1. What babies need
- Author
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Tom G Jacobs, Stef Schouwenburg, Martina Penazzato, Moherndran Archary, Theodore D Ruel, John van den Anker, David M Burger, Tim R Cressey, Elaine J Abrams, Hermione Lyall, Adrie Bekker, Angela Colbers, David Burger, Tim Cressey, Deborah Hirt, Irja Lutsar, Helen Mcilleron, Joe Standing, John Van den Anker, Elin Svensson, Elaine Abrams, Pauline Amuge, Mo Archary, Yodit Belew, Brookie Best, Helen Bygrave, Edmund Capparelli, Esther Casas, Diana Clarke, Polly Clayden, Mutsa Dangarembizi, Roberto De Lisa, Paolo Denti, Paul Domanico, Shaffiq Essajee, Lisa Frigati, Carlo Giaquinto, Diana Gibb, Stephanie Hackett, Rohan Hazra, Marc Lallemant, Linda Lewis, Shahin Lockman, Imelda Mahaka, Betsy McFarland, Cathal Meere, Fatima Mir, Mark Mirochnick, Lynne Mofenson, Irene Mukui, Angela Mushavi, Victor Musiime, Eleanor Namusoke-Magongo, Elisabeth Obimbo, Mary Atieno Ojoo, Roger Parades, Carmen Perez-Casas, Manuele Piccolis, Jorge Pinto, Thanyawee Puthanakit, Natella Rakhmanina, Annette Reinisch, Pablo Rojo, Vanessa Rouzier, Ted Ruel, Nadia Sam-Agudu, George Siberry, Teresa Simione, Katie Simon, Vindi Singh, Manjari Solares, Nandita Sugandhi, Mariam Sylla, Ibou Thior, Anna Turkova, Marissa Vicari, Jenny Walsh, Melynda Watkins, Hilary Wolf, Asma Hafiz, Ajay Rangaraj, Meg Doherty, and Marco Vitoria
- Subjects
Adult ,Epidemiology ,Anti-HIV Agents ,Immunology ,Infant, Newborn ,Infant ,HIV Infections ,Anti-Retroviral Agents ,Female ,Humans ,Pharmaceutical Preparations ,Newborn ,Infectious Diseases ,lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4] ,SDG 3 - Good Health and Well-being ,Virology - Abstract
Item does not contain fulltext 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.
- Published
- 2022
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