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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General Principles Regarding Use of Antiretroviral Drugs during Pregnancy

Teratogenicity

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

Panel's Recommendations Regarding the Use of Antiretroviral Drugs during Pregnancy and Teratogenicity
Panel's Recommendations
  • All cases of antiretroviral (ARV) drug exposure during pregnancy should be reported to the Antiretroviral Pregnancy Registry (AIII).
  • Based on the preponderance of studies indicating no difference in rates of birth defects for first-trimester exposure compared with later ARV drug exposures, women can be counseled that ARV therapy during pregnancy generally does not increase the risk of birth defects (BIII), with the possible exception of dolutegravir.

Interim Panel Recommendations Regarding the Use of Dolutegravir at the Time of Conception and During Pregnancy:a

  • Dolutegravir is not recommended for use in nonpregnant women who are trying to conceive or during the first trimester of pregnancy,b,c due to concerns about a possible increased risk of neural tube defects (NTDs) (AIII).
  • Clinicians should discuss the possible increased risk of NTDs with women of childbearing potential who are currently receiving dolutegravir as part of their ART or who wish to be started on dolutegravir (AIII).
  • A pregnancy test should be performed prior to the initiation of dolutegravir (AIII).
  • Women who want to become pregnant or who cannot consistently use effective contraception should not initiate a dolutegravir-based regimen (AIII).
  • For pregnant women who are receiving dolutegravir and who present to care during the first trimester,b,c provide counseling about the risks and benefits of continuing dolutegravir or switching to another ARV regimen (AIII). The following considerations should be addressed:
    • NTDs may have already occurred;
    • Depending on the current gestational age, the additional risk of NTDs developing during the remaining time in first trimester may be small;
    • There is a background risk of NTDs regardless of antiretroviral treatment (ART) regimen or HIV status (this risk ranges from 0.05% to 0.1% for women without HIV, and women with HIV who are receiving ART that does not include dolutegravir); and
    • Changes in ART, even in the first trimester, are often associated with viral rebound that may increase the risk of perinatal HIV transmission.
  • Dolutegravir is a preferred integrase strand transfer inhibitor for use in pregnant women after the first trimester;b this designation is based on available PK, safety, and efficacy data (AII).
  • When dolutegravir use is continued after delivery, clinicians should recommend the use of postpartum contraception and discuss contraceptive options with patients (AIII).
  • For additional information, see Interim Recommendations about the Use of Dolutegravir in Pregnancy in Recommendations for the Use of Antiretroviral Drugs During Pregnancy and the Adult and Adolescent Antiretroviral Guidelines.
Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = One or more randomized trials with clinical outcomes and/or validated laboratory endpoints; II = One or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes; III = Expert opinion
a These are intended to be conservative, interim recommendations and will be revised, if indicated, as additional data become available in 2019.
b The first trimester is less than 14 weeks (up to 13 6/7 weeks) gestational age by last menstrual period. The term “12 weeks post-conception,” used in the Adult and Adolescent ARV Guidelines, is consistent with the first trimester.
c Although dolutegravir is not Food and Drug Administration-approved for use in the first trimester, some Perinatal Panel members would consider using dolutegravir at 12 weeks gestational age by last menstrual period on an individual patient basis.

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