Patients with chronic hepatitis C virus infection
Conditions
Interventions
Simeprevir with pegylated interferon alfa and low dose of ribavirin Simeprevir: 100mg/day, orally, 12 weeks Pegylated interferon: alfa-2a 180mcg/week, alfa-2b 1.5mcg/kg/week, subcutaneous infusio
Sponsors
Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with 20 years of age and older 2) Naive patients with HCV egnotype 1 with viral load of more than 5 log IU/ml 3) Treatment-experienced patients with HCV egnotype 1 4) Patients with less than 12 g/dl of hemoglobin 5) Eligible patients for interferon and ribavirin 1) Co-infection with hepatitis B virus 2) Co-infection with anti-human immunodeficiency virus 3) Other forms of liver disease (alcohol liver disease, autoimmune hepatitis etc.) 4) Decompensated cirrhosis, Liver failure 5) Severe multisystem disease, Severe immunodeficiency 6) Contraindication to pegylated interferon 7) Contraindication to ribabirin
Exclusion criteria
Exclusion criteria: 1) Co-infection with hepatitis B virus 2) Co-infection with anti-human immunodeficiency virus 3) Other forms of liver disease (alcohol liver disease, autoimmune hepatitis etc.) 4) Decompensated cirrhosis, Liver failure 5) Severe multisystem disease, Severe immunodeficiency 6) Contraindication to pegylated interferon 7) Contraindication to ribabirin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virologic response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| The factor associated with sustained virologic response Safety Emergence of drug-resistant virus Cumulative incidence of hepatocellular carcinoma The factor associated with incidence of hepatocellular carcinoma | — |
Countries
Japan
Contacts
Public ContactRyotaro Sakamori
Osaka University Graduate School of Medicine Gastroenterology and Hepatology
Outcome results
None listed