The authors noted that pregnant women are typically excluded from clinical trials investigating the safety and tolerability of HIV medications.
Antiretroviral medication (ARVs) prescribing practices for pregnant women living with HIV do not align with US national guidelines, according to a recent study published in JAMA Network Open.
The study investigated antiretroviral prescribing practices over time among pregnant women living with HIV and compared them to HHS treatment guidelines, in use since 1994, in order to identify factors associated with receiving recommended regimens. The researchers enrolled 1582 pregnant women living with HIV into the Pediatric HIV/AIDS Cohort Study Surveillance Monitoring of ART (antiretroviral therapy) Toxicities study between January 2008 to June 2017.
Of 1867 pregnancies among the women, antiretroviral medications were started before conception for 790 women (42.3%), resumed during pregnancy for 625 women (33.5%), and started during pregnancy for 452 women (24.2%). Only 925 pregnancies (49.5%) were linked with prescribed ARVs designated as preferred or alternative, while 492 (26.4%) involved ARVs with insufficient evidence for use during pregnancy and 136 (7.3%) involved ARVs that were not recommended during pregnancy.
“Our study demonstrates discordance between guideline recommendations and actual prescribing practices, even when prescribing for treatment-naive pregnant women living with HIV,” concluded the authors. “This finding may reflect the dilemma that pregnant women are typically excluded from clinical trials investigating the safety and tolerability of new ARV medications in an effort to protect the fetus, introducing increased lag time between US Food and Drug Administration approval of new drugs and data on which revisions to the guidelines for pregnant women living with HIV are justified.”
The researchers concluded that these findings emphasize the importance of conducting research that helps better understand determinants associated with prescribing practices that do not align with the guideline recommendations.
Powis K, Huo Y, Williams P, et al. Antiretroviral prescribing practices among pregnant women living with HIV in the United States, 2008-2017 [published online December 18, 2019]. JAMA Network Open. doi:10.1001/jamanetworkopen.2019.17669.