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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
* 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
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) analysis assay
Qualitative
Time frame: up to 24 weeks post treatment
Viral Kinetics
Plasma Ribavirin (RBV) Assays; Immune Response
Time frame: up to 24 weeks post treatment
Neutrophils
If neutrophils are \< 500/mm, neupogen may be added
Time frame: up to 24-48 weeks of treatment
Hemoglobin
If hemoglobin is \< 100g/L, erythropoietin and/or transfusions may be prescribed
Time frame: up to 24-48 weeks of treatment
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