Chronic Hepatitis C
Conditions
Keywords
Ribavirin, Pegasys, Hepatitis
Brief summary
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.
Interventions
DRUGPeg-interferon alpha-2a, Ribavirin
* 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
Sponsors
Hoffmann-La Roche
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) analysis assay | up to 24 weeks post treatment | Qualitative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral Kinetics | up to 24 weeks post treatment | Plasma Ribavirin (RBV) Assays; Immune Response |
| Neutrophils | up to 24-48 weeks of treatment | If neutrophils are \< 500/mm, neupogen may be added |
| Hemoglobin | up to 24-48 weeks of treatment | If hemoglobin is \< 100g/L, erythropoietin and/or transfusions may be prescribed |
Countries
Canada
Outcome results
None listed