Optimizing Pharmacology Studies in Pregnant and Lactating Women Using Lessons From HIV: A Consensus Statement

the participants of the WHO-IMPAACT workshop on “Approaches to Optimize and Accelerate Pharmacokinetic Studies in Pregnant and Lactating Women”

Résultat de rechercheexamen par les pairs

29 Citations (Scopus)

Résumé

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.

Langue d'origineEnglish
Pages (de-à)36-48
Nombre de pages13
JournalClinical Pharmacology and Therapeutics
Volume110
Numéro de publication1
DOI
Statut de publicationPublished - juill. 2021

Financement

Overall support for the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) was provided by the National Institute of Allergy and Infectious Diseases (NIAID) with cofunding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH), all components of the National Institutes of Health (NIH), under Award Numbers UM1AI068632 (IMPAACT LOC), UM1AI068616 (IMPAACT SDMC) and UM1AI106716 (IMPAACT LC), and by NICHD contract number HHSN275201800001I. Overall support for the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) was provided by the National Institute of Allergy and Infectious Diseases (NIAID) with cofunding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH), all components of the National Institutes of Health (NIH), under Award Numbers UM1AI068632 (IMPAACT LOC), UM1AI068616 (IMPAACT SDMC) and UM1AI106716 (IMPAACT LC), and by NICHD contract number HHSN275201800001I. List of participants and speakers (including authors now): Elaine Abrams, Grace Aldrovandi, Adrie Bekker, Yodit Belew, 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, Xiaomei Liu (Mae), Shahin Lockman, Imelda Mahaka, Lindsay McKenna, Mark Mirochnick, Lynne Mofenson, Jeremiah Momper, Grace Montepiedra, Sharon Nachman, Clemensia Nakabiito, Bernadette Ng’eno, Adeniyi Olagunju, Martina Penazzato, Jeanna Piper, Helena Rabie, Theodore Ruel, Leyla Sahin, Kimberly Scarsi, David Shapiro, Alice Stek, Kimberly Struble, Graham Taylor, Marije van Schalkwijk, Raman Venkataramanan, Catriona Waitt, Sheryl Zwerski. A.C.: Research grant support from ViiV Healthcare, Gilead Sciences, Janssen Research, and Merck, paid to the institution. M.M.: Research grant support from ViiV Healthcare, Gilead Sciences, and Merck & Co, paid to the institution. J.M.: Research grant support from Gilead Sciences and Veloxis Pharmaceuticals. J.J.K.: Research support (paid to institution) from Gilead Sciences and ViiV Healthcare. All other authors declared no competing interests for this work.

Bailleurs de fondsNuméro du bailleur de fonds
International Maternal Pediatric Adolescent AIDS Clinical Trials Network
National Institutes of HealthHHSN275201800001I, UM1AI106716
National Institute of Mental Health
National Institute of Allergy and Infectious DiseasesUM1AI068616, UM1AI068632
National Institute of Child Health and Human DevelopmentK23HD104517
Janssen Research and Development
Gilead Sciences
Eunice Kennedy Shriver National Institute of Child Health and Human Development
ViiV Healthcare
Veloxis Pharmaceuticals
International Maternal Pediatric Adolescent AIDS Clinical Trials Network

    ASJC Scopus Subject Areas

    • Pharmacology
    • Pharmacology (medical)

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