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

Elvitegravir (EVG)

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

Excerpt from Table 8

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

Excerpt from Table 8
Generic Name
(Abbreviation)
Trade Name		 Formulation Dosing Recommendationsa Use in Pregnancy
Elvitegravir
(EVG)

Note: As of October 2017, the single-drug formulation of EVG (Vitekta) is no longer available.

(EVG/c/FTC/TAF)
Genvoya

(EVG/c/FTC/TDF)
Stribild
 EVG/c/FTC/TAF (Genvoya):
  • EVG 150 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg tablet
EVG/c/FTC/TDF (Stribild):
  • EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg tablet

Standard Adult Dose
Genvoya and Stribild

  • One tablet once daily with food

Pregnancy
PKs in Pregnancy:

  • PK studies in women who received EVG/c demonstrated significant reduction in EVG plasma exposure during pregnancy.
Dosing in Pregnancy:
  • EVG plasma concentrations are reduced with use of standard adult doses during pregnancy; however, higher-than-standard doses of EVG have not been studied. Insufficient data are available to recommend a dose for use in pregnancy.

For guidance about use of combination products in pregnancy, please see the specific sections on other components (i.e., COBI, FTC, TAF).

 Evidence of high placental transfer of EVG and low transfer of COBI.b             

Insufficient data to assess for teratogenicity in humans. No evidence of teratogenicity in rats or rabbits.

EVG/c is not recommended for use in pregnancy. For women who become pregnant while taking EVG/c, consider switching to a more effective, recommended regimen. If a woman continues taking a regimen that contains EVG/c, doses should be administered with a meal and should not be administered within 2 hours of ingesting any preparation that contains minerals such as iron or calcium, including prenatal vitamins.
a Individual ARV drug dosses 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 to Acronyms: ARV= antiretroviral; COBI = cobicistat; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FDC= fixed-dose combination; FTC = emtricitabine PK = pharmacokinetic; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate

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