Ribavirin Dose Optimization for the Treatment of Hepatitis C

Study Overview
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Brief Summary
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Patients for whom treatment with peginterferon plus ribavirin was unsuccessful represent a category of patients for whom there is currently no worthwhile therapeutic alternative. Several studies have shown that there is a relation between plasma ribavirin concentrations and treatment response. Adequate ribavirin plasma concentrations, especially during the first 12 weeks of treatment, should be associated with a better chance of response to the treatment. The strategy for this study will be to use a loading dose of ribavirin before beginning the treatment with peg-interferon, thereby allowing for optimal ribavirin concentrations to be reached, and possibly improving the effectiveness of the treatment.

Official Title
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Ribavirin Dose Optimization for the Treatment of Hepatitis C: A Pilot Study

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Peg-interferon alpha-2a, Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Chronic hepatitis C and failure of prior treatment with peginterferon plus ribavirin (non-response: HCV-RNA decreased less than 2 logs after 3 months of treatment; relapse: HCV-RNA that becomes positive again after treatment is stopped Compensated hepatic disease (Child-Pugh ≤ 6) Provision by patient of his or her written consent Exclusion Criteria: Females who are pregnant or lactating will be excluded Renal failure (estimated glomerular filtration rate < 50 ml/min) A contraindication to treatment with peginterferon plus ribavirin (uncontrolled psychiatric illness, pregnancy/nursing/non-use of effective contraceptive method, uncontrolled epilepsy for at least 6 months, heart failure, unstable angina, hemoglobin < 120 g/L, neutrophils < 1,000/mm3, platelets < 50 x 109/L, or any other condition that, in the investigator's opinion, contraindicates use of the treatment)

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: Peg-interferon alpha-2a, Ribavirin<br>Adult patients with chronic hepatitis C and failure of prior treatment with peginterferon plus ribavirin(non-response or relapse). This is a pilot study with no control group. | Drug: Peg-interferon alpha-2a, Ribavirin<br>* 4 weeks RBV priming; 24 or 48 weeks of Pegasys+Ribavirin (RBV) Treatment (depending on genotype); 24 weeks Follow-Up Patients will receive PEGASYS® 180 µg in 0.5 mL (prefilled syringes) administered sc once weekly. Specific guidelines for adjusting the dose of PEGASYS® are provided in the product monograph.All PEGASYS® administrations will be via the sc route using sterile technique. Ribavirin 200 mg tablets<br>* Other names: Ribavirin (COPEGUS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) analysis assay | Qualitative | up to 24 weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Kinetics | Plasma Ribavirin (RBV) Assays; Immune Response | up to 24 weeks post treatment | 
| Neutrophils | If neutrophils are < 500/mm, neupogen may be added | up to 24-48 weeks of treatment | 
| Hemoglobin | If hemoglobin is < 100g/L, erythropoietin and/or transfusions may be prescribed | up to 24-48 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ribavirin, Pegasys, Hepatitis