BOSTON - Women living with HIV who are also pregnant don't always receive recommended antiretroviral medications, according to a recent study of prescribing patterns carried out by a MassGeneral Hospital for Children (MGHfC) researcher in collaboration with other members of the Surveillance Monitoring for ART Toxicities (SMARTT) study of the Pediatric HIV/AIDS Cohort Study (PHACS) network. Few studies, if any, have compared actual prescribing patterns of HIV medications for pregnant women to national treatment guidelines. This study suggests that physicians may be prescribing ahead of the published recommendations, and using drugs or drug combinations they have seen work in the adult population in general.
"We studied, more than 1,500 women and found that 30 percent were prescribed drugs that had insufficient evidence of safety in pregnancy," says Kathleen M. Powis, MD, MPH, investigator in MGHfC's division of Pediatric Global Health and first author of the study, which was published in JAMA Network Open this week.
For the last 25 years, the US Department of Health and Human services Panel on Treatment of HIV-infected Pregnant Women and Prevention of Perinatal Transmission has published Perinatal HIV Treatment Guidelines on prescribing antiretroviral medications (ARVs) during pregnancy. In 1994, the guidelines just addressed the use of zidovudine, then the only drug approved to treat HIV infection. But by 2008 the prescribing guidelines for pregnant women were updated to recommend the use of triple ARVs, regardless of the woman's HIV disease status. Pregnant women are typically excluded from studies testing newer drugs until safety has been established in nonpregnant adults. As a result, this data is usually some of the last to be collected.
"The guidelines change nearly annually," says Powis, who is also an assistant professor of Pediatrics at Harvard Medical School (HMS). "And a lot of the treatments that doctors are already using simply had 'insufficient data' to recommend their use in pregnant women. But doctors were prescribing them anyway." Since many of these regimens (70%) were eventually recommended for pregnant women, Powis suggests that doctors may be prescribing "ahead of time." That is, they are seeing promising therapeutic results in the general population, and prescribing HIV drug treatment combinations to pregnant women based on that experience, rather than on guidelines.
The PHACS SMARTT study is a United States-based study funded by the National Institute of Child Health and Human Development.
About the Massachusetts General Hospital
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH Research Institute conducts the largest hospital-based research program in the nation, with an annual research budget of more than $1 billion and comprises more than 8,500 researchers working across more than 30 institutes, centers and departments. In August 2019 the MGH was once again named #2 in the nation by U.S. News & World Report in its list of "America's Best Hospitals."
JAMA Network Open