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: May 22, 2018; Last Reviewed: May 22, 2018

Bictegravir (BIC)
Bictegravir (BIC)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations

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
Dosing Recommendations Selected Adverse Events
[Biktarvy] Bictegravir plus Emtricitabine plus TAF
Pediatric/Adolescent 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.
Adult Dose (Aged ≥18 Years):
  • 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.
  • Diarrhea, nausea, headache
TAF-Associated Adverse Events:
  • Increases in low-density lipoprotein cholesterol and total cholesterol levels
Special Instructions
  • 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.
Metabolism/Elimination
  • 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 Hepatic Impairment:
  • Biktarvy is not recommended for use in patients with estimated creatinine clearance <30 mL/min.
Biktarvy Dosing in Patients with Renal Impairment:
  • Biktarvy is not recommended for use in patients with severe hepatic impairment.

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