PegIFN Alfa-2a and RBV for 16 or 24 Weeks in Patients With Chronic Hepatitis C(CHC) 2 With Rapid Virologic Response(RVR)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Randomized, Open Labeled, Phase IV, Multicenter Study for Peginterferon Alfa-2a and Weight-based Ribavirin for 16 or 24 Weeks in genotype2 Chronic Hepatitis C Patients Who Achieved Rapid Virologic Response

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Peginterferon alfa-2a and Ribavirin
* Drug: Peginterferon alfa-2a and Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age older than 18 years old Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test Detectable serum quantitative HCV-RNA HCV genotype 2 (VERSANT HCV Genotype Assay (LIPA)) Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin Exclusion Criteria: Co-infection with hepatitis B and/or human immunodeficiency virus (HIV) 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) Decompensated liver disease (Child-Pugh class B or C) Neoplastic disease within 5 years Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry Women with ongoing pregnancy or breast feeding Hgb < 11 g/dL in women or < 12 g/dL in men at screening Neutrophil count < 1500 cells/mm3 or platelet count < 90,000 cells/mm3 at screening Serum creatinine level > 1.5 times the upper limit of normal at screening Serum alpha-fetoprotein > 100 ng/mL 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 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 History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease History of a severe seizure disorder or current anticonvulsant use Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) Inability or unwillingness to provide informed consent or abide by the requirements of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A. 24 weeks in RVR patients.<br>Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 24 weeks in patients with RVR. | Drug: Peginterferon alfa-2a and Ribavirin<br>* PegIFN alfa-2a (PEgasys) 180 ug/week Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day) Treatment duration: 24 weeks<br>|
| Experimental: B. 16 weeks in RVR patients.<br>Peginterferon alfa-2a and weight-based ribavirin (800-1200mg/day) for 16 weeks in patients with RVR. | Drug: Peginterferon alfa-2a and Ribavirin<br>* PegIFN alfa-2a (PEgasys) 180 ug/week Weight-based ribavirin (<65kg: 800mg/day, 65-85kg: 1000mg/day, >85kg: 1200mg/day) Treatment duration: 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virologic response (SVR) |  | 24 weeks post-treatment (week 40 or week 48) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs | 16 weeks treatment arm: 40 weeks 24 weeks treatment arm: 48 weeks | up to 24 weeks after last treatment visit | 
| laboratory parameters | 16 weeks treatment arm: 40 weeks 24 weeks treatment arm: 48 weeks | up to 24 weeks after last treatment visit | 
| vital signs | 16 weeks treatment arm: 40 weeks 24 weeks treatment arm: 48 weeks | up to 24 weeks after last treatment visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis C, Genotype 2, Rapid virologic response, Sustained virologic response, Peginterferon alfa-2a, Ribavirin