Definitions of biochemical response and endpoints
ascites, death, cirrhosis-related, cirrhosis, cirrhosis-related complications, variceal bleeding
ASCITES, CIRRHOSIS, COMPLICATION, HEPATIC ENCEPHALOPATHY, EVENTS, COMPLICATIONS
The biochemical response to UDCA treatment was evaluated according to six previously published definitions: (1) Barcelona criteria, a decrease in ALP level 40% of baseline values or a return to normal levels after 1 year of treatment; (2) Paris-I criteria, biochemical response was defined as ALP < 3 × ULN, AST < 2 × ULN, and bilirubin ≤ 1 mg/dL after 1 year of UDCA treatment; (3) Paris-II criteria, AST and ALP ≤ 1.5 × ULN, with a normal bilirubin level after 1 year of UDCA therapy; (4) Rochester-II criteria, ALP < 2 × ULN at 12 months of UDCA therapy; (5) Rotterdam criteria, normalization of abnormal albumin and/or bilirubin levels after 1 year of UDCA treatment; (6) Ehime criteria, a 70% decrease from baseline level or a normal level of GGT after 6 months of UDCA treatment.For the present study, all the definitions mentioned above were applied and evaluated using the same endpoint, that is, the occurrence of adverse outcome as defined by at least one of the following events: liver-related death, liver transplantation, and complications of cirrhosis (namely ascites, variceal bleeding, or hepatic encephalopathy). Data were censored at the time of death or liver transplantation for the patient who died or underwent transplantation, and at the time of presenting with a cirrhosis-related complication or the last follow-up for the living non-transplanted patients. If a living non-transplanted patient developed more than one cirrhosis-related complication during follow-up, data were censored at the time of the first presentation of cirrhosis-related complications. To improve the prognostic performance of the criteria as early as possible, different cut-off values of ALP and AST levels with a normal TBIL at 1, 3, or 6 months were assessed to define new criteria.