Last Updated: May 22, 2018; Last Reviewed: May 22, 2018
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Note: Bictegravir is only available in a fixed-dose combination tablet.
Fixed-Dose Combination Tablet:
- [Biktarvy] Bictegravir 50 mg plus emtricitabine 200 mg plus tenofovir alafenamide (TAF) 25 mg
||Selected Adverse Events
|[Biktarvy] Bictegravir plus Emtricitabine plus TAF
Pediatric/Adolescent Dose (Aged <18 Years):
Adult Dose (Aged ≥18 Years):
- Biktarvy has not been Food and Drug Administration-approved for use in patients aged <18 years.
- Children Aged <12 Years: No data on appropriate dose of Biktarvy in children aged <12 years.
- Children and Adolescents (Aged ≥12–18 Years and Weighing ≥35 kg): 1 tablet once daily. This is an investigational dose.
- 1 tablet once daily in ART-naive patients. This Biktarvy dose can also be used to replace the current ARV regimen in patients who have been virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
TAF-Associated Adverse Events:
- Diarrhea, nausea, headache
- Increases in low-density lipoprotein cholesterol and total cholesterol levels
- Administer with or without food.
- Screen patients for hepatitis B virus (HBV) infection before use of emtricitabine or TAF. Severe acute exacerbation of HBV can occur when emtricitabine or TAF is discontinued; therefore, monitor hepatic function for several months after halting therapy with emtricitabine or TAF.
- Biktarvy is not recommended for use with other ARV drugs.
- See the emtricitabine and TAF sections of the Drug Appendix for special instructions and additional information about the individual drug components of Biktarvy.
Biktarvy Dosing in Patients with Hepatic Impairment:
- Bictegravir is metabolized by cytochrome P (CYP) 450 3A and uridine diphosphate glucuronosyltransferase (UGT) 1A1.
- Refer to the emtricitabine and TAF sections of the Drug Appendix for more information on these components of Biktarvy.
Biktarvy Dosing in Patients with Renal Impairment:
- Biktarvy is not recommended for use in patients with estimated creatinine clearance <30 mL/min.
- Biktarvy is not recommended for use in patients with severe hepatic impairment.