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

Dolutegravir (Tivicay, DTG)

Last Updated: December 7, 2018; Last Reviewed: December 7, 2018

Excerpt from Table 10a

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.

Generic Name
(Abbreviation)
Trade Name
Formulation Dosing Recommendations Use in Pregnancy
Dolutegravir
(DTG)
Tivicay

(DTG/RPV)
Juluca

(DTG/ABC/3TC)
Triumeq
DTG (Tivicay)
Tablet:
  • DTG 50 mg tablet
DTG/RPV (Juluca):
  • DTG 50 mg plus RPV 25 mg tablet
DTG/ABC/3TC (Triumeq):
  • DTG 50 mg plus ABC 600 mg plus 3TC 300 mg tablet
Standard Adult Dose
In ARV-Naive or ARV-Experienced (but Integrase Inhibitor-Naive) Patients
DTG (Tivicay):
  • 1 tablet once daily, without regard to food
DTG/RPV (Juluca):
  • 1 tablet once daily with 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:
  • AUC may be decreased during the third trimester compared with postpartum, but good viral suppression observed in third-trimester recipients.
Dosing in Pregnancy:
  • No change in dose indicated.
  • For guidance about use of combination products in pregnancy, please see the specific sections on other components (i.e., ABC, 3TC, RPV)
High placental transfer to fetus.b

No evidence of teratogenicity in mice, rats, or rabbits. Preliminary data suggest a possible increased risk of NTDs in infants born to women who initiated DTG prior to pregnancy and were receiving it at the time of conception.

Dolutegravir should not be initiated during the first trimester of pregnancy (less than 14 weeks [up to 13 6/7 weeks] gestational age by LMP.) For more information see Interim Guidance about the Use of Dolutegravir in Pregnancy in Recommendations for Use of Antiretroviral Drugs During Pregnancy.

To maximize DTG absorption, 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 doses 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 are determined by mean or median cord blood/maternal delivery plasma drug ratio:
          High: >0.6
          Moderate: 0.3–0.6
          Low: <0.3

Key to Acronyms: 3TC = lamivudine; ABC = abacavir; ARV = antiretroviral; AUC = area under the curve; DTG = dolutegravir; EFV = efavirenz; FDC = fixed-dose combination; FPV/r = fosamprenavir/ritonavir; LMP = last menstrual period; NTD = neural tube defect; PK = pharmacokinetic; RPV = rilpivirine; TPV/r = tipranavir/ritonavir

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