{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T23:19:38Z","timestamp":1784848778154,"version":"3.55.0"},"reference-count":27,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"6","license":[{"start":{"date-parts":[[2021,8,26]],"date-time":"2021-08-26T00:00:00Z","timestamp":1629936000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:sec>\n            <jats:title>Background and Aims<\/jats:title>\n            <jats:p>Multiple direct\u2010acting antiviral (DAA) regimens are available to treat HCV genotype 1 infection. However, comparative effectiveness from randomized controlled trials of DAA regimens is unavailable.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Approach and Results<\/jats:title>\n            <jats:p>We conducted a pragmatic randomized controlled trial (NCT02786537) to compare the effectiveness of DAAs for HCV genotype 1a or 1b on viral response, safety, tolerability, and medication nonadherence. Adults with compensated liver disease, HCV genotype 1, not pregnant or breastfeeding, and with health insurance likely to cover ledipasvir\/sofosbuvir (LDV\/SOF) were recruited from 34 US viral hepatitis clinics. Participants were randomized (\u00b1 ribavirin) to LDV\/SOF, elbasvir\/grazoprevir (EBR\/GZR), and paritaprevir\/ritonavir\/ombitasvir+dasabuvir (PrOD; treatment arm stopped early). Primary outcomes included sustained viral response at 12\u00a0weeks (SVR12), clinician\u2010recorded adverse events, patient\u2010reported symptoms, and medication nonadherence. Between June 2016 and March 2018, 1,609 participants were randomized. Among 1,128 participants who received \u22651 dose of EBR\/GZR or LDV\/SOF (\u00b1 ribavirin), SVR12 was 95.2% (95% CI, 92.8%\u201097.6%) and 97.4% (95% CI, 95.5%\u201099.2%), respectively, with a difference estimate of 2.2% (\u22120.5% to 4.7%), falling within the \u201cequivalence\u201d interval (\u22125% to\u00a05%). While most (56%) participants experienced adverse events, few were serious (4.2%) or severe (1.8%). In the absence of ribavirin, discontinuations due to adverse events were rare. Patient\u2010reported symptoms and medication nonadherence were similar. Study limitations were dropout due to insurance denial and loss to follow\u2010up after treatment, limiting the ability to measure SVR12.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>This pragmatic trial demonstrated high SVR12 for participants treated with EBR\/GZR and LDV\/SOF with few adverse effects. Overall, the two regimens were equivalent in effectiveness. The results support current HCV guidelines that do not distinguish between ribavirin\u2010free EBR\/GZR and LDV\/SOF.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1002\/hep.32053","type":"journal-article","created":{"date-parts":[[2021,7,13]],"date-time":"2021-07-13T11:47:15Z","timestamp":1626176835000},"page":"2952-2964","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":13,"title":["A Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C: The PRIORITIZE Study"],"prefix":"10.1097","volume":"74","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2145-6352","authenticated-orcid":false,"given":"Mark S.","family":"Sulkowski","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases,Johns Hopkins University School of Medicine,Baltimore,MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juhi 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NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joy","family":"Peter","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology & Nutrition,University of Florida,Gainesville,FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Summer","family":"Wadsworth","sequence":"additional","affiliation":[{"name":"PRIORITIZE Patient Engagement Group consultant,Garner, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"Kixmiller","sequence":"additional","affiliation":[{"name":"PRIORITIZE Patient Engagement Group consultant,Greensboro, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anquenette","family":"Sloan","sequence":"additional","affiliation":[{"name":"PRIORITIZE Patient Engagement Group consultant,Pittsboro, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monika","family":"Vainorius","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology,University of North Carolina at Chapel Hill,Chapel Hill,NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick M.","family":"Horne","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology & Nutrition,University of Florida,Gainesville,FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Larry","family":"Michael","sequence":"additional","affiliation":[{"name":"Department of Biostatistics,University of North Carolina at Chapel Hill, Chapel Hill, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meichen","family":"Dong","sequence":"additional","affiliation":[{"name":"Department of Biostatistics,University of North Carolina at Chapel Hill, Chapel Hill, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donna M.","family":"Evon","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology,University of North Carolina at Chapel Hill,Chapel Hill,NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jodi B.","family":"Segal","sequence":"additional","affiliation":[{"name":"Division of Internal Medicne,Johns Hopkins University School of Medicine,Baltimore,MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David R.","family":"Nelson","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Hepatology & Nutrition,University of Florida,Gainesville,FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf ofthe PRIORITIZE Study Team","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2021,8,26]]},"reference":[{"key":"hep32053-bib-0001-20250824","first-page":"161","article-title":"Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study","volume":"2017","year":"2015","journal-title":"Lancet Gastroenterol 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