Long-term Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Treatment

  • STATUS
    Recruiting
  • End date
    Sep 22, 2022
  • participants needed
    200
  • sponsor
    Kaohsiung Medical University Chung-Ho Memorial Hospital
Updated on 22 October 2021
carcinoma
hepatitis
interferon
ribavirin
hepatocellular carcinoma
fibrosis

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.

Description

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.

Details
Condition Metabolic disorder, Diabetes Mellitus, Adenocarcinoma, Cirrhosis, HEPATIC NEOPLASM, Cryoglobulinemia, HEPATOCELLULAR CARCINOMA, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Hepatic Fibrosis, Liver Cancer, Malignant Adenoma, Metabolic Disorders, liver fibrosis, diabetes mellitus (dm), metabolic diseases, metabolic disease, metabolism disorders, liver cell carcinoma
Treatment Observation only
Clinical Study IdentifierNCT03042520
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital
Last Modified on22 October 2021

Eligibility

Yes No Not Sure

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

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
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