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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Non-Nucleoside Reverse Transcriptase Inhibitors

Doravirine (Pifeltro, DOR)

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

Excerpt from Table 8

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

Excerpt from Table 8
Generic Name
(Abbreviation)
Trade Name
Formulation Dosing Recommendationsa Use in Pregnancy
Doravirine
(DOR)
Pifeltro

(DOR/3TC/TDF)
Delstrigo
DOR (Pifeltro):
  • 100 mg tablet
DOR/3TC/TDF (Delstrigo):
  • DOR 100 mg/3TC 300 mg/TDF 300 mg tablet
Standard Adult Doses
DOR (Pifeltro):
  • DOR 100 mg once daily with or without food
DOR/3TC/TDF (Delstrigo):
  • 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., 3TC, TDF)
No data are available on the placental transfer of DOR in humans, but animal studies suggest that DOR crosses the placenta.

Insufficient data to assess for teratogenicity in humans. No evidence of teratogenicity in rats or rabbits.
a Individual ARV drug doses may need to be adjusted in patients with renal or hepatic insufficiency (for details, see the Adult and Adolescent Antiretroviral Guidelines, Appendix B, Table 10).
             
Key: 3TC = lamivudine; ARV = antiretroviral; DOR = doravirine; FDC = fixed-dose combination; PK = pharmacokinetic; TDF = tenofovir disoproxil fumarate

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