PEG-IFN Plus Ribavirin Combination Therapy for Older Patients

Study Overview
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Brief Summary
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The purpose of this study is to analyze the efficacy and safety of a combination therapy of pegylated interferon (PEG-IFN) alpha-2b plus ribavirin (RBV) for older Japanese patients (≧65years old) infected with hepatitis C virus (HCV) compared with younger patients(< 65 years old).

Official Title
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Pegylated Interferon Alpha-2b Plus Ribavirin Combination Treatment for Older Patients With Chronic Hepatitis C

Conditions
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Hepatitis C Virus

Intervention / Treatment
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* Drug: Pegylated interferon alpha-2b plus ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A prospective study of 2270 Japanese patients aged 18 years or older treated with PEG-IFN alpha-2b plus RBV was done between December 2004 and July 2008. All positive for both antibody to HCV and HCV-RNA for over six months and were enrolled. Exclusion Criteria: Clinical or biochemical evidence of hepatic decompensation. Advanced cirrhosis identified by large esophageal varices (F2 or F3). History of gastrointestinal bleeding, ascites, encephalopathy, or hepatocellular carcinoma. Hemoglobin level < 11.5g/L, white blood cell count < 3×10９/Ｌ，and platelet count < 50×10９/Ｌ. Concomitant liver disease other than hepatitis C(hepatitis B surface antigen positive or HIV positive). Excessive active alcohol consumption > 60 g/day or drug abuse. Severe psychiatric disease. Antiviral or corticosteroid therapy within 12 months prior to the enrollment.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pegylated interferon alpha-2b plus ribavirin|All patients were treated with a weight-based, 1.5 μg/kg weekly dose of subcutaneous PEG-IFN alpha-2b (PegIntron A, Schering-Plough, Osaka, Japan), in combination with PEG-IFN alpha-2b, RBV (Rebetol; Schering-Plough), which was given orally at a daily dose of 600-1000mg based on bodyweight (600 mg for patients weighing < 60 kg, 800 mg for those weighing 60-80 kg, and 1000 mg for those weighing 80 kg). The length of treatment was 48 weeks for patients with HCV of genotype 1and 24 weeks for patients with genotypes 2, respectively|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antiviral effect by PEG-IFN alpha-2b plus RBV treatment |  | 24-weeks follow-up after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the tolerance of older patients by PEG-IFN alpha-2b plus RBV treatment |  | during PEG-IFN alpha-2b plus RBV treatment (48 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C Virus Pegylated Interferon Ribavirin Older