Last Updated: September 12, 2019; Last Reviewed: September 12, 2019
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 (FDC).
Fixed-Dose Combination Tablet:
When using FDC tablets, refer to other sections of the Drug Appendix for special instructions, drug interaction information, and additional information about the individual components of the FDC. See also Appendix A, Table 2. Antiretroviral Fixed-Dose Combination Tablets: Minimum Body Weights and Considerations for Use in Children and Adolescents.
- [Biktarvy] Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide (TAF) 25 mg
||Selected Adverse Events
Child (Weighing <25 kg) Dose:
Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
- There are currently no data available on the appropriate dose of Biktarvy in children aged <6 years and weighing <25 kg. Studies are currently being conducted to identify the appropriate dose for this age and weight group.
- One tablet once daily with or without food in antiretroviral (ARV) therapy-naive patients. This dose of Biktarvy can also be used to replace the current ARV regimen in patients who have been virologically suppressed (HIV RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
- Diarrhea, nausea, headache
- See the emtricitabine and TAF sections of the Drug Appendix for information about the adverse events that are associated with the use of these drugs.
- Administer Biktarvy with or without food. See “Drug Interactions” for guidance if administering with antacids or iron or calcium supplements.
- Screen patients for hepatitis B virus (HBV) infection before using emtricitabine or TAF. Severe acute exacerbation of HBV can occur when discontinuing emtricitabine or TAF; therefore, monitor hepatic function for several months after halting therapy with emtricitabine or TAF.
- Biktarvy is not recommended for use with other ARV drugs.
Biktarvy Dosing in Patients with Hepatic Impairment:
- Bictegravir is metabolized by cytochrome P450 3A4 and uridine diphosphate glucuronosyltransferase 1A1.
- Refer to the emtricitabine and TAF sections of the Drug Appendix for more information about the metabolism and elimination of these components of Biktarvy.
Biktarvy Dosing in Patients with Renal Impairment:
- Biktarvy is not recommended for use in patients with severe hepatic impairment.
- Biktarvy is not recommended for use in patients with estimated creatinine clearance <30 mL/min.