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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

Carcinogenicity
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

Reproduction/Fertility
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 

Pharmacokinetics
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

References

  1. Elvitegravir [package insert]. Food and Drug Administration. 2014. Available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203093s000lbl.pdf. 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 http://www.APRegistry.com.

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