long-term outcomes of chronic hepatitis c patients post sofosbuvir-based treatment

Conditions: Liver Fibroses; HepatoCellular Carcinoma; Cryoglobulinemia; Metabolic Disease; Diabetes Mellitus

Summary: primary objective: to evaluate the long-term outcomes including liver related morbidity, mortality and hepatocellular carcinoma (hcc) development as compared to those of historical control with interferon(ifn)-based treatment. secondary objective: 1. to access liver fibrosis progression/regression in chc patients after sofosbuvir-based treatment. 2. to investigate the long-term outcomes of extrahepatic manifestations of the sofosbuvir-based treated cohort as compared to their pretreatment status.

primary endpoint: to evaluate the long-term event-free effect after sofosbuvir-based therapy, in terms of free of major liver events (including hcc, decompensation with ascites, variceal bleeding, hepatic encephalopathy, and liver-related mortality) in chc patients. secondary endpoints: 1. to evaluate hepatic fibrosis progression or regression in chc patients after sofosbuvir-based therapy. 2. to evaluate the durability of sustained viral response (svr) in patients achieving svr after sofosbuvir-based therapy. 3. to evaluate long-term effect of sofosbuvir-based therapy on the extra-hepatic manifestations of the cohort. the items include mixed cryoglobulinemia, chronic kidney diseases, insulin resistance, diabetic status, cardiovascular events and dyslipidemia. 4. to evaluate long-term effect of sofosbuvir-based therapy on quality of life on the cohort. study design prospective, longitudinal observational study study procedure a total of 200 patients receiving sofosbuvir based direct antiviral agents (daas) in the parent studies will be included for following up to 5 years. their serological, image study and disease status description will be prospectively documented to present the long term effects of sofosbuvir-based therapy. the presentation of illness will be specified as: 1. main hepatic complications as liver fibrosis, hepatic malignancy, liver decompensation with ascites, hepatic encephalopathy and variceal bleeding, and liver-related mortality. 2. life quality, extrahepatic symptoms as cryoglobulinemia, diabetes mellitus, insulin resistance, lipid profiles, renal insufficiency and other non-liver morbidities and malignancy.

Eligibility criteria:
main inclusion criteria: for sofosbuvir-based therapy observational group: * patients ≥ 20 of years who had ever participated in parent studies, gs-us-337-0131 (nct02021656) or gs-us-334-0115 (nct02021643) * patients who had received at least one dose of sofosbuvir-based therapy in the parent studies. who ifn-based therapy historical controls, matched with sex, age, level of liver fibrosis and virological response: * patients ≥ 20 of years who had received pegylated interferon plus ribavirin therapy with match of sex, age, level of liver fibrosis and virological response * patients who have ever participated study will be collected as historical control. main exclusion criteria: * patients not qualified by the main inclusion criteria were excluded. for sofosbuvir-based therapy observational group: * patients \< 20 of years * patients who are unwilling to participate the current study * patients who had never participated in parent studies, gs-us-337-0131 (nct02021656) nor gs-us-334-0115 (nct02021643) * patients who had never received at least one dose of sofosbuvir-based therapy in the parent studies. who ifn-based therapy historical controls: * patients \< 20 of years * patients who are unwilling to participate the current study * patients who had never received pegylated interferon plus ribavirin therapy * patients who did not participate study