A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

Study Overview
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Brief Summary
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This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 & 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 & 3) or 48 weeks (genotype 1 & 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.

Official Title
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A Multi-Center Study Evaluating the Rate of Genotype 1, 2, 3 & 4 Chronic Hepatitis C Patients With Slow Response / Non-rapid Viral Response to Anti-Viral Treatment of Pegasys (Peginterferon Alfa 2a) in Combination With Copegus (Ribavirin)

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: peginterferon alfa-2a [Pegasys]
* Drug: ribavirin [Copegus]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >/= 18 years of age Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test Documented pre-treatment HCV RNA quantitative result Compensated liver disease (Child-Pugh Grade A) Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin) Exclusion Criteria: Decompensated liver disease (Child-Pugh Class B or C cirrhosis) Co-infection with active hepatitis A and/or hepatitis B History or evidence of a medical condition associated with liver disease other than HCV Signs and symptoms of hepatocellular carcinoma History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease Therapy with antineoplastic treatment </= 6 months prior to study day Diabetes mellitus in subjects receiving an insulin therapy Evidence of severe retinopathy Pregnant or breast-feeding women, and male partners of women who are pregnant

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: peginterferon alfa-2a [Pegasys]<br>* standard treatment, subcutaneously weekly<br>Drug: ribavirin [Copegus]<br>* standard treatment, orally daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment | The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12. | Week 12 | 
| Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment | The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment | Week 12 | 
| Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24 | The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment | Week 24 | 
| Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment. | Week 4 | 
| Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment | The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment. | Week 4 | 
| Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24 | The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study. | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With pEVR to Study Treatment at Week 12 | The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12. | Week 12 | 
| Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment | The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment. | Week 12 | 
| Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24 | The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment. | Week 24 |