance of ≥ 30 mL/min;

Or virologically suppressed adult patients with an estimated creatinine clearance of < 15 mL/min who are receiving chronic hemodialysis. On hemodialysis days, the daily dose of Biktarvy should be administered after the completion of hemodialysis treatment.

3. Recommended Dosage for Pediatric Patients Weighing At Least 14 kg to Less Than 25 kg

The recommended dosage of Biktarvy is one tablet (containing 30 mg bictegravir, 120 mg emtricitabine, and 15 mg tenofovir alafenamide) taken orally once daily, with or without food. This dosage applies to:

Pediatric patients weighing at least 14 kg to less than 25 kg with an estimated creatinine clearance of ≥ 30 mL/min.

For children unable to swallow the entire tablet, the tablet may be split. All split parts must be administered within approximately 10 minutes, and the parts may be taken separately.

4. Recommended Dosage for Pregnant Patients

The recommended dosage of Biktarvy for pregnant patients is one tablet (containing 50 mg bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide) taken orally once daily, with or without food. This dosage applies to pregnant patients who:

Have achieved virologic suppression (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen;

Have no known substitutions associated with resistance to any individual component of Biktarvy.

Lower Biktarvy exposure has been observed during pregnancy; therefore, viral load should be closely monitored.

5. Not Recommended for Patients with Severe Renal Impairment

Biktarvy is not recommended for use in the following patients:

Patients with severe renal impairment (estimated creatinine clearance of 15 to < 30 mL/min);

Patients with end-stage renal disease (estimated creatinine clearance of < 15 mL/min and not receiving chronic hemodialysis);

Treatment-naive patients with end-stage renal disease who are receiving chronic hemodialysis.

6. Not Recommended for Patients with Severe Hepatic Impairment

Biktarvy is not recommended for use in patients with severe hepatic impairment.

FDA，2025.07