{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T17:48:14Z","timestamp":1760550494821,"version":"3.27.0"},"reference-count":26,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"6","license":[{"start":{"date-parts":[[2018,4,19]],"date-time":"2018-04-19T00:00:00Z","timestamp":1524096000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"},{"start":{"date-parts":[[2018,4,19]],"date-time":"2018-04-19T00:00:00Z","timestamp":1524096000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:p>Many direct\u2010acting antiviral regimens have reduced activity in people with hepatitis C virus (HCV) genotype (GT) 3 infection and cirrhosis. The C\u2010ISLE study assessed the efficacy and safety of elbasvir\/grazoprevir (EBR\/GZR) plus sofosbuvir (SOF) with and without ribavirin (RBV) in compensated cirrhotic participants with GT3 infection. This was a phase 2, randomized, open\u2010label study. Treatment\u2010naive participants received EBR\/GZR\u2009+\u2009SOF\u2009+\u2009RBV for 8 weeks or EBR\/GZR\u2009+\u2009SOF for 12 weeks, and peginterferon\/RBV treatment\u2010experienced participants received EBR\/GZR\u2009+\u2009SOF\u2009\u00b1\u2009RBV for 12 weeks or EBR\/GZR\u2009+\u2009SOF for 16 weeks. The primary endpoint was HCV RNA &lt;15 IU\/mL 12 weeks after the end of treatment (sustained virologic response at 12 weeks [SVR12]). Among treatment\u2010naive participants, SVR12 was 91% (21\/23) in those treated with RBV for 8 weeks and 96% (23\/24) in those treated for 12 weeks. Among treatment\u2010experienced participants, SVR12 was 94% (17\/18) and 100% (17\/17) in the 12\u2010week arm, with and without RBV, respectively, and 94% (17\/18) in the 16\u2010week arm. Five participants failed to achieve SVR: 2 relapsed (both in the 8\u2010week arm), 1 discontinued due to vomiting\/cellulitis (16\u2010week arm), and 2 discontinued (consent withdrawn\/lost to follow\u2010up). SVR12 was not affected by the presence of resistance\u2010associated substitutions (RASs). There was no consistent change in insulin resistance, and 5 participants reported serious adverse events (pneumonia, chest pain, opiate overdose, cellulitis, decreased creatinine). High efficacy was demonstrated in participants with HCV GT3 infection and cirrhosis. Treatment beyond 12 weeks was not required, and efficacy was maintained regardless of baseline RASs. <jats:italic toggle=\"yes\">Conclusion<\/jats:italic>: Data from this study support the use of EBR\/GZR plus SOF for 12 weeks without RBV for treatment\u2010naive and peginterferon\/RBV\u2013experienced people with GT3 infection and cirrhosis (ClinicalTrials.gov NCT02601573). (H<jats:sc>epatology<\/jats:sc> 2018;67:2113\u20102126)<\/jats:p>","DOI":"10.1002\/hep.29852","type":"journal-article","created":{"date-parts":[[2018,2,23]],"date-time":"2018-02-23T20:05:21Z","timestamp":1519416321000},"page":"2113-2126","update-policy":"http:\/\/dx.doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":22,"title":["Elbasvir\/grazoprevir and sofosbuvir for hepatitis C virus genotype 3 infection with compensated cirrhosis: A randomized trial"],"prefix":"10.1097","volume":"67","author":[{"given":"Graham R.","family":"Foster","sequence":"first","affiliation":[{"name":"Queen Mary University,London,UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kosh","family":"Agarwal","sequence":"additional","affiliation":[{"name":"Institute of Liver Studies, Kings College Hospital,London,UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew E.","family":"Cramp","sequence":"additional","affiliation":[{"name":"South West Liver Unit, Derriford Hospital and Peninsula Schools of Medicine and Dentistry,Plymouth,UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sulleman","family":"Moreea","sequence":"additional","affiliation":[{"name":"Bradford Teaching Hospitals Foundation Trust,Bradford,UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Barclay","sequence":"additional","affiliation":[{"name":"Glasgow Royal Campus,Glasgow,UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane","family":"Collier","sequence":"additional","affiliation":[{"name":"John Radcliffe Hospital,Oxford,UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ashley S.","family":"Brown","sequence":"additional","affiliation":[{"name":"Imperial College Healthcare NHS Trust,London,UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen D.","family":"Ryder","sequence":"additional","affiliation":[{"name":"NIHR Biomedical Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospital NHS Trust and The University of Nottingham,Nottingham,UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Ustianowski","sequence":"additional","affiliation":[{"name":"North Manchester General Hospital,Manchester,UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel M.","family":"Forton","sequence":"additional","affiliation":[{"name":"St. Georges University of London,London,UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ray","family":"Fox","sequence":"additional","affiliation":[{"name":"Gartnavel General Hospital,Glasgow,UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fiona","family":"Gordon","sequence":"additional","affiliation":[{"name":"Hepatology Joint Clinical Research Unit,Bristol,UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William M.","family":"Rosenberg","sequence":"additional","affiliation":[{"name":"Institute for Liver and Digestive Health, University College London,London,UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David J.","family":"Mutimer","sequence":"additional","affiliation":[{"name":"QE Hospital,Birmingham,UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiejun","family":"Du","sequence":"additional","affiliation":[{"name":"Merck & Co.,Inc.,Kenilworth,NJ"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher L.","family":"Gilbert","sequence":"additional","affiliation":[{"name":"Merck & Co.,Inc.,Kenilworth,NJ"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ernest","family":"Asante\u2010Appiah","sequence":"additional","affiliation":[{"name":"Merck & Co.,Inc.,Kenilworth,NJ"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Janice","family":"Wahl","sequence":"additional","affiliation":[{"name":"Merck & 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