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

Rilpivirine (Edurant, RPV)

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
Rilpivirine
(RPV)
Edurant

(RPV/FTC/TDF)
Complera

(RPV/DTG)
Juluca

(RPV/FTC/TAF)
Odefsey 		RPV (Edurant)
 Tablets:
  • 25 mg
RPV/FTC/TDF (Complera):
  • RPV 25 mg/FTC 200 mg/TDF 300 mg tablet
RPV/DTG (Juluca):
  • RPV 25 mg/DTG 50 mg tablet
RPV/FTC/TAF (Odefsey):
  • RPV 25 mg/FTC 200 mg/TAF 25 mg tablet
 Standard Adult Doses
RPV (Edurant):
  • RPV 25 mg once daily with food
RPV/FTC/TDF (Complera):
  • One tablet once daily with food
RPV/DTG (Juluca):
  • One tablet once daily with food
RPV/FTC/TAF (Odefsey):
  • One tablet once daily with food

Pregnancy
PKs in Pregnancy:
  • RPV PKs are highly variable during pregnancy. RPV AUC and trough concentration are 20% to 50% lower in pregnancy than postpartum. While most pregnant women exceeded target exposure, those with detectable viral loads had lower RPV troughs.
Dosing in Pregnancy:
  • While RPV plasma concentration is reduced during pregnancy, higher-than-standard doses have not been studied, and there is not enough data available to recommend a dosing change during pregnancy. Pregnant women receiving standard dosing should have their viral loads monitored more frequently than women who are not receiving RPV.
For guidance about the use of combination products in pregnancy, please see the specific sections on other components (i.e., DTG, FTC, TAF, TDF). 		Moderate to high placental transfer to fetus.b

No evidence of human teratogenicity (can rule out 2-fold increase in overall birth defects).

Two-drug regimens (e.g., the RPV/DTG FDC) are not recommended for use in pregnancy.
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).

b Placental transfer categories are determined by mean or median cord blood/maternal delivery plasma drug ratio:
          High: >0.6
          Moderate: 0.3–0.6
          Low: <0.3

Key: ARV = antiretroviral; AUC = area under the curve; DTG = dolutegravir; FDC = fixed-dose combination; FTC = emtricitabine; PK = pharmacokinetic; RPV = rilpivirine; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate

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