Anti-HIV drugs in pregnancy not linked to children’s language delays

The combinations of anti-HIV drugs recommended for pregnant women do not appear in general to increase their children’s risk for language delay, according to a study from a National Institutes of Health research network.

Children exposed to HIV in the womb and whose mothers received combinations of anti-HIV drugs during pregnancy were no more likely to have language delays than were children exposed to HIV in the womb and whose mothers did not receive these recommended treatments, the study found.  In both groups, about 25 percent of the children had language delays by 2 years of age, suggesting that the delays were not associated with the anti-HIV drugs taken during pregnancy.

The findings allay concerns in the medical community that the drug combinations could affect the developing fetal brain in ways that cause language delays. Typically, these combination treatments include three or more drugs from at least two drug classes.  For a woman who is HIV-positive and pregnant, recommended combination therapies treat the infection and greatly reduce the chance that the virus will spread to the fetus. Previous studies suggested that the drugs used to treat pregnant women might contribute to language delays in infants and toddlers, even those who remained HIV-negative.

However, the researchers concluded that one drug sometimes used in the combination treatments should be monitored.  Children whose mothers received combination therapy containing the drug atazanavir were more likely to have language delays at 1 year of age than were the other children in the study.  These children appeared to catch up to their peers. The researchers noted that these effects were not seen in children in the atazanavir group at age 2. 

“Anti-HIV combination therapies do not appear to be linked to language delays, but it’s prudent to monitor  children exposed to HIV in the womb for signs of language delay,” said study co-author George Siberry, M.D., of the Maternal and Pediatric Infectious Disease Branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), one of the NIH institutes that conducted the study.  “Until there is a better understanding of what contributes to the delays, it’s important to monitor the language development of children in this group carefully, and refer them for language therapy at the first sign of a delay.”

Dr. Siberry collaborated with first author Mabel L. Rice, Ph.D., of the University of Kansas, Lawrence; Paige L. Williams, Ph.D., of the Harvard School of Public Health, Boston; Howard J. Hoffman, of the National Institute on Deafness and Other Communication Disorders (NIDCD), part of NIH; and colleagues at the National Institute of Mental Health (NIMH), also part of NIH; Albert Einstein College of Medicine, New York City; Northwestern University Feinberg School of Medicine, Chicago; Keck School of Medicine of the University of Southern California, Los Angeles; and Tulane University School of Medicine, New Orleans.

In addition to the NICHD, NIDCD and NIMH, seven NIH institutes and funding agencies supported the study: National Institute on Drug Abuse, National Institute of Allergy and Infectious Diseases, Office of AIDS Research, National Institute of Neurological Disorders and Stroke, National Heart, Lung and Blood Institute, National Institute of Dental and Craniofacial Research, and National Institute on Alcohol Abuse and Alcoholism.

The findings appear online in the Pediatric Infectious Disease Journal.

As part of an ongoing protocol known as the Pediatric HIV/AIDS Cohort Study, the researchers examined the effect of typical combination treatments.

Around the time of the children’s first and second birthdays, the researchers administered questionnaires to caregivers, asking them to assess their child’s language development.  At age 1, the caregivers indicated whether their children could respond to a list of simple words, and whether they could point with a finger or make other gestures to communicate.  The assessment for 2-year-olds asked caregivers to choose words the child had spoken or responded to, as well as other milestones of language use common to children at this age. 

The researchers evaluated the language skills of nearly 800 children.  They were able to collect assessments at study visits at either ages 1 or 2 for 70 percent of the children, and 40 percent were assessed at BOTH ages 1 and 2.

The researchers found that 26 percent of the 1-year-olds were significantly behind typical children their age with regard to emerging language skills.  Communicating at age 2 requires a different set of skills, as words increasingly replace gestures.  Yet, communication among 23 percent of 2-year-olds, too, was significantly delayed, compared with peers, the researchers found.

The researchers also conducted an analysis of individual drugs in the combination treatments the mothers received.  Atazanavir is among the preferred medications for the treatment of pregnant women, and its use is increasing, the authors noted.  Mothers of about 20 percent of the children in the study took this drug as part of their treatment.  The researchers found that 1-year-olds who had been exposed to atazanavir were nearly twice as likely to experience language delays as those who were exposed to combination regimens without atazanavirs.  However, they did not find evidence of increased language delays among the 2-year-olds whose mothers took atazanavir.


About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Institute’s website at  

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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