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

Penta Clinical Pharmacology Working Group; PADO-HIV 5 participants

doi:10.1016/S2352-3018(22)00121-7

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

Penta Clinical Pharmacology Working Group, PADO-HIV 5 participants

Research output: Contribution to journal › Review article › peer-review

12 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 language	English
Pages (from-to)	e649-e657
Journal	The Lancet HIV
Volume	9
Issue number	9
DOIs	https://doi.org/10.1016/S2352-3018(22)00121-7
Publication status	Published - Sept 2022

Bibliographical note

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

Funding

AB has received honoraria from Sandoz, and trial grants from National Institute of Health and UNITAID. AC has received honoraria from Merck Sharp and Dohme, paid to her institution, and trial grants from ViiV Healthcare, Gilead, and Merck, paid to her institution. All other authors declare no competing interests.

Funders	Funder number
UNITAID
National Institutes of Health

ASJC Scopus Subject Areas

Epidemiology
Immunology
Infectious Diseases
Virology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/S2352-3018(22)00121-7

Cite this

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

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.",

author = "{Penta Clinical Pharmacology Working Group} and {PADO-HIV 5 participants} and Jacobs, {Tom G.} and Stef Schouwenburg and Martina Penazzato and Moherndran Archary and Ruel, {Theodore D.} and {van den Anker}, John and Burger, {David M.} and Cressey, {Tim R.} and Abrams, {Elaine J.} and Hermione Lyall and Adrie Bekker and Angela Colbers and David Burger and Tim Cressey and Deborah Hirt and Irja Lutsar and Helen Mcilleron and Joe Standing and Elin Svensson and Elaine Abrams and Pauline Amuge and Mo Archary and Yodit Belew and Brookie Best and Helen Bygrave and Edmund Capparelli and Esther Casas and Diana Clarke and Polly Clayden and Mutsa Dangarembizi and {De Lisa}, Roberto and Paolo Denti and Paul Domanico and Shaffiq Essajee and Lisa Frigati and Carlo Giaquinto and Diana Gibb and Stephanie Hackett and Rohan Hazra and Marc Lallemant and Linda Lewis and Shahin Lockman and Imelda Mahaka and Betsy McFarland and Cathal Meere and Fatima Mir and Mark Mirochnick and Lynne Mofenson and Irene Mukui and Angela Mushavi",

year = "2022",

month = sep,

doi = "10.1016/S2352-3018(22)00121-7",

language = "English",

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journal = "The Lancet HIV",

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T2 - accelerating access to current and novel antiretroviral drugs in neonates through pharmacokinetic studies

AU - Penta Clinical Pharmacology Working Group

AU - PADO-HIV 5 participants

AU - Jacobs, Tom G.

AU - Schouwenburg, Stef

AU - Penazzato, Martina

AU - Archary, Moherndran

AU - Ruel, Theodore D.

AU - van den Anker, John

AU - Burger, David M.

AU - Cressey, Tim R.

AU - Abrams, Elaine J.

AU - Lyall, Hermione

AU - Bekker, Adrie

AU - Colbers, Angela

AU - Burger, David

AU - Cressey, Tim

AU - Hirt, Deborah

AU - Lutsar, Irja

AU - Mcilleron, Helen

AU - Standing, Joe

AU - Svensson, Elin

AU - Abrams, Elaine

AU - Amuge, Pauline

AU - Archary, Mo

AU - Belew, Yodit

AU - Best, Brookie

AU - Bygrave, Helen

AU - Capparelli, Edmund

AU - Casas, Esther

AU - Clarke, Diana

AU - Clayden, Polly

AU - Dangarembizi, Mutsa

AU - De Lisa, Roberto

AU - Denti, Paolo

AU - Domanico, Paul

AU - Essajee, Shaffiq

AU - Frigati, Lisa

AU - Giaquinto, Carlo

AU - Gibb, Diana

AU - Hackett, Stephanie

AU - Hazra, Rohan

AU - Lallemant, Marc

AU - Lewis, Linda

AU - Lockman, Shahin

AU - Mahaka, Imelda

AU - McFarland, Betsy

AU - Meere, Cathal

AU - Mir, Fatima

AU - Mirochnick, Mark

AU - Mofenson, Lynne

AU - Mukui, Irene

AU - Mushavi, Angela

PY - 2022/9

Y1 - 2022/9

N2 - 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.

AB - 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.

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U2 - 10.1016/S2352-3018(22)00121-7

DO - 10.1016/S2352-3018(22)00121-7

M3 - Review article

C2 - 35863363

AN - SCOPUS:85137074887

SN - 2352-3018

VL - 9

SP - e649-e657

JO - The Lancet HIV

JF - The Lancet HIV

IS - 9

ER -

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

Abstract

Bibliographical note

Funding

ASJC Scopus Subject Areas

UN SDGs

Access to Document

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Cite this