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Title: Optimizing Pharmacology Studies in Pregnant and Lactating Women Using Lessons from HIV: A Consensus Statement
Authors: Ahizechukwu C. Eke
Adeniyi Olagunju
Jeremiah Momper
Martina Penazzato
Elaine J. Abrams
Brookie M. Best
Edmund V. Capparelli
Adrie Bekker
Yodit Belew
Jennifer J. Kiser
Kimberly Struble
Graham Taylor
Catriona Waitt
Mark Mirochnick
Tim R. Cressey
Angela Colbers
Elaine Abrams
Grace Aldrovandi
Brookie Best
Roberta Black
Marta Boffito
Andrew Bremer
Kristina Brooks
David Burger
Edmund Capparelli
Nahida Chakhtoura
Lamek Chinula
Kulkanya Chokephaibulkit
Diana Clarke
Angela Colbers
Richard Court
Tim R. Cressey
Ahizechukwu Eke
Myriam El Gaaloul
Terrence Fenton
Rohan Hazra
Patrick Jean-Philippe
John Kinuthia
Jennifer Kiser
Regis Kreitchman
Mohammed Lamorde
Linda Lewis
Maggie Little
Keywords: Medicine
Pharmacology, Toxicology and Pharmaceutics
Issue Date: 1-Jan-2020
Abstract: © 2020 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. Information on the extent of drug exposure to mothers and infants during pregnancy and lactation normally becomes available years after regulatory approval of a drug. Clinicians face knowledge gaps on drug selection and dosing in pregnancy and infant exposure during breastfeeding. Physiological changes during pregnancy often result in lower drug exposures of antiretrovirals, and in some cases a risk of reduced virologic efficacy. The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) network and the World Health Organization (WHO)–convened Pediatric Antiretrovirals Working Group collaboratively organized a workshop of key stakeholders in June 2019 to define key standards to generate pharmacology data for antiretrovirals to be used among pregnant and lactating women; review the antiretroviral product pipeline; describe key gaps for use in low-income and middle-income countries; and identify opportunities to undertake optimal studies allowing for rapid implementation in the clinical field. We discussed ethical and regulatory principles, systemic approaches to obtaining data for pregnancy pharmacokinetic/pharmacodynamic (PK/PD) studies, control groups, optimal sampling times during pregnancy, and pharmacokinetic parameters to be considered as primary end points in pregnancy PK/PD studies. For lactation studies, the type of milk to collect, ascertainment of maternal adherence, and optimal PK methods to estimate exposure were discussed. Participants strongly recommended completion of preclinical reproductive toxicology studies prior to phase III, to allow study protocols to include pregnant women or to allow women who become pregnant after enrolment to continue in the trial. The meeting concluded by developing an algorithm for design and interpretation of results and noted that recruitment of pregnant and lactating women into clinical trials is critical.
ISSN: 15326535
Appears in Collections:CMUL: Journal Articles

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