Clinical outcomes were predefined in the HALT-C Trial protocol and included death due to any cause, liver-related death, HCC, and hepatic decompensation (ascites, hepatic encephalopathy, variceal hemorrhage, or spontaneous bacterial peritonitis); we also collected data on liver transplantation. Two definitions

of HCC were adopted in the HALT-C Trial: “definite” HCC and “presumed” HCC. Definite HCC was defined by histologic confirmation or a new, ≥2-cm mass lesion on imaging with AFP levels increasing to >1000 ng/mL. Presumed HCC was defined as a new mass lesion on ultrasound in the absence of histology and AFP < 1000 ng/mL selleck in conjunction with one of the following characteristics: (1) two liver imaging studies showing a mass lesion with characteristics of HCC, (2) progressively enlarging lesion on ultrasound and leading to death, or (3) one additional imaging study showing a mass lesion with characteristics of HCC that either increased in size over time or was accompanied by increasing AFP levels.11 An outcome committee, whose

members consisted of a rotating panel of three clinical site investigators blinded to study participant and clinical site, reviewed and adjudicated the validity of each clinical outcome. For the current analysis, we assessed overall mortality (i.e., death from any cause) or liver transplantation, and liver-related morbidity and mortality. Death from any cause or liver transplantation was defined this website as any patient who died (of any cause) or had undergone liver transplantation. The four categories of liver-related morbidity and mortality were: (1) Any liver-related clinical outcome: all patients in whom decompensated liver disease (ascites, variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis) or HCC (presumed or definite) developed, or who had undergone liver transplantation, or died from conditions related to liver disease. For the calculation of

the cumulative selleck chemical incidence of any liver-related outcomes, patients were censored at the time when the first outcome developed. (2) Decompensated liver disease: all patients whose first clinical outcome was decompensated liver disease. (3) HCC: all patients in whom, at any time during the study, definite or presumed HCC developed. (4) Liver-related death or liver transplantation: any patient who died as the result of a liver-related cause, based on the opinion of the clinical site principal investigator, or who had undergone liver transplantation. Statistical analyses were performed at the Data Coordinating Center (New England Research Institute, Watertown, MA) with SAS software, release 9.1 (SAS Institute Inc., Cary, NC). The chi-squared and analysis of variance tests were used to determine categorical and continuous variables that were significantly different between the SVR group and the two comparison groups (NR and BT/R).