Long-term Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Treatment
- Conditions
- Diabetes MellitusLiver FibrosesHepatoCellular CarcinomaCryoglobulinemiaMetabolic Disease
- Interventions
- Other: Observation only
- Registration Number
- NCT03042520
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description IFN-based therapy historical controls Observation only Patients who had ever participated the parent studies, GS-US-334-0115 or GS-US-337-0131, will be invited to participate the current study in outpatient clinic. For the patients who have participated study will be invited to participate the current study as matched historical control n our outpatient clinic, Sofosbuvir-based therapy observational group Observation only 1. Patients ≥ 20 of years who had ever participated in parent studies, GS-US-337-0131 (NCT02021656) or GS-US-334-0115 (NCT02021643) 2. 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: 1. Patients ≥ 20 of years who had received peginterferon plus ribavirin therapy with match of sex, age, level of liver fibrosis and virological response 2. Patients who have ever participated study will be collected as historical control.
- Primary Outcome Measures
Name Time Method Number of participants with liver-related morbidity development during 5-year follow-up period after sofosbuvir-based treatment 6 years Number of participants with liver-related morbidity during 5-year follow-up period after sofosbuvir-based treatment, including liver fibrosis progression and decompensation
Number of participants with liver-related mortality development during 5-year follow-up period after sofosbuvir-based treatment 6 years Number of participants with liver-related mortality assessed by death due to HCC and/or liver decompensation
Number of participants with hepatocellular carcinoma (HCC) development during 5-year follow-up period after sofosbuvir-based treatment 6 years Number of participants with HCC assessed by histocytology or positive dynamic image plus alpha fetoprotein (AFP) \> 400 ng/ml
- Secondary Outcome Measures
Name Time Method Lipid profiles 6 years Change of the serum profile of lipids including triglyceride(TG), cholesterol(Chol), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) from baseline
Insulin resistance 6 years Change of homeostatic model assessment (HOMA-IR), assessed by Glucose x insulin/22.5 from baseline
Life quality 6 years The change of short form(SF)-36 from baseline
Cryoglobulinemia 6 years Change of proportion of participants with cryoglobulinemia from baseline cryoglobulinemia from baseline)
Diabetes mellitus (DM) 6 years Number of participants without DM develop DM assessed by Ac sugar \> 126 g/ml
Renal disease 6 years the change of the estimated glomerular filtration rate (eGFR) from baseline
Trial Locations
- Locations (26)
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Seoul National University Bundang Hosptial
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Changhua Christian Hospital
🇨🇳Changhua, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Asan Medical Center
🇰🇷Asan, Korea, Republic of
Gachon University Gil Hospital
🇰🇷Incheon, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon.
🇰🇷Bucheon, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kaoshiung Medical University Hospital
🇨🇳Kaohsiung City, Taiwan
Keelung Chang Gung Memorial Hospital
🇨🇳Keelung, Taiwan
China Medical University
🇨🇳Taichung, Taiwan
MacKay Memorial Hospital
🇨🇳Taipei, Taiwan
National Cheng Kung University Hospital
🇨🇳Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Chi Mei Liouying Hospital
🇨🇳Tainan, Taiwan