JIA-HORNG KAOJensen D.M.Manns M.P.Jacobson I.Kumada H.Toyota J.Heo J.Yoffe B.Sievert W.Bessone F.Peng C.-Y.Roberts S.K.Lee Y.-J.Bhore R.Mendez P.Hughes E.Noviello S.2021-09-042021-09-0420161478-3223https://www.scopus.com/inward/record.uri?eid=2-s2.0-84979502248&doi=10.1111%2fliv.13049&partnerID=40&md5=78c7cc817f497a024d979c2bfbbb28f6https://scholars.lib.ntu.edu.tw/handle/123456789/581911Background & Aims: We compared outcomes by cirrhosis status across studies of the all-oral combination of daclatasvir (DCV) plus asunaprevir (ASV). Methods: Outcomes from global and Japanese phase 2 and 3 clinical studies of DCV+ASV in patients with genotype (GT) 1b infection were assessed by cirrhosis status. Sustained virological response (SVR) was assessed in individual phase 3 studies; a pooled analysis was carried out for safety outcomes. Results: In the Japanese phase 3 study, SVR12 was achieved by 91% of patients with cirrhosis (n = 22) and 84% of patients without cirrhosis (n = 200); in the global phase 3 study, SVR12 was achieved by 84% of patients with cirrhosis (n = 206) and by 85% of patients without cirrhosis (n = 437). The frequency of serious adverse events, adverse events leading to treatment discontinuation and treatment-emergent grade 3/4 laboratory abnormalities was low (<10%) and similar among patients with (n = 229) or without (n = 689) compensated cirrhosis receiving DCV+ASV. 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 (3.5–4.7%). Alanine aminotransferase elevations were not associated with hepatic decompensation. Conclusions: The safety and efficacy of DCV+ASV were similar in patients with or without compensated cirrhosis. This all-oral, interferon- and ribavirin-free combination is an effective and well-tolerated treatment option for patients with HCV GT1b infection and cirrhosis. Trial registrations numbers: Clinicaltrials.gov identifiers: NCT01012895; NCT01051414; NCT01581203; NCT01497834. ? 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltdcirrhosis; direct acting antiviral; hepatitis C; safety[SDGs]SDG3alanine aminotransferase; aspartate aminotransferase; asunaprevir; bilirubin; creatinine; daclatasvir; triacylglycerol lipase; abnormal laboratory result; adult; alanine aminotransferase blood level; antiviral therapy; Article; ascites; aspartate aminotransferase blood level; bilirubin blood level; clinical effectiveness; compensated liver cirrhosis; creatinine blood level; diarrhea; esophagus varices bleeding; fatigue; female; headache; hepatitis C; hepatitis C virus genotype 1b infection; hepatitis C virus genotype 1b infection; Hepatitis C virus subtype 1b; human; liver cell carcinoma; lymphocyte count; major clinical study; male; nausea; neutrophil count; outcome assessment; patient safety; phase 3 clinical trial; rhinopharyngitis; side effect; thrombocyte count; triacylglycerol lipase blood leveljournal article10.1111/liv.13049266837632-s2.0-84979502248