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 7, 2018; Last Reviewed: December 7, 2018

Excerpt from Table 10

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.

Excerpt from Table 10
Generic Name
(Abbreviation)
Trade Name		 Formulation Dosing Recommendationsa Use in Pregnancy
Elvitegravir
(EVG)

Note: As of October 2017, Vitekta (i.e., EVG as a single-entity formulation) is no longer available

(EVG/COBI/FTC/TAF)
Genvoya

(EVG/COBI/FTC/TDF)
Stribild
 EVG/COBI/FTC/TAF (Genvoya):
  • EVG 150 mg plus COBI 150 mg plus FTC 200 mg plus TAF 10 mg tablet
EVG/COBI/FTC/TDF (Stribild):
  • EVG 150 mg plus COBI 150 mg plus FTC 200 mg plus TDF 300 mg tablet
 Standard Adult Dose (Genvoya and Stribild):
  • 1 tablet once daily with food.
Dosing in Pregnancy:
  • Insufficient data to make dosing recommendation.
PK in Pregnancy:
  • PK studies in women who received EVG/c demonstrated significant reduction in EVG plasma exposure during pregnancy.
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/COBI is not recommended for initial use in pregnancy. For women who become pregnant while taking EVG/COBI, consider switching to a more effective, recommended regimen. If an EVG/COBI regimen is continued, 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).
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: COBI = cobicistat; EFV = efavirenz; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FDC= fixed-dose combination; FTC = emtricitabine PK = pharmacokinetic; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; TDM = therapeutic drug monitoring; WHO = World Health Organization

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