Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment

Study Overview
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Brief Summary
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The purpose of this study is to test the potential antiviral efficacy of triple-combination therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype 3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).

Detailed Description
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i) Obtain preliminary information on the association between important baseline and on-treatment factors and SVR in this patient population. Variables to be examined may include gender, age, advanced fibrosis or cirrhosis (F3 or F4 estimated by Fibroscan), baseline viral load, RVR, wk 8 viral load, end-of-treatment viral response. ii) Evaluate adverse events. iii) Evaluate viral resistance.

Official Title
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Triple-Therapy With PegInterferon α-2b + Ribavirin + Boceprevir in Patients With HCV Genotype 3 Who Previously Failed Treatment With PegInterferon α + Ribavirin

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Boceprevir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be eligible for the study if they meet the following inclusion criteria: 18 years of age or older Infected with HCV genotype 3 (mixed genotypes are NOT permitted) Have received at least 12 weeks of previous treatment with peginterferon-α + ribavirin Detectable serum HCV-RNA No significant co-morbid conditions Liver biopsy is not necessary Cirrhotic patients will be eligible to participate if Child-Pugh class A (maximum 15% of subjects) Exclusion Criteria: Subjects will be excluded from participation in this study if the following conditions are present: Significant comorbidities: uncontrolled psychiatric conditions including severe depression, cardiovascular, respiratory, renal or metabolic conditions, active carcinoma. Active substance abuse within the past 12 months Co-infection with hepatitis B or HIV Decompensated cirrhosis (Child-Pugh class B or C) Significant cytopenia - any of the following: platelets <80 x 109/L, neutropenia <1.2 x 103/L, Hb <120 g/l for men or 110 g/l for women Lack of informed consent Previous null-responders (<2 log10 decrease at week 12 with previous PR therapy)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Boceprevir<br> | Drug: Boceprevir<br>* All patients will receive a 4-week lead-in with Peginterferon and Ribavirin therapy, followed by 24 weeks of Pegetron 1.5microg/kg + weight-based ribavirin + boceprevir 800mg tid. HCV RNA (Cobas TaqMan) will be measured at baseline and at treatment weeks 4, 6,8,12,16,20,24 and 28, and post-treatment weeks 12 and 24 (to obtain SVR-12 and SVR-24 results).<br>* Other names: Hepatitis C Virus (HCV) Protease Inhibitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Response (SVR) at 24 Weeks Post Treatment | Sustained Virologic Response (SVR) is evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. HCV RNA is measured using Cobas TaqMan.Of the 6 subjects who completed the treatment, 3 obtained SVR at 24 weeks post treatment. | 24 weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Boceprevir, Hepatitis C Genotype 3