Safety Data Timelines for Pregnant Individuals With Human Immunodeficiency Virus (HIV) on Antiretroviral Therapy

Author:

Short William R1ORCID,Zimmerman Matty M2,Mohamed Ola1,Mofenson Lynne M3

Affiliation:

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

Abstract

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); the median delay was 6 years.

Publisher

Oxford University Press (OUP)

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