IMPAACT 2041: Designing the Study of Glecaprevir/Pibrentasvir Treatment During Pregnancy

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ID: 326853
2026
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Abstract
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 HIV or hepatitis B virus (HBV). In 2019, the AASLD/IDSA HCV Guidelines panel endorsed the use of shared decision making between providers and patients when considering HCV treatment during pregnancy. Direct acting antivirals (DAAs), 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. IMPAACT 2041 is a multicenter single-arm Phase I/II clinical trial designed to evaluate the pharmacokinetics (PK) 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.
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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, Renee Browning, Haley Brozik, Margaret Burroughs, Christine Chiou, Maria Corcorran, Emma Duffy, Molly Dyer, Alexandru Iacob, Cheryl Jennings, Vindya Kakarla, Jatinder Kaur, Sonia Lee, Philip Marzinek, Andrea McMunn, Talia Pindyck, Chitara Rowry, Hannah Small, Leah Spalding, Chelsea Stotz, Franklin Yates
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Journal Open forum infectious diseases
Year 2026
DOI
10.1093/ofid/ofag537
URL
https://doi.org/10.1093/ofid/ofag537
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