Chronic hepatitis C
Conditions
Interventions
Telaprevir (TVR) based triple therapy combined with pegylated-IFN-alpha (PEG-IFN-alpha) and ribavirin (RBV)
Dual therapy of PEG-IFN-alpha and RBV
Sponsors
Department of General Internal Medicine, Kyushu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient inclusion criteria for the study required patients to be infected with HCV genotype 1 and baseline serum HCV RNA positive (>5.0 log10 IU/mL).
Exclusion criteria
Exclusion criteria: The exclusion criteria were as follows: (1) presence of HCC at enrollment, or development of HCC until 24 weeks after EOT; (2) shortening of treatment due to adverse effect, virological breakthrough, non-virological response (NVR), or dropout; (3) in dual therapy group, extension of standard 48-week therapy; (4) inadequate treatment dose of 80% or less assigned total cumulative dosage of each drug; (5) positivity for antibody to human immunodeficiency virus or positivity for hepatitis B surface antigen; (6) clinical or biochemical evidence of hepatic decompensation (Child-Pugh B or C, ascites, bleeding varices, or encephalopathy) at enrollment; (7) excessive active alcohol consumption (a daily intake of more than 60g of alcohol) or drug abuse; (8) other forms of liver disease (e.g., autoimmune hepatitis, alcoholic liver disease, hemochromatosis); or (9) treatment with antiviral or immunosuppressive agents prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decline of the AFP level by treatment | — |
Countries
Japan
Contacts
Public ContactNorihiro Furusyo, MD.
Kyushu University Hospital Department of General Internal Medicine
Outcome results
None listed