Safety Data Timelines for Pregnant Individuals with HIV on Antiretroviral Therapy

William R Short; Matty M Zimmerman; Ola Mohamed; Lynne M Mofenson

doi:10.1093/cid/ciae249

Safety Data Timelines for Pregnant Individuals with HIV on Antiretroviral Therapy

Clin Infect Dis. 2024 May 6:ciae249. doi: 10.1093/cid/ciae249. Online ahead of print.

Authors

William R Short¹, Matty M Zimmerman², Ola Mohamed¹, Lynne M Mofenson³

Affiliations

¹ Division of Infectious Diseases, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
² Department of Pharmacy, Penn Presbyterian Medical Center, Philadelphia, Pennsylvania, USA.
³ Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC, USA.

PMID: 38709816
DOI: 10.1093/cid/ciae249

Abstract

Antiretrovirals are often approved by the Food and Drug Administration without sufficient safety data regarding their use in pregnancy. To quantify this delay, we calculated the interval from the approval date to their inclusion in the Antiretroviral Pregnancy Registry prospective analysis (≥ 200 first trimester exposures); median delay was six years.

Keywords: HIV; antiretrovirals; birth defects; pregnancy; safety.

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