Updated HHS Perinatal Antiretroviral Treatment Guidelines Released

This report originally appeared on nih.gov. To view the full report, click here.

The HHS Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission (the Panel) is pleased to announce the release of the updated Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States.

Key updates to the guidelines include the following:

  • The Panel has updated the recommendations on the use of dolutegravir (DTG) in pregnant women and women who are trying to conceive based on data available as of August 2019. Restrictions on the use of DTG during the first trimester and in women who are trying to conceive have been removed. DTG is now a Preferred antiretroviral (ARV) drug throughout pregnancy and an Alternative ARV drug for women who are trying to conceive.
  • In a number of sections, the Panel emphasizes the importance of patient counseling and recommends supporting informed decision-making regarding the use of DTG and other ARV drugs for women who are pregnant or who are trying to conceive. A counseling guide has been added to summarize the content that should be discussed with patients; this new section is titled Appendix D: Dolutegravir Counseling Guide for Health Care Providers.
  • In Recommendations for Use of Antiretroviral Drugs During Pregnancy, the Panel has updated the definitions for the Preferred and Alternative categories of ARV drugs recommended for use in pregnancy and in women who are trying to conceive. In addition, the Panel recommends that all pregnant women and women who might conceive should take at least 400 mcg of folic acid daily.
  • A new section was added to Teratogenicity with data about the association between integrase strand transfer inhibitors (INSTIs) and birth defects. This section was also updated to include recent data about an increased rate of microcephaly in HIV-exposed but uninfected children with in utero efavirenz exposure.
  • Combination Antiretroviral Drug Regimens and Maternal and Neonatal Outcomes was revised and reorganized to focus on data regarding preterm birth, fetal growth restriction, miscarriage, and stillbirth that has been published since 2015. This section also discusses data about hypertensive disorders of pregnancy and maternal HIV.
  • Lack of Viral Suppression now states that, after reviewing a woman’s full treatment history and drug resistance test results, a clinician may consider using an INSTI as part of a new regimen for a pregnant woman who is experiencing virologic failure on an ARV regimen that does not contain an INSTI.
  • Older ARV drugs that the Panel does not recommend for use in pregnant women or women who are trying to conceive because of unacceptable toxicities, inferior virologic efficacy, high pill burden, pharmacologic concerns, and/or limited data about use in pregnancy have been moved to a new section in Appendix B titled Archived Drugs; data about these drugs will no longer be reviewed by the Panel.

For a complete list of updates, please see What’s New in the Guidelines. Additions and revisions are highlighted in yellow throughout the PDF version of the guidelines.

To view or download the guidelines, go to the Perinatal Guidelines section of AIDSinfo’s website. The guideline tables and recommendations can also be downloaded as separate PDF files.