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

There are insufficient human data on the use of bictegravir in pregnancy to inform a drug-associated risk determination for birth defects and miscarriage.

Animal Studies

Carcinogenicity
Bictegravir was not genotoxic or mutagenic in vitro.1

Reproduction/Fertility
Bictegravir did not affect fertility, reproductive performance, or embryonic viability in male and female rats at exposures (area under the curve [AUC]) that were 29 times higher than those seen in humans receiving the recommended dose.1

Teratogenicity/Adverse Pregnancy Outcomes
No adverse embryo-fetal effects were observed in rats and rabbits at bictegravir exposures (AUC) of up to approximately 36 times (rats) and 0.6 times (rabbits) the exposures seen in humans receiving the recommended dose. Spontaneous abortion, increased clinical signs (e.g., fecal changes, thin body, and cold-to-touch), and decreased body weight were observed at a maternally toxic dose in rabbits (i.e., 1000 mg/kg/day; approximately 1.4 times higher than human exposure at the recommended dose).1

Placental and Breast Milk Passage
No data on placental passage are available for bictegravir. In a pre/postnatal development study conducted in rats, bictegravir was detected in the plasma of nursing rat pups on postnatal day 10, likely due to the presence of bictegravir in milk.1

Human Studies in Pregnancy

Pharmacokinetics
No pharmacokinetic studies of bictegravir have been reported in pregnant women.

Placental and Breast Milk Passage
No data are available on the placental or breast milk passage of bictegravir in humans.

Teratogenicity/Adverse Pregnancy Outcomes
No data are available to inform the risk determination for birth defects following bictegravir exposure.

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

References

  1. Bicitegravir/emtricitabine/tenofovir alafendamide fumarate (Biktarvy) [package insert]. Food and Drug Administration. 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210251s000lbl.pdf.

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