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Sustained virological response (<jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>) was assessed in individual phase 3 studies; a pooled analysis was carried out for safety outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the Japanese phase 3 study, <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 was achieved by 91% of patients with cirrhosis (<jats:italic>n<\/jats:italic> = 22) and 84% of patients without cirrhosis (<jats:italic>n<\/jats:italic> = 200); in the global phase 3 study, <jats:styled-content style=\"fixed-case\">SVR<\/jats:styled-content>12 was achieved by 84% of patients with cirrhosis (<jats:italic>n<\/jats:italic> = 206) and by 85% of patients without cirrhosis (<jats:italic>n<\/jats:italic> = 437). The frequency of serious adverse events, adverse events leading to treatment discontinuation and treatment\u2010emergent grade 3\/4 laboratory abnormalities was low (&lt;10%) and similar among patients with (<jats:italic>n<\/jats:italic> = 229) or without (<jats:italic>n<\/jats:italic> = 689) compensated cirrhosis receiving <jats:styled-content style=\"fixed-case\">DCV<\/jats:styled-content>+<jats:styled-content style=\"fixed-case\">ASV<\/jats:styled-content>. Grade 3\/4 reductions in platelets and neutrophils were more common among patients with cirrhosis (1.3 and 2.2%, respectively) compared with those without cirrhosis (both 0.6%). Grade 3\/4 liver function test abnormalities were less common among patients with cirrhosis (1.8%) compared with those without cirrhosis (3.5\u20134.7%). Alanine aminotransferase elevations were not associated with hepatic decompensation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The safety and efficacy of <jats:styled-content style=\"fixed-case\">DCV<\/jats:styled-content>+<jats:styled-content style=\"fixed-case\">ASV<\/jats:styled-content> were similar in patients with or without compensated cirrhosis. This all\u2010oral, interferon\u2010 and ribavirin\u2010free combination is an effective and well\u2010tolerated treatment option for patients with <jats:styled-content style=\"fixed-case\">HCV GT<\/jats:styled-content>1b infection and cirrhosis.<\/jats:p><jats:p>Trial registrations numbers: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/Clinicaltrials.gov\">Clinicaltrials.gov<\/jats:ext-link> identifiers: NCT01012895; NCT01051414; NCT01581203; NCT01497834.<\/jats:p><\/jats:sec>","DOI":"10.1111\/liv.13049","type":"journal-article","created":{"date-parts":[[2015,12,19]],"date-time":"2015-12-19T02:44:56Z","timestamp":1450493096000},"page":"954-962","source":"Crossref","is-referenced-by-count":13,"title":["Daclatasvir plus asunaprevir for <scp>HCV<\/scp> genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis"],"prefix":"10.1111","volume":"36","author":[{"given":"Jia\u2010Horng","family":"Kao","sequence":"first","affiliation":[{"name":"Graduate Institute of Clinical Medicine National Taiwan University College of Medicine and Hepatitis Research Center National Taiwan University Hospital Taipei Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donald M.","family":"Jensen","sequence":"additional","affiliation":[{"name":"Center for Liver Diseases University of Chicago Medical Center Chicago IL USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael P.","family":"Manns","sequence":"additional","affiliation":[{"name":"Hannover Medical School Hannover Germany"},{"name":"German Center for Infection Research Hannover\u2010Braunschweig Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ira","family":"Jacobson","sequence":"additional","affiliation":[{"name":"Department of Medicine at Mount Sinai Beth Israel Medical Center New York NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiromitsu","family":"Kumada","sequence":"additional","affiliation":[{"name":"Toranomon Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joji","family":"Toyota","sequence":"additional","affiliation":[{"name":"Sapporo\u2010Kosei General Hospital Sapporo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeong","family":"Heo","sequence":"additional","affiliation":[{"name":"College of Medicine Pusan National University and Medical Research Institute Pusan National University Hospital Busan South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Boris","family":"Yoffe","sequence":"additional","affiliation":[{"name":"Veterans Affairs Medical Center Baylor College of Medicine Houston TX USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William","family":"Sievert","sequence":"additional","affiliation":[{"name":"Monash Health and Monash University Melbourne Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fernando","family":"Bessone","sequence":"additional","affiliation":[{"name":"Hospital Provincial del Centenario Servicio de Gastroenterolog\u00eda y Hepatolog\u00eda Universidad Nacional de Rosario Rosario Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cheng\u2010Yuan","family":"Peng","sequence":"additional","affiliation":[{"name":"School of Medicine China Medical University Taichung Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stuart K.","family":"Roberts","sequence":"additional","affiliation":[{"name":"Alfred Hospital and Monash University Melbourne Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Youn\u2010Jae","family":"Lee","sequence":"additional","affiliation":[{"name":"Inje University Busan Paik Hospital Busan South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rafia","family":"Bhore","sequence":"additional","affiliation":[{"name":"Bristol\u2010Myers Squibb Research and Development Princeton NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia","family":"Mendez","sequence":"additional","affiliation":[{"name":"Bristol\u2010Myers Squibb Research and Development Princeton NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Hughes","sequence":"additional","affiliation":[{"name":"Bristol\u2010Myers Squibb Research and Development Princeton NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie","family":"Noviello","sequence":"additional","affiliation":[{"name":"Bristol\u2010Myers Squibb Research and Development Princeton NJ USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,1,24]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2014.07.027"},{"key":"e_1_2_8_3_1","unstructured":"World Health Organization.Hepatitis C Key Facts. 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