Safety Data Timelines for Pregnant Individuals With HIV on Antiretroviral Therapy.

This article focuses on the delay between U.S. Food and Drug Administration (FDA) approval of antiretroviral drugs (ARVs) and the availability of sufficient pregnancy safety data in the Antiretroviral Pregnancy Registry (APR), an international observational registry monitoring prenatal ARV exposure and birth defects. The study found a median delay of six years from FDA approval to inclusion of ARVs in the APR’s primary safety analysis, which requires at least 200 first-trimester exposures to detect increased birth defect risks. Despite widespread use of some ARVs, data remain limited or absent for newer drugs such as cabotegravir and those used in heavily treatment-experienced individuals, partly due to voluntary underreporting by healthcare providers. The article emphasizes the importance of timely and comprehensive pregnancy safety data to inform clinical decisions and calls for improved reporting practices to reduce delays in understanding ARV safety during pregnancy.