Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication

Study Overview
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Brief Summary
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Open-label, single centre study evaluating efficacy and viral kinetics of combination PEG-IFNa2a and Ribavirin treatment on CHC genotype 1 patients, administered until viral clearance demonstrated between 4 - 12 weeks, then randomised to further continued combination treatment for one of three defined durations. Followed-up for 24 weeks after treatment cessation. Objectives: To determine the necessary duration of combination treatment with Pegylated-Interferon alfa2a (PEGASYS) & Ribavirin in Patients infected with genotype 1, in order to achieve viral clearance To identify host factors, which are associated with different patterns of virological response to combination treatment (fast responder, slow responder, non-responder). On this basis, to identify possible predictors for the duration of antiviral treatment.

Detailed Description
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Forty treatment-naïve patients with chronic hepatitis C, all infected with genotype 1, will be entered into this study. All 40 patients will be started on the same regimen of 180mg Pegylated-Interferon alfa2a (PEGASYS) weekly plus Ribavirin 1000-1200mg daily. HCV RNA in the serum will be monitored by qualitative PCR at treatment weeks 4, 8 and 12. Patients who become HCV RNA negative at any of the above time-points (4,8 or 12), will be randomised into one of three groups to continue the same antiviral regimen for an additional 3 month, 6 month or 9 month period. All these patients will subsequently be followed-up and monitored for a further 6 months after stopping all antiviral treatment. Treatment will be discontinued for patients who remain persistently HCV RNA positive at treatment week 12 and they will be withdrawn from the study protocol.

Official Title
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Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication

Conditions
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Chronic Hepatitis C, HCV Genotype 1

Intervention / Treatment
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* Drug: Pegylated interferon-alfa2a (Pegasys); ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 65 HCV RNA positive HCV genotype 1 Histologically proven chronic hepatitis No previous antiviral treatment Exclusion Criteria: Liver histology showing cirrhosis Decompensated liver function WCC < 1500/mm3 or platelet count <90,000/mm3 Co-infection with HIV or HBV/HAV Alcohol intake greater than 40 units/week Current intravenous drug dependence Pregnancy or breast feeding of infants Inadequate contraception Neuropsychiatric disorder Neoplastic disease Other significant medical problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Drug: Pegylated interferon-alfa2a (Pegasys); ribavirin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response (HCV RNA negative) 6 months post-treatment cessation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic and serum HCV RNA levels as a predictor for treatment duration |  |  | 
| HCV-specific T-cell reactivity as a predictor for treatment duration |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, genotype 1, treatment, HCV kinetics, T-cells