Media Advisory: Many pregnant women with HIV prescribed treatment that does not meet federal guidelines

NIH-funded researchers call for more studies on antiretroviral drug prescriptions during pregnancy

Side view of the torso of a pregnant woman holding a medicine bottle in one hand and pills in the other.
Credit: National Institutes of Health photography


More than 20% of pregnant women beginning anti-HIV treatment were prescribed an antiretroviral treatment that did not meet federal guidelines for use during pregnancy, according to an analysis funded by the National Institutes of Health. The study was led by Kathleen M. Powis, M.D., of Massachusetts General Hospital, Boston. It appears in JAMA Network Open.

The researchers analyzed data on women enrolled from 2008-2017 in the Surveillance Monitoring for ART Toxicities in HIV Uninfected Children Born to HIV Infected Women (SMARTT) study. Conducted in 18 U.S. research hospitals, SMARTT enrolled women living with HIV during pregnancy or at delivery. They compared each woman’s HIV treatment regimen to the U.S. Centers for Disease Control and Prevention’s treatment guidelines (PDF 27.6 MB), which classify treatment as preferred (safe for pregnant women), alternative (no known safety concerns in pregnancy), insufficient data for use in pregnancy, and not recommended for pregnancy except in special circumstances.

Of 1,867 women who began anti-HIV treatment before pregnancy, only 925 (49.5%) were prescribed regimens designated as preferred or alternative. Another 492 (26.4%) were prescribed regimens with insufficient data, and 136 (7.3%) were prescribed regimens not recommended for use during pregnancy. Of 452 women who began treatment during pregnancy, 91 (20.1%) were prescribed therapies with insufficient data or that were not recommended. The study authors called for additional studies to determine reasons why prescribing practices for pregnant women living with HIV may not align with current treatment guidelines.

Funding for the study was provided by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute on Drug Abuse, National Institute of Allergy and Infectious Diseases, Office of AIDS Research, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute on Deafness and Other Communication Disorders, National Institute of Dental and Craniofacial Research, and National Institute on Alcohol Abuse and Alcoholism.


Denise Russo, Ph.D., in the NICHD Maternal and Pediatric Infectious Disease Branch, is available for comment.


Powis, K.M. Antiretroviral prescribing practices among pregnant women living with HIV in the United States, 2008-17. JAMA Network Open. 2019.


About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD leads research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. For more information, visit

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit

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