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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

Dolutegravir (Tivicay, DTG)

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

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

Animal Studies 

Dolutegravir was not genotoxic or mutagenic in vitro. No carcinogenicity was detected in 2-year long-term studies in mice at exposures up to 14-fold higher than that achieved with human systemic exposure at the recommended dose, or in rats at exposures up to 10-fold higher in males and 15-fold higher in females than human exposure at the recommended dose.  

Dolutegravir did not affect fertility in male and female rats and rabbits at exposures approximately 27-fold higher than human clinical exposure, based on area under the curve, at the recommended dose. 

Animal Teratogenicity/Developmental Toxicity
Studies in rats and rabbits have shown no evidence of developmental toxicity, teratogenicity or effect on reproductive function with dolutegravir. 

Placental and Breast Milk Passage
Studies in rats have demonstrated that dolutegravir crosses the placenta in animal studies and is excreted into breast milk in rats. 

Human Studies in Pregnancy 

No studies of dolutegravir use in human pregnancy have been reported. No human data on placental passage or breast milk excretion are available.

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

  • 50 mg
  • DTG 50 mg plus ABC 600 mg plus 300-mg 3TC tablet
Standard Adult Dose
ARV-Naive or ARV-Experienced but Integrase Inhibitor-Naive Patients
DTG (Tivicay):
  • 1 tablet once daily, without regard to food.
DTG/ABC/3TC (Triumeq):
  • 1 tablet once daily, without regard to food.
ARV-Naive or ARV-Experienced but Integrase Inhibitor-Naive if Given with EFV, FPV/r, TPV/r, or Rifampin; or Integrase Inhibitor-Experienced
DTG (Tivicay):
  • 1 tablet twice daily, without regard to food.
PK in Pregnancy:
  • No PK data in human pregnancy.
Dosing in Pregnancy:
  • Insufficient data to make dosing recommendation.
Unknown placental transfer to fetus.

Insufficient data to assess for teratogenicity in humans. No evidence of teratogenicity in mice, 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: 3TC = lamivudine; ABC = abacavir; ARV = antiretroviral; DTG = dolutegravir EFV = efavirenz; FPV/r = fosamprenavir/ritonavir; PK = pharmacokinetic; TPV/r = tipranavir/ritonavir

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