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 7, 2018; Last Reviewed: December 7, 2018

Excerpt from Table 10a

Note: When using FDCs, refer to other sections in Appendix B and Table 10 for information about the dosing and safety of individual drug components of the FDC during pregnancy.

Generic Name
(Abbreviation)
Trade Name
Formulation Dosing Recommendations Use in Pregnancy
Bictegravir/ Emtricitabine/ Tenofovir Alafenamide
(BIC/FTC/TAF)
Biktarvy

Note: BIC is not available as a single-entity formulation.
BIC/FTC/TAF (Biktarvy):
  • BIC 50 mg plus FTC 200 mg plus TAF 25 mg tablet
Standard Adult Dose:
  • 1 tablet once daily with or without food
Dosing in Pregnancy:
  • There is insufficient data to make a dosing recommendation.
PK in Pregnancy:
  • No PK studies have been reported in human pregnancy.
  • 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.

To maximize BIC absorption, doses should not be administered within 2 hours of ingestion of any preparation containing minerals such as iron or calcium, including prenatal vitamins.
a Individual ARV drug dosages may need to be adjusted in patients with renal or hepatic insufficiency (for details, see the Adult and Adolescent Guidelines, Appendix B, Table 8).

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

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