An Observational Study of Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) on Predictive Values of RVR on Sustained Virological Response in Different Stages of Liver Fibrosis in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1

Study Overview
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Brief Summary
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This observational study will evaluate the predictive value of rapid virological response (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will be followed for 48 weeks of treatment and up to 24 weeks of follow-up.

Official Title
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An Observational Study of Peginterferon-alfa-2a (Pegasys) and Ribavirin (Copegus) on Predictive Values of RVR on Sustained Virological Response (SVR) in Different Stage of Liver Fibrosis in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C

Conditions
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Hepatitis C, Chronic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >/= 18 years of age Chronic hepatitis C genotype 1 Treatment-naïve, i.e. have not been previously treated with pegylated interferon, standard interferon and ribavirin Confirmed serum positive HCV RNA Liver fibrosis confirmed histologically or by fibroscan up to 24 months before treatment Exclusion Criteria: Any contraindications according to the Summary of Product Characteristics for Pegasys or Copegus Co-infection with hepatitis B or HIV Post-transplant patients End stage renal disease (creatinine clearance < 15 ml/min) Patients treated with immunotherapy Pregnant women and male partners of women who are pregnant Female patients of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use effective and continuous contraception during the treatment and for 4 months (females) and 7 months (males) thereafter

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response (SVR) rate, in relation to rapid virological response (RVR) in different stages of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 |  | approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 3 years | 
| Sustained virological response (SVR) rate, in relation to early virological response (EVR) in different stages of liver fibrosis in treatment naïve patients with chronic hepatitis C genotype 1 |  | approximately 3 years | 
| Response rates (RVR, EVR, SVR) according to host/virus/treatment-related factors in different stages of liver fibrosis (F>/=3 and </=3) |  | approximately 3 years |