Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Integrase Inhibitors

Bictegravir

Last Updated: April 14, 2020; Last Reviewed: April 14, 2020

Bictegravir (BIC)
Bictegravir (BIC)
Formulations
Bictegravir is only available in a fixed-dose combination tablet (FDC).

Fixed-Dose Combination Tablet:
  • [Biktarvy] Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg
When using FDC tablets, refer to other sections of the Drug Appendix for 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. For additional information, see Drugs@FDA or DailyMed.
Dosing Recommendations Selected Adverse Events
[Biktarvy] Bictegravir/Emtricitabine/Tenofovir Alafenamide (TAF)
Child (Weighing <25 kg) 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.
Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • One tablet once daily with or without food in antiretroviral therapy-naive patients. This dose of Biktarvy can also be used to replace the current antiretroviral (ARV) regimen in patients who have been virologically suppressed (HIV RNA <50 copies/mL) on a stable ARV regimen for at least 3 months with no history of treatment failure and no known mutations associated with resistance to the individual components of Biktarvy.
  • Diarrhea, nausea, headache
Special Instructions
  • Administer Biktarvy with or without food. See Drug Interactions below for guidance when administering Biktarvy with antacids or iron or calcium supplements.
  • Screen patients for hepatitis B virus (HBV) infection before using emtricitabine (FTC) or TAF. Severe acute exacerbation of HBV can occur when discontinuing FTC or TAF; therefore, monitor hepatic function for several months after halting therapy with FTC or TAF.
  • Biktarvy is not recommended for use with other ARV drugs.
Metabolism/Elimination
  • Bictegravir is metabolized by cytochrome P450 3A4 and uridine diphosphate glucuronosyltransferase 1A1.
Biktarvy Dosing in Patients with Hepatic Impairment:
  • Biktarvy is not recommended for use in patients with severe hepatic impairment.
Biktarvy Dosing in Patients with Renal Impairment:
  • Biktarvy is not recommended for use in patients with estimated creatinine clearance <30 mL/min.

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