PegIFN Alfa-2a and RBV for 16 or 24 Weeks in Patients With Chronic Hepatitis C(CHC) 2 With Rapid Virologic Response(RVR)
PegIFN Alfa-2a and RBV for 16 or 24 Weeks in Patients With Chronic Hepatitis C(CHC) 2 With Rapid Virologic Response(RVR)
This study aim to evaluate the non-inferiority of sustained virologic response in
 peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment
 duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.
In recent study (the ACCELERATE trial), treatment with peginterferon alfa-2a and ribavirin
 (800mg/day) for 16 weeks in patients infected with HCV genotype 2 or 3 result in a lower
 overall sustained virologic response rate than treatment with the standard 24 weeks regimen.
 Ribavirin was used as a flat dose (800mg/day) in ACCELERATE trial. But, previous studies
 which used the weight-based dose of ribavirin (800-1400mg/day) had shown that a treatment
 duration of 16 weeks was as effective as 24 weeks regimen in HCV genotype 2 patients with a
 RVR. But, there was too small number of patient enrolled study to argue logically about
 ACCELERATE trial. In this study, we aimed to confirm the non-inferiority peginterferon
 alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of
 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.
Inclusion Criteria:

 1. Age older than 18 years old

 2. Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test

 3. Detectable serum quantitative HCV-RNA

 4. HCV genotype 2 (VERSANT HCV Genotype Assay (LIPA))

 5. Patients have never been treated with traditional interferon plus ribavirin or
 peginterferon plus ribavirin

 Exclusion Criteria:

 1. Co-infection with hepatitis B and/or human immunodeficiency virus (HIV)

 2. History or other evidence of a medical condition associated with chronic liver disease
 other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease,
 alcoholic liver disease, toxin exposures)

 3. Decompensated liver disease (Child-Pugh class B or C)

 4. Neoplastic disease within 5 years

 5. Evidence of drug abuse (including excessive alcohol consumption) within one year of
 study entry

 6. Women with ongoing pregnancy or breast feeding

 7. Hgb < 11 g/dL in women or < 12 g/dL in men at screening

 8. Neutrophil count < 1500 cells/mm3 or platelet count < 90,000 cells/mm3 at screening

 9. Serum creatinine level > 1.5 times the upper limit of normal at screening

 10. Serum alpha-fetoprotein > 100 ng/mL

 11. History of severe psychiatric disease, especially depression. Severe psychiatric
 disease is defined as treatment with an antidepressant medication or a major
 tranquilizer at therapeutic doses for major depression or psychosis, respectively, for
 at least 3 months at any previous time or any history of the following: a suicidal
 attempt, hospitalization for psychiatric disease, or a period of disability due to a
 psychiatric disease

 12. History of immunologically mediated disease, chronic pulmonary disease associated with
 functional limitation, severe cardiac disease, major organ transplantation or other
 evidence of severe illness, malignancy, or any other conditions which would make the
 patient, in the opinion of the investigator, unsuitable for the study

 13. History or other evidence of bleeding from esophageal varices or other conditions
 consistent with decompensated liver disease

 14. History of a severe seizure disorder or current anticonvulsant use

 15. Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)

 16. Inability or unwillingness to provide informed consent or abide by the requirements of
 the study