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 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
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 plus FTC 200 mg plus TDF 300 mg tablet
RPV/DTG (Juluca):
  • RPV 25 mg plus DTG 50 mg tablet
RPV/FTC/TAF (Odefsey):
  • RPV 25 mg plus FTC 200 mg plus TAF 25 mg tablet
Standard Adult Dose
RPV (Edurant):
  • RPV 25 mg once daily with food
RPV/FTC/TDF (Complera):
  • 1 tablet once daily with food
RPV/DTG (Juluca):
  • 1 tablet once daily with food
RPV/FTC/TAF (Odefsey):
  • 1 tablet once daily with food
PK in Pregnancy:
  • RPV PK highly variable during pregnancy. RPV AUC and trough concentration reduced 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. Insufficient data are available to recommend a dosing change in pregnancy. With standard dosing, viral loads should be monitored more frequently.
For guidance about 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., RPV/DTG FDC) are not recommended in pregnancy.
a Individual antiretroviral 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).
b Placental transfer categories—mean or median cord blood/maternal delivery plasma drug ratio:
          High: >0.6
          Moderate: 0.3–0.6
          Low: <0.3

Key to Acronyms: 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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