What babies need: accelerating access to current and novel antiretroviral drugs in neonates through pharmacokinetic studies

Tom G. Jacobs*, Stef Schouwenburg, Penta Clinical Pharmacology Working Group, PADO-HIV 5 participants, Martina Penazzato, Moherndran Archary, Theodore D. Ruel, John van den Anker, David Burger, Tim R. Cressey, Elaine J. Abrams, Hermione Lyall, Adrie Bekker, Angela Colbers

*Corresponding author for this work

Research output: Contribution to journalReview articleAcademicpeer-review

8 Citations (Scopus)

Abstract

Although 23 antiretroviral drugs are approved for use in adults, only six are approved by regulatory authorities for use in term neonates born to women with HIV, with even fewer options for preterm neonates. A major hurdle for approvals is the delay in the generation of pharmacokinetic and safety data for antiretrovirals in neonates. The median time between the year of approval from the US Food and Drug Administration of an antiretroviral agent for adults and the first publication date for pharmacokinetic data in neonates less than 4 weeks old is 8 years (range 2–23 years). In this Viewpoint, we address pharmacokinetic research gaps and priorities for current and novel antiretroviral use in neonates. We also consider the challenges and provide guidance on neonatal clinical pharmacology research on antiretroviral agents with the goal of stimulating research and expediting the availability of safe medications for the prevention and treatment of HIV in this vulnerable population.

Original languageEnglish
Pages (from-to)e649-e657
JournalThe Lancet HIV
Volume9
Issue number9
DOIs
Publication statusPublished - Sept 2022

Bibliographical note

Publisher Copyright: © 2022 World Health Organization. Published by Elsevier Ltd. All rights reserved

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