{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,2]],"date-time":"2026-02-02T07:46:18Z","timestamp":1770018378248,"version":"3.49.0"},"reference-count":14,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2015,9,10]],"date-time":"2015-09-10T00:00:00Z","timestamp":1441843200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004334","name":"Merck","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004334","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2016,2]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Grazoprevir (<jats:styled-content style=\"fixed-case\">MK<\/jats:styled-content>\u20105172, Merck &amp; Co., Inc.) is a selective inhibitor of the hepatitis C virus (<jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content>) <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>3\/4a protease. The aim of this study was to evaluate the safety and efficacy of grazoprevir at doses of 25\u2013100\u00a0mg\/day in combination with peginterferon and ribavirin (<jats:styled-content style=\"fixed-case\">PEG<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">IFN<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content>). In this randomized, dose\u2010ranging, multicentre trial, treatment\u2010naive adults with chronic <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content> genotype 1 infection received once\u2010daily grazoprevir 25\u00a0mg, 50\u00a0mg or 100\u00a0mg plus <jats:styled-content style=\"fixed-case\">PEG<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">IFN<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content> for 12\u00a0weeks. Patients with quantifiable <jats:styled-content style=\"fixed-case\">HCV RNA<\/jats:styled-content> (\u226525\u00a0IU\/mL) at week 4 received an additional 12\u00a0weeks of <jats:styled-content style=\"fixed-case\">PEG<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">IFN<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">RBV<\/jats:styled-content>. The primary endpoint was sustained virologic response (<jats:styled-content style=\"fixed-case\">HCV RNA<\/jats:styled-content> &lt;25\u00a0IU\/mL 12\u00a0weeks after completing therapy [<jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12]). Eighty\u2010seven patients were randomly assigned and received \u22651 dose of therapy. Median time to undetectable <jats:styled-content style=\"fixed-case\">HCV RNA<\/jats:styled-content> was 16\u00a0days in the 100\u2010mg arm and 22\u00a0days in the 25\u2010 and 50\u2010mg arms. All patients except one had <jats:styled-content style=\"fixed-case\">HCV RNA<\/jats:styled-content> undetectable or unquantifiable at week 4 and received 12\u00a0weeks of therapy. <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 was achieved by 13 of 24 (54.2%), 21 of 25 (84.0%) and 23 of 26 (88.5%) patients in the 25\u2010, 50\u2010 and 100\u2010mg arms, respectively (per\u2010protocol analysis). Three patients discontinued as a result of nonserious adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s) and three patients experienced serious <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s. Transaminase elevations occurred in two patients (one each in the 25\u2010 and 100\u2010mg arms). <jats:italic>Conclusion:<\/jats:italic> These data support further study of the grazoprevir 100\u2010mg dose. Phase 3 studies of grazoprevir 100\u00a0mg in combination with elbasvir are currently ongoing (NCT01710501; protocol P038).<\/jats:p>","DOI":"10.1111\/jvh.12464","type":"journal-article","created":{"date-parts":[[2015,9,10]],"date-time":"2015-09-10T22:04:57Z","timestamp":1441922697000},"page":"80-88","source":"Crossref","is-referenced-by-count":12,"title":["Grazoprevir plus peginterferon and ribavirin in treatment\u2010naive patients with hepatitis C virus genotype 1 infection: a randomized trial"],"prefix":"10.1111","volume":"23","author":[{"given":"M.","family":"Lagging","sequence":"first","affiliation":[{"name":"Institute of Biomedicine at Sahlgrenska Academy University of Gothenburg Gothenburg Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Brown","sequence":"additional","affiliation":[{"name":"Imperial College Healthcare NHS Trust St Mary's Hospital London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P. S.","family":"Mantry","sequence":"additional","affiliation":[{"name":"The Liver Institute at Methodist Dallas Medical Center Dallas TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Ramji","sequence":"additional","affiliation":[{"name":"University of British Columbia Vancouver BC Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"F.","family":"Weilert","sequence":"additional","affiliation":[{"name":"Waikato District Health Board Hamilton New Zealand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. M.","family":"Vierling","sequence":"additional","affiliation":[{"name":"Baylor College of Medicine Houston TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A.","family":"Howe","sequence":"additional","affiliation":[{"name":"Merck &amp; Co. Inc. Kenilworth NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"suffix":"III","given":"I. 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