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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Recommendations for Use of Antiretroviral Drugs During Pregnancy

Overview

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

Panel's Recommendations for the Use of Antiretroviral Drugs During Pregnancy
Panel's Recommendations
  • Multiple factors must be considered when choosing an antiretroviral (ARV) drug regimen for a pregnant woman. These factors include the adverse effects, drug interactions, pharmacokinetics (PKs), convenience of individual drugs and drug combinations in the regimen, experience with the use of these drugs in pregnancy, and the patient’s resistance test results and comorbidities (AIII).
  • In general, the same regimens that are recommended for the treatment of nonpregnant adults should be used in pregnant women when sufficient data suggest that appropriate drug exposure is achieved during pregnancy, unless there are known adverse effects for women, fetuses, or infants that outweigh the benefits if these regimens (AII).
  • In most cases, women who present for obstetric care on fully suppressive ARV regimens should continue their current regimens (AIII).
  • PK changes in pregnancy may lead to lower plasma levels of drugs and necessitate increased dosages, more frequent dosing, boosting, or more frequent viral load monitoring (AII).

Interim Panel Recommendations Regarding the Use of Dolutegravir in Pregnancy:a

  • Dolutegravir is not recommended for use in pregnant women during the first trimesterb,c and in nonpregnant women who are trying to conceive, due to concerns about a possible increased risk of neural tube defects (NTDs) (AIII).
  • 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).
  • 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.
  • 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 subsection below for Interim Guidance about the Use of Dolutegravir in Pregnancy and Teratogenicity.
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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