{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T22:20:01Z","timestamp":1775168401691,"version":"3.50.1"},"reference-count":16,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2017,3,8]],"date-time":"2017-03-08T00:00:00Z","timestamp":1488931200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002491","name":"Bristol-Myers Squibb","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002491","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>Optimally effective treatment for hepatitis C virus genotype 3\u00a0(GT3) is urgently needed, particularly in advanced liver disease. Daclatasvir plus sofosbuvir was efficacious in phase 3 studies. Real\u2010world data for daclatasvir+sofosbuvir in advanced <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>3 infection are presented from the French Temporary Authorisation for Use programme, which allowed patients in need without other treatment options access to daclatasvir ahead of its market authorization.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with F3\/F4 fibrosis and\/or extrahepatic hepatitis C virus manifestations, post\u2010liver transplant hepatitis C virus recurrence and\/or indication for liver\/kidney transplant, were treated with daclatasvir+sofosbuvir (60+400\u00a0mg daily) for a recommended duration of 24\u00a0weeks. Addition of ribavirin and\/or shorter treatment was at physician's discretion. The primary efficacy analysis was sustained virological response at post\u2010treatment week 12 (<jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12; modified intention\u2010to\u2010treat). Safety was assessed by spontaneous adverse event reporting.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The efficacy population comprised 333 patients, mostly cirrhotic (77%, of whom 18% were decompensated) and treatment experienced (72%). After 24\u00a0weeks of daclatasvir+sofosbuvir, SVR12 was 89% (174\/196) overall (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 83.6\u201092.5%), 98% (43\/44) without cirrhosis (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 88.2\u201099.6%) and 86% (129\/150) with any degree of cirrhosis (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 79.5\u201090.7%), without <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 increase in those who received additional ribavirin for 24\u00a0weeks (<jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 82% [50\/61; 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 70.5\u201089.6%]). Among 516 <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>3\u2010infected patients with safety data, 5 discontinued for adverse events and 11 died.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Daclatasvir+sofosbuvir achieved high <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 rates and was well tolerated in this large real\u2010world cohort of <jats:styled-content style=\"fixed-case\">GT<\/jats:styled-content>3\u2010infected patients with advanced liver disease, without benefit of ribavirin in those treated 24\u00a0weeks.<\/jats:p><\/jats:sec>","DOI":"10.1111\/liv.13383","type":"journal-article","created":{"date-parts":[[2017,2,8]],"date-time":"2017-02-08T10:52:52Z","timestamp":1486551172000},"page":"1314-1324","source":"Crossref","is-referenced-by-count":65,"title":["Daclatasvir plus sofosbuvir, with or without ribavirin, for hepatitis C virus genotype 3 in a French early access 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