{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,8]],"date-time":"2025-10-08T15:33:15Z","timestamp":1759937595105,"version":"3.37.3"},"reference-count":25,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2017,3,17]],"date-time":"2017-03-17T00:00:00Z","timestamp":1489708800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100003478","name":"Ministry of Health, Labour and Welfare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100003478","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2017,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background &amp; Aims<\/jats:title><jats:p>It is important to investigate the treatment outcomes in patients excluded from clinical trials (<jats:styled-content style=\"fixed-case\">CTR<\/jats:styled-content>). The aims of this study were to evaluate the efficacy and safety of a 24\u2010week daclatasvir (<jats:styled-content style=\"fixed-case\">DCV<\/jats:styled-content>) and asunaprevir (<jats:styled-content style=\"fixed-case\">ASV<\/jats:styled-content>) therapy for patients with chronic hepatitis C virus (<jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content>)\u20101b infection.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 651 <jats:styled-content style=\"fixed-case\">HCV<\/jats:styled-content>\u20101b patients started dual oral therapy with <jats:styled-content style=\"fixed-case\">DCV<\/jats:styled-content> and <jats:styled-content style=\"fixed-case\">ASV<\/jats:styled-content> for 24\u00a0weeks in Toranomon Hospital, Tokyo. Among them, 276 patients met phase <jats:styled-content style=\"fixed-case\">III CTR<\/jats:styled-content> inclusion criteria. The sustained virological response (<jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>) rate after treatment and the adverse events during therapy were compared between <jats:styled-content style=\"fixed-case\">CTR<\/jats:styled-content>\u2010met (patients who met the inclusion criteria) and <jats:styled-content style=\"fixed-case\">CTR<\/jats:styled-content>\u2010unmet (patients who did not meet the inclusion criteria) groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 was achieved in 87.0% (240\/276) and 86.7% (325\/375) in <jats:styled-content style=\"fixed-case\">CTR<\/jats:styled-content>\u2010met and CTR\u2010unmet patients respectively. <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 rate in simeprevir\u2010experienced patients was 52.9% (9\/17). <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 rate in patients without resistance\u2010associated variant (<jats:styled-content style=\"fixed-case\">RAV<\/jats:styled-content>) of <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>3 or <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>5A loci was 93.7% (416\/444). However, the <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 rates in patients with <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>3\u2010D168, <jats:styled-content style=\"fixed-case\">NS<\/jats:styled-content>5A\u2010L31 and Y93 single <jats:styled-content style=\"fixed-case\">RAV<\/jats:styled-content> at baseline were 55.0% (11\/20), 73.9% (17\/23) and 65.6% (63\/96) respectively. The safety profiles in both <jats:styled-content style=\"fixed-case\">CTR<\/jats:styled-content>\u2010met and CTR\u2010unmet patients were similar. The discontinuation rate as a result of alanine aminotransferase (<jats:styled-content style=\"fixed-case\">ALT<\/jats:styled-content>) elevation was only 2.9%. Seven (2.5%) patients in <jats:styled-content style=\"fixed-case\">CTR<\/jats:styled-content>\u2010met group and 20 (5.3%) in <jats:styled-content style=\"fixed-case\">CTR<\/jats:styled-content>\u2010unmet group discontinued therapy because of adverse events other than the <jats:styled-content style=\"fixed-case\">ALT<\/jats:styled-content> elevation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Dual oral therapy with <jats:styled-content style=\"fixed-case\">DCV<\/jats:styled-content> and <jats:styled-content style=\"fixed-case\">ASV<\/jats:styled-content> in real\u2010life settings was well tolerated with a similar safety profile and achieved similar <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 rates as that of <jats:styled-content style=\"fixed-case\">CTR<\/jats:styled-content>.<\/jats:p><\/jats:sec>","DOI":"10.1111\/liv.13384","type":"journal-article","created":{"date-parts":[[2017,2,8]],"date-time":"2017-02-08T21:27:18Z","timestamp":1486589238000},"page":"1325-1333","source":"Crossref","is-referenced-by-count":22,"title":["The efficacy and safety of dual oral therapy with daclatasvir and asunaprevir for genotype 1b in Japanese real\u2010life settings"],"prefix":"10.1111","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4282-0934","authenticated-orcid":false,"given":"Hitomi","family":"Sezaki","sequence":"first","affiliation":[{"name":"Department of Hepatology Toranomon Hospital  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fumitaka","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Department of Hepatology Toranomon Hospital  Tokyo Japan"},{"name":"Okinaka Memorial Institute for Medical Research  Tokyo 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