POTENTE Study: A Study of Early Virological Response in Naive Patients With Chronic Hepatitis C, Genotype 2 or 3, Treated With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin).

Study Overview
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Brief Summary
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This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180 micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Official Title
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A Prospective, Observational Study to Assess the Virological Response at Week 4 to the Therapy With PEGASYS® (Peginterferon Alfa 2a) Plus COPEGUS® (Ribavirin) in a Population of Treatment Naïve Patients With Chronic Hepatitis C, Genotype 2 or 3.

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; positive serum HCV RNA. Exclusion Criteria: co-infection with HIV or HBV (patients with a positive HBsAg); previous treatment with interferon, or peginterferon and/or ribavirin; severe hepatic dysfunction or decompensated cirrhosis of liver.

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 |
| --- | --- |
| Peginterferon Alfa-2a + Ribavirin<br> | Drug: peginterferon alfa-2a [Pegasys]<br>* 180 micrograms/week sc for 24 weeks<br>Drug: ribavirin [Copegus]<br>* 800mg po daily for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virological Response at Week 48 | Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR). | At Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Rapid Virological Response at Week 4 | Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR. | At Week 4 | 
| Percentage of Participants With Virological Response at Week 24 | Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24). | At Week 24 | 
| Percentage of Participants With Virological Relapse | Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR. | At week 48 | 
| Percentage of Participants With Positive Predictive Value | Positive predictive value is defined as participants with RVR who did not achieve SVR. | At Week 48 | 
| Number of Participants With Any Adverse Events and Any Serious Adverse Events | An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. | Up to 48 weeks | 
| Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48 | Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets. | At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48 | 
| Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48 | Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of >3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance. | Baseline, Week 4, Week 12, Week 24 and Week 48 |