{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T00:28:03Z","timestamp":1791851283482,"version":"4.3.4"},"reference-count":37,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"5","license":[{"start":{"date-parts":[[2016,3,4]],"date-time":"2016-03-04T00:00:00Z","timestamp":1457049600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2016,5]]},"abstract":"<jats:p>Patients with hepatitis C virus (HCV) genotype 3 infection, especially those with advanced liver disease, are a challenging population in urgent need of optimally effective therapies. The combination of daclatasvir (DCV; pangenotypic nonstructural protein 5A inhibitor) and sofosbuvir (SOF; nucleotide nonstructural protein 5B inhibitor) for 12 weeks previously showed high efficacy (96%) in noncirrhotic genotype 3 infection. The phase III ALLY\u20103+ study (N = 50) evaluated DCV\u2010SOF with ribavirin (RBV) in treatment\u2010na\u00efve (n = 13) or treatment\u2010experienced (n = 37) genotype 3\u2010infected patients with advanced fibrosis (n = 14) or compensated cirrhosis (n = 36). Patients were randomized 1:1 to receive open\u2010label DCV\u2010SOF (60 + 400 mg daily) with weight\u2010based RBV for 12 or 16 weeks. The primary endpoint was sustained virological response at post\u2010treatment week 12 (SVR12). SVR12 (intention\u2010to\u2010treat) was 90% overall (45 of 50): 88% (21 of 24) in the 12\u2010week (91% observed) and 92% (24 of 26) in the 16\u2010week group. All patients with advanced fibrosis achieved SVR12. SVR12 in patients with cirrhosis was 86% overall (31 of 36): 83% (15 of 18) in the 12\u2010week (88% observed) and 89% (16 of 18) in the 16\u2010week group; for treatment\u2010experienced patients with cirrhosis, these values were 87% (26 of 30), 88% (14 of 16; 93% observed), and 86% (12 of 14), respectively. One patient (12\u2010week group) did not enter post\u2010treatment follow\u2010up (death unrelated to treatment). There were 4 relapses (2 per group) and no virological breakthroughs. The most common adverse events (AEs) were insomnia, fatigue, and headache. There were no discontinuations for AEs and no treatment\u2010related serious AEs. <jats:italic toggle=\"yes\">Conclusion<\/jats:italic>: The all\u2010oral regimen of DCV\u2010SOF\u2010RBV was well tolerated and resulted in high and similar SVR12 after 12 or 16 weeks of treatment among genotype 3\u2010infected patients with advanced liver disease, irrespective of past HCV treatment experience. (H<jats:sc>epatology<\/jats:sc> 2016;63:1430\u20101441)<\/jats:p>","DOI":"10.1002\/hep.28473","type":"journal-article","created":{"date-parts":[[2016,1,29]],"date-time":"2016-01-29T03:34:12Z","timestamp":1454038452000},"page":"1430-1441","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":225,"title":["Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized phase III study (ALLY\u20103+)"],"prefix":"10.1097","volume":"63","author":[{"given":"Vincent","family":"Leroy","sequence":"first","affiliation":[{"name":"Clinique Universitaire d'Hepato\u2010Gastroent\u00e9rologie, P\u00f4le Digidune,CHU de Grenoble and Unit\u00e9 INSERM\/Universit\u00e9 Grenoble Alpes U823, IAPC Institut Albert Bonniot,Grenoble,France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Angus","sequence":"additional","affiliation":[{"name":"Austin Hospital,Heidelberg,Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Pierre","family":"Bronowicki","sequence":"additional","affiliation":[{"name":"INSERM U954, CHU de Nancy,Universit\u00e9 de Lorraine,Nancy,France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory J.","family":"Dore","sequence":"additional","affiliation":[{"name":"St. Vincent's Hospital and Kirby Institute,UNSW Australia,Sydney,Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christophe","family":"Hezode","sequence":"additional","affiliation":[{"name":"CHU Henri Mondor,Cr\u00e9teil,France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Pianko","sequence":"additional","affiliation":[{"name":"Monash Medical Centre,Clayton,Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stanislas","family":"Pol","sequence":"additional","affiliation":[{"name":"H\u00f4pital Cochin,Paris,France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine","family":"Stuart","sequence":"additional","affiliation":[{"name":"Gallipoli Medical Research Foundation,Greenslopes,Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edmund","family":"Tse","sequence":"additional","affiliation":[{"name":"South Australia Health,Adelaide,Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fiona","family":"McPhee","sequence":"additional","affiliation":[{"name":"Bristol\u2010Myers Squibb Research & Development,Wallingford,CT"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rafia","family":"Bhore","sequence":"additional","affiliation":[{"name":"Bristol\u2010Myers Squibb Research & Development,Princeton,NJ"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Jesus","family":"Jimenez\u2010Exposito","sequence":"additional","affiliation":[{"name":"Bristol\u2010Myers Squibb Research & 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