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Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States

Integrase Inhibitors

Elvitegravir (Stribild, EVG/COBI/TDF/FTC)

(Last updated: August 6, 2015; last reviewed: August 6, 2015)

Elvitegravir is classified as Food and Drug Administration Pregnancy Category B.

Animal Studies

Elvitegravir was not genotoxic or mutagenic in vitro. No carcinogenicity was detected in long-term studies in mice at exposures up to 14-fold and rats at exposures up to 27-fold that achieved with human systemic exposure at the recommended dose.1

Elvitegravir did not affect fertility in male and female rats at approximately 16- and 30-fold higher exposures than in humans at standard dosing. Fertility was normal in offspring.1

Teratogenicity/Developmental Toxicity
Studies in rats and rabbits have shown no evidence of teratogenicity or effect on reproductive function with elvitegravir.1

Placental and Breast Milk Passage
No data on placental passage are available for elvitegravir.  Studies in rats have demonstrated that elvitegravir is secreted in breast milk. 

Human Studies in Pregnancy 

No pharmacokinetic studies of elvitegravir in human pregnancy have been reported.

Placental and Breast Milk Passage
No data are available on placental or breast milk passage of elvitegravir in humans.

Teratogenicity/Developmental Toxicity
In the Antiretroviral Pregnancy Registry, insufficient numbers of first-trimester exposures to elvitegravir in humans have been monitored to be able to make a risk determination.2

Excerpt from Table 7a
Generic Name
Trade Name
Formulation  Dosing Recommendations Use in Pregnancy

Elvitegravir/ Cobicistat/ Emtricitabine/ Tenofovir Disoproxil Fumarate
Tablet (Vitekta):
  • 85 mg
  • 150 mg
Tablet (Stribild):
  • EVG 150 mg plus COBI 150 mg plus FTC 200 mg plus TDF 300 mg
 Standard Adult Dose (Vitekta)
  • EVG (as Vitekta) must be used in combination with an HIV PI co-administered with RTV and another ARV drug.
Recommended Elvitegravir Dosage Taken Once Daily with Food (All Drugs Administered Orally)
Dosage of Elvitegravir Dosage of Concomitant PI Dosage of Concomitant RTV
85 mg once daily Atazanavir 300 mg once daily 100 mg once daily
Lopinavir 400 mg twice daily 100 mg twice daily
150 mg once daily Darunavir 600 mg twice daily 100 mg twice daily
Fosamprenavir 700 mg twice daily 100 mg twice daily
Tipranavir 500 mg twice daily 200 mg twice daily

Standard Adult Dose (Stribild):
  • One tablet once daily with food.
PK in Pregnancy:
  • No PK studies in human pregnancy.
Dosing in Pregnancy
  • Insufficient data to make dosing recommendation.
No data on placental transfer of EVG/COBI are available.

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

a Individual antiretroviral drug dosages may need to be adjusted in renal or hepatic insufficiency (for details, see Adult Guidelines, Appendix B, Table 7).

Key to Abbreviations: ARV = antiretroviral; COBI = cobicistat; EVG = elvitegravir; FTC = emtricitabine; PI = protease inhibitor; PK = pharmacokinetic; RTV = ritonavir; TDF = tenofovir disoproxil fumarate


  1. Elvitegravir [package insert]. Food and Drug Administration. 2014. Available at Accessed May 11, 2015.
  2. Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry international interim report for 1 Jan 1989 - 31 July 2014. Wilmington, NC: Registry Coordinating Center. 2014. Available at

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