Authors
Ravi Jhaveri, Kristina M Brooks, Vincent Mainella, John Marcinak, Mong-Jen Chen, Katie McCarthy, Camlin Tierney, Zhongli J Zhang, Bryan S Nelson, Patricia M Flynn, Nathan Furukawa, Ahizechukwu C Eke, IMPAACT 2041 Protocol Team
Published in
Open forum infectious diseases. Volume 13. Issue 9. Pages ofag537. Epub Aug 28, 2026.
Abstract
The significant increase in hepatitis C virus (HCV) infection prevalence among young adults, including those who may become pregnant, has led to a corresponding increase in the number of infants exposed to and infected with HCV. Despite a recommendation for universal HCV screening during pregnancy, there is not always a clear pathway to immediately initiate treatment for maternal cure, which could also prevent vertical transmission like the approach for human immunodeficiency virus (HIV) or hepatitis B virus. In 2019, the American Association for the Study of Liver Diseases/Infectious Diseases Society of America HCV Guidelines panel endorsed the use of shared decision making between providers and patients when considering HCV treatment during pregnancy. Direct-acting antivirals, including glecaprevir/pibrentasvir (GLE/PIB), have been tremendously effective in curing >95% of individuals who begin treatment along with an overall well-characterized safety profile, but data supporting their use when initiated during pregnancy are more limited. International Maternal Pediatric Adolescent AIDS Clinical Trials 2041 is a multicenter single-arm phase I/II clinical trial designed to evaluate the pharmacokinetics and safety of GLE/PIB treatment initiated in pregnant women with HCV mono-infection or HCV/HIV co-infection. In this paper, we describe the relevant background data assembled from various sources to write the protocol and design the study.
PMID:
42703521
Bibliographic data and abstract were imported from PubMed on 07 Sep 2026.
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