Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)

Study Overview
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Brief Summary
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The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antiviral therapy prior to the current study. Only patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will also explore the influence of liver fibrosis stage on the chances of achieving a sustained virologic response.

Official Title
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A Non-interventional Phase IV Survey to Assess the Antiviral Effectiveness of PegIntron® and Rebetol® Treatment According to the Stage of Liver Fibrosis in Previously Untreated Patients With Genotype 1/4/5/6 Chronic Hepatitis C (CHC) (PRACTICE)

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Biological: PegIntron (peginterferon alfa-2b; SCH 54031)
* Drug: Rebetol (ribavirin; SCH 18908)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously untreated ('treatment naïve') adults (18 year or more) for whom the treating physician has decided to start treatment with PegIntron and Rebetol Detectable Hepatitis C Virus - Ribonucleic Acid (HCV-RNA) in serum by Polymerase Chain Reaction (PCR) Repeated (with at least a 1 month interval) serum transaminase (alanine aminotransferase [ALT]) levels above the upper normal limit for gender Documented chronic hepatitis C (CHC) of genotype 1/4/5/6 A representative liver biopsy within 1 year prior to inclusion, allowing fibrosis grading into METAVIR score F0, F1, F2, F3 or F4 Exclusion Criteria: Known hypersensitivity for any active ingredient or constituent Pregnancy or lactation Medically documented history of severe psychiatric disturbance, including severe depression, suicidal ideation or suicide attempt Medically documented history of severe heart disease, including unstable or uncontrolled cardiac disease, within the last 6 months Severely weakening medical condition, including chronic renal insufficiency or creatinine clearance <50 mL/minute Hepatitis of immunologic origin or medically documented history of auto-immune disease Severe hepatic disorder or decompensated cirrhosis Pre-existing thyroid disorder, except if under control with classical treatment Epilepsy or central nervous system disorder Hemoglobin pathology, eg, thalassaemia, sickle cell anemia

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 |
| --- | --- |
| PegIntron Plus Rebetol<br>Previously untreated patients infected with HCV genotype 1, 4, 5, or 6. | Biological: PegIntron (peginterferon alfa-2b; SCH 54031)<br>* PegIntron 1.5 ug/kg body weight per week subcutaneously for 48 weeks<br>* Other names: SCH 54031;Drug: Rebetol (ribavirin; SCH 18908)<br>* Rebetol administered based on body weight 800-1200 mg/day (<65 kg: 800 mg; 65 - 85 kg: 1000 mg; >85 kg: 1200 mg) orally for 48 weeks<br>* Other names: SCH 18908;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Study Participants Who Had a Virological Response (VR) at Week-72 | VR was defined as the absence of Hepatitis C virus Ribonucleic Acid (HCV RNA) in a qualitative Polymerase Chain Reaction (PCR) test. Participants who dropped out or were withdrawn from treatment were considered not to respond. | Treatment Week 72 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis C