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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: October 26, 2016; last reviewed: October 26, 2016)

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
Pharmacokinetic (PK) studies of elvitegravir in human pregnancy are limited to a single case report of elvitegravir and cobicistat PK, safety, and efficacy in a single pregnant woman. Elvitegravir and cobicistat pharmacokinetics were assessed in this woman at 34 weeks’ gestation and repeated at 6 weeks postpartum. Elvitegravir area under the curve (AUC) was similar during pregnancy and postpartum, but Cmin was reduced by 60% during pregnancy compared to postpartum (and was below the suggested target concentration of 0.13 mg/L). Cobicistat AUC was reduced by 44% during pregnancy compared to postpartum. Despite the low elvitegravir Cmin, viral load remained undetectable throughout the pregnancy.2
 
Placental and Breast Milk Passage
The only data available on placental passage of elvitegravir in humans are from the single case report cited above. At delivery, maternal and cord blood plasma elvitegravir concentrations were both 0.30 mg/L.2 No data are available on human breast milk transfer of elvitegravir.

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.
 

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


Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate
(EVG/COBI/FTC/TDF)
Stribild


Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide
(EVG/COBI/FTC/TAF)
Genvoya
EVG Tablet (Vitekta):
  • 85 mg
  • 150 mg
Tablet (Stribild):
  • EVG 150 mg plus COBI 150 mg plus FTC 200 mg plus TDF 300 mg
Tablet (Genvoya):
  • EVG 150 mg plus COBI 150 mg plus FTC 200 mg plus TAF 10 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 ATV 300 mg once daily 100 mg once daily
LPV 400 mg twice daily 100 mg twice daily
150 mg once daily DRV 600 mg twice daily 100 mg twice daily
FPV 700 mg twice daily 100 mg twice daily
TPV 500 mg twice daily 200 mg twice daily

Standard Adult Dose (Stribild and Genvoya):
  • One tablet once daily with food.
PK in Pregnancy:
  • PK studies in human pregnancy limited to case report of 1 woman.
Dosing in Pregnancy
  • Insufficient data to make dosing recommendation.
Insufficient data are avilable on placental transfer of EVG/COBI.

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 the Adult and Adolescent Guidelines, Appendix B, Table 7).

Key to Abbreviations: ARV = antiretroviral; ATV = atazanavir; COBI = cobicistat; DRV = darunavir; EVG = elvitegravir; FPV = fosamprenavir; FTC = emtricitabine; LPV = lopinavir; PI = protease inhibitor; PK = pharmacokinetic; RTV = ritonavir; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; TPV = tipranavir

References

  1. Evitiegravir [package insert]. Food and Drug Administration. 2015. Available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203093s002lbl.pdf. Accessed July 15, 2016.
  2. Schalkwijk S, Colbers A, Konopnicki D, et al. First reported use of elvitegravir and cobicistat during pregnancy. AIDS. 2016;30(5):807-808. Available at http://www.ncbi.nlm.nih.gov/pubmed/26913711.
  3. Antiretroviral Pregnancy Registry Steering Committee. Antiretroviral Pregnancy Registry international interim report for 1 January 1989–31 July 2015. Wilmington, NC: Registry Coordinating Center. 2015. Available at http://www.apregistry.com/.
     

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