Chronic hepatitis C genotype 2 and 3 Digestive System Chronic hepatitis, not elsewhere classified
Conditions
Interventions
Patients fulfilling the selection criteria received in an open-label fashion pegylated interferon alfa-2a at a dose of 180 µg subcutaneously once weekly and oral ribavirin, at a dosage of 1000 mg/day
Sponsors
Club Hepatology Hospital (Club Epatologi Ospedalieri [CLEO]) Group (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HCV ribonucleic acid (RNA) positive 2. HCV genotype 2 or 3 3. Elevated alanine aminotransferase (greater than 40 IU/L) at least 8 months prior to study entry 4. Histologically proven chronic HCV hepatitis 5. Naive to treatment 6. Aged 20 - 68 years, either sex
Exclusion criteria
Exclusion criteria: 1. Known to have injected drugs or alcohol abuse (greater than 40 g ethanol/day) within the 6 months prior to study entry 2. Poorly controlled psychiatric illness 3. Decompensated cirrhosis 4. Positive for human immunodeficiency antibody virus or positive for hepatitis B surface antigen 5. Pregnancy, lactation 6. Impaired renal function 7. Other concurrent medical conditions of the liver different from HCV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained virological response (SVR) which was defined as undetectable plasma HCVRNA (less than 50 IU/ml) 24 weeks after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Virological response rates (HCVRNA negative in serum with a detection limit of 50 IU/ml) at the end of therapy 2. Severity and frequency of adverse events | — |
Countries
Italy
Outcome results
None listed