• Jordan J Feld, Christophe Moreno, Roger Trinh, Edward Tam, Stefan Bourgeois, Yves Horsmans, Magdy Elkhashab, David E Bernstein, Ziad Younes, Robert W Reindollar, Lois Larsen, Bo Fu, Kevin Howieson, Akshanth R Polepally, Andreas Pangerl, Nancy S Shulman, and Fred Poordad.
• Toronto Centre for Liver Disease, University of Toronto, Toronto, ON, Canada. Electronic address: jordan.feld@uhn.ca.
• J. Hepatol. 2016 Feb 1; 64 (2): 301-307.

Background & AimsPatients with chronic hepatitis C virus (HCV) infection and cirrhosis have a higher risk for liver-related complications and have historically been more difficult to cure than patients without cirrhosis. We evaluated the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir, without ribavirin, for 12weeks in patients with HCV genotype 1b infection and compensated cirrhosis.MethodsTreatment-naïve and peginterferon/ribavirin treatment-experienced patients received 12weeks of ombitasvir/paritaprevir/ritonavir (25/150/100mg once daily) and dasabuvir (250mgtwicedaily). Key inclusion criteria were hemoglobin ⩾10g/dl, albumin ⩾2.8g/dl, platelet count ⩾25×10(9)/L, creatinine clearance ⩾30ml/min, and Child-Pugh score ⩽6. Efficacy was assessed by the percentage of patients achieving SVR (HCV RNA <25IU/ml) 12weeks post-treatment (SVR12). Efficacy and safety were assessed in all patients receiving study drug.ResultsSixty patients with HCV genotype 1b infection and cirrhosis received treatment. The study population comprised 62% male, 55% treatment-experienced, 83% with IL28B non-CC genotype, 22% with platelet count <90×10(9)/L, and 17% with albumin <3.5g/dl. All 60 patients completed treatment, and SVR12 was achieved in 100% (95% CI, 94.0-100%) of patients. The most common adverse events were fatigue (22%), diarrhea (20%), and headache (18%). Only one patient (1.7%) experienced a serious adverse event. Laboratory abnormalities were infrequently observed and not clinically significant.ConclusionsThe HCV regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir without ribavirin for 12weeks achieved 100% SVR12 and was well tolerated in HCV genotype 1b-infected patients with cirrhosis, suggesting that this 12-week ribavirin-free regimen is sufficient in this population.Copyright © 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

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