Efficacy Study of New Therapeutic Schedules in Naive Hepatitis C Virus (HCV) Patients Infected With Genotype 3 (HCV-3)

Study Overview
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Brief Summary
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The study aimed at evaluating whether current 24 weeks length of combination treatment is appropriate or not for patients with HCV genotype 3 infection.

Detailed Description
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Patients are randomized to standard length of treatment or to a variable duration: 12 weeks for patients with undetectable HCVRNA at week 4 or 24 or 36 weeks for those with detectable HCV RNA at week 4.

Official Title
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Multicenter Study on Efficacy of New Therapeutic Schedules With Peg-Interferon alpha2b and Ribavirin in Patients With Genotype 3 Chronic HCV( Hepatitis C Virus) Infection

Conditions
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Chronic Hepatitis

Intervention / Treatment
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* Drug: Peg Interferon alpha2b + Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Naive HCV patients HCVRNA positive Normal TSH ANA <1:160 Exclusion Criteria: Portal hypertension Renal failure HBsAg or HIV Alcohol consumption >30 g/day Active IV drug use Chronic systemic diseases

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A1. standard duration<br>Patients were randomly assigned in a 1:1 ratio to two treatment arms. In the standard treatment group (A1), patients were treated for 24 weeks irrespective of the HCV RNA status at week 4 with Peg-interferon alfa-2b at a dose of 1.5 mcg per kilogram of body weight weekly in combination with oral ribavirin administered at a dose of 1000 mg/day for patients with a weight <75 kg or 1200 mg/day for those with a weight of ≥75 kg. Patients enrolled in Arm A1 will be treated for standard 24 weeks duration of treatment with standard dosages of PegInterferon alpha 2b and weight-based dosages of ribavirin. | |
| Experimental: B 1 I or II<br>In the variable treatment group, patients with a virologic response at week 4 will receive treatment for 12 weeks and those without a virologic response at 4 weeks treatment for 36 weeks. Patients without RVR will be treated for 24 or 36 weeks and labelled (B1I) or (B1II, respectively Intervention: different durations of treatment for patients without RVR | Drug: Peg Interferon alpha2b + Ribavirin<br>* B 1 I or II: Experimental variable duration of treatment group according with RVR. In case of RVR present patients will be treated for 12 weeks. Patients without RVR will be treated for 24 (B1I) or 36 (B1II)weeks: different duration of treatment for patients without RVR<br>* Other names: variable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response (SVR) | The primary measure of efficacy will be HCV RNA not detectable in the serum 24 weeks after the end of therapy (SVR). In addition, virological response at the end of treatment and relapse rates will be calculated for each groups. Two analyses will be performed: 1) intention-to-treat analysis; 2) per-protocol analysis. | 6 months after the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genotype 3, Combination treatment, Short treatment