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 12, 2019; Last Reviewed: December 12, 2019

Excerpt from Table 10

Note: When using FDC tablets, refer to other sections in Appendix B and Table 10 for information about the dosing and safety of individual drug components of the FDC tablet during pregnancy.

Excerpt from Table 10
Generic Name
(Abbreviation)
Trade Name
Formulation Dosing Recommendationsa Use in Pregnancy
Dolutegravir
(DTG)
Tivicay

(DTG/3TC)
Dovato

(DTG/RPV)
Juluca

(DTG/ABC/3TC)
Triumeq
DTG (Tivicay):
  • DTG 50 mg tablet
DTG/3TC (Dovato):
  • DTG 50 mg/3TC 300 mg tablet
DTG/RPV (Juluca):
  • DTG 50 mg/RPV 25 mg tablet
DTG/ABC/3TC (Triumeq):
  • DTG 50 mg/ABC 600 mg/3TC 300 mg tablet
Standard Adult Doses
In ARV-Naive or ARV-Experienced (but INSTI-Naive) Patients
DTG (Tivicay):
  • One tablet once daily, without regard to food
DTG/3TC (Dovato):
  • One tablet once daily, without regard to food
DTG/RPV (Juluca):
  • One tablet once daily with food
DTG/ABC/3TC (Triumeq):
  • One tablet once daily, without regard to food
In ARV-Naive or ARV-Experienced (but INSTI-Naive) Patients Who Are Also Receiving EFV, FPV/r, TPV/r, or Rifampin
DTG (Tivicay):
  • One tablet twice daily, without regard to food
In INSTI-Experienced Patients
DTG (Tivicay):
  • One tablet twice daily, without regard to food
Pregnancy
PKs in Pregnancy:
  • AUC may be decreased during the third trimester compared with postpartum, but exposures during pregnancy are well above those needed to inhibit viral replication.
Dosing in Pregnancy:
  • No change in dose indicated.
  • For guidance about the 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 rats, or rabbits. In pregnancy surveillance data from Botswana, there was a slightly increased risk of NTDs in infants born to women who initiated DTG prior to pregnancy and who were receiving it at the time of conception.

DTG may be used as part of a Preferred regimen in all pregnant women at all gestational ages and as part of an Alternative regimen in women who are trying to conceive. Clinicians should discuss the risks and benefits of DTG use with the patient. For more information, see Updated 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 ingesting any preparation that contains 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 Antiretroviral Guidelines, Appendix B, Table 10).

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: 3TC = lamivudine; ABC = abacavir; ARV = antiretroviral; AUC = area under the curve; DTG = dolutegravir; EFV = efavirenz; FDC = fixed-dose combination; FPV/r = fosamprenavir/ritonavir; INSTI = integrase strand transfer inhibitor; NTD = neural tube defect; PK = pharmacokinetic; RPV = rilpivirine; TPV/r = tipranavir/ritonavir

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