Patients with chronic HCV infection, who failed to DCV/ASV therapy
Conditions
Interventions
RBV add-on for 12 weeks
Sponsors
Hokkaido University Department of Gastroenterology and Hepatology, Graduate School of Medicine,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients (1) with the target disease who (2) satisfy all the inclusion criteria and (3) meet none of the exclusion criteria are eligible for the study. (1) Subjects Patients with a chronic HCV infection and compensated cirrhosis who failed to DCV/ASV combination therapy (2) Inclusion criteria [1] Patients who are 20 years of age or older at the time of informed consent [2] Patients who have been fully informed and have provided written informed consent to participate in this study prior to study initiation [3] Patients with a chronic HCV genotype 2 infection and compensated cirrhosis who do not meet any of the following exclusion criteria
Exclusion criteria
Exclusion criteria: 1) Patients with poorly controlled cardiac disease (e.g., myocardial infarction, cardiac failure, arrhythmia) 2) Patients with severe hepatic impairment 3) Patients with a history of hypersensitivity to HCV NS5B inhibitors, Ribavirin and NS5A inhibitors 4) Patients with a concurrent malignancy, including hepatocellular carcinoma, at the start of treatment 5) Patients deemed unsuitable for study entry by their treating physician 6) Patients with renal dysfunction eGFR 50 ml/min 7) Patients who are unsuitable, in the opinion of the principal investigator, for this study due to any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the sustained virologic response (SVR) rate at follow-up Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Effects of HCV NS5A/B mutations as viral factors on virologic response 2) Rate of emergence of drug-resistant variants 3) Presence or absence of a reversal of liver fibrosis 4) Presence or absence of an improvement in AFP levels 5) Incidence of AEs | — |
Countries
Japan
Contacts
Public ContactGoki Suda
Hokkaido University Department of Gastroenterology and Hepatology, Graduate School of Medicine,
Outcome results
None listed