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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 &amp;gt;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.<\/jats:p>","DOI":"10.1093\/ofid\/ofag537","type":"journal-article","created":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T11:39:33Z","timestamp":1787657973000},"source":"Crossref","is-referenced-by-count":0,"title":["IMPAACT 2041: Designing the Study of Glecaprevir\/Pibrentasvir Treatment During Pregnancy"],"prefix":"10.1093","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9921-0419","authenticated-orcid":false,"given":"Ravi","family":"Jhaveri","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Ann & Robert H. 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Chan School of Public Health , Boston, Massachusetts ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia M","family":"Flynn","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, St. Jude Children's Research Hospital , Memphis, Tennessee ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathan","family":"Furukawa","sequence":"additional","affiliation":[{"name":"National Center for HIV\/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention , Atlanta, Georgia ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahizechukwu C","family":"Eke","sequence":"additional","affiliation":[{"name":"Division of Maternal Fetal Medicine, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"IMPAACT 2041 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