Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States

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 (BIC)

Last Updated: December 24, 2019; Last Reviewed: December 24, 2019

Excerpt from Table 8

Note: When using FDCs, refer to other sections in Appendix B and Table 8 for information about the dosing and safety of individual drug components of the FDC during pregnancy.

Excerpt from Table 8
Generic Name
(Abbreviation)
Trade Name
Formulation Dosing Recommendationsa Use in Pregnancy
Bictegravir/ Emtricitabine/ Tenofovir Alafenamide
(BIC/FTC/TAF)
Biktarvy

Note: BIC is only available as part of an FDC tablet.             
BIC/FTC/TAF (Biktarvy):
  • BIC 50 mg/FTC 200 mg/TAF 25 mg tablet
Standard Adult Dose:
  • One tablet once daily with or without food

Pregnancy:
PKs in Pregnancy:
  • No PK studies in human pregnancy.
Dosing in Pregnancy:
  • Insufficient data to make dosing recommendations.

For guidance about use of combination products in pregnancy, please see the specific sections on other components (i.e., FTC, TAF).

No data are available on placental transfer of BIC.

Insufficient data to assess for teratogenicity in humans. No evidence of teratogenicity in rats or rabbits.

BIC can be taken with food at the same time as any preparation containing iron or calcium, including prenatal vitamins, but should not be administered within 2 hours of these preparations when taken on an empty stomach. BIC can be taken at least 2 hours before or 6 hours after antacids containing aluminum or magnesium.
a Individual ARV drug doses may need to be adjusted in patients with renal or hepatic insufficiency (for details, see the Adult and Adolescent Guidelines, Appendix B, Table 10).

Key to Acronyms: ARV = antiretroviral; BIC = bictegravir; FDC = fixed-dose combination; FTC = emtricitabine; PK = pharmacokinetic; TAF = tenofovir alafenamide

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