Efficacy and Effectiveness of PegInterferon and Ribavirin in Korean Patients With Chronic Hepatitis C

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy and effectiveness of peginterferon alfa-2a and ribavirin therapy in Korean chronic hepatitis C patients.

Detailed Description
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A retrospective analysis of a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial of combination of peginterferon alfa-2a and ribavirin (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004 and a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008

Official Title
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Efficacy and Effectiveness of Combination Therapy With Pegylated Interferon Alfa-2a and Ribavirin in Korean Patients With Chronic Hepatitis C

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 1
* Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all of below adults aged 18-70 years serum anti-HCV antibody (+) HCV RNA detectable by PCR compensated liver disease (Child-Pugh class A) Exclusion Criteria: any of below HCV genotype other than 1, 2, or 3 acute hepatitis C decompensated cirrhosis or hepatocellular carcinoma other liver disease such as hepatitis A or B, or autoimmune hepatitis HIV Ab(+) severe depression or other psychiatric disease previous organ transplantation absolute neutrophil count (ANC) < 1,000 cells/mm3 or platelet count < 75,000 cells/mm3, or hemoglobin (Hb) < 13 g/dL for men, <12 g/dL for women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Korean CHC<br>Two CHC patient groups. One is CHC patients who are treated with combination of peginterferon alfa-2a and ribavirin in a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004. Another is a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008. | Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 1<br>* Patients with genotype 1: treatment with peginterferon α-2a (Roche, Basel, Switzerland) 180 μg/week and daily ribavirin dose of 1,000 mg (for patients with body weight <75kg) or 1,200 mg (for patients with body weight ≥75kg) for 48 weeks.<br>* Other names: Copegus;Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3<br>* Patients with genotype 2 or 3: treatment with peginterferon α-2a 180 μg/week and daily ribavirin dose of 800 mg for 24 weeks.<br>* Other names: Copegus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients achieving sustained virological response (SVR) | SVR is defined as a documented undetectable serum HCV RNA by PCR at 24 weeks after cessation of treatment | at 24 weeks after cessation of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients achieving early virological response (EVR) | EVR is defined as reduction of HCV RNA level by 2 log or more at 12 weeks of treatment | at 12 weeks of treatment | 
| the proportion of patients achieving complete EVR (cEVR) | cEVR is defined as HCV RNA undetectable by PCR at 12 weeks of treatment | at 12 weeks of treatment | 
| The proportion of patients achieving end-of-treatment response (ETR) | ETR is defined as HCV RNA undetectable at the end of treatment. | at week 48 for HCV genotype 1 and at week 24 for HCV genotype 2/3 |