Ribavirin Dose Optimization for the Treatment of Hepatitis C


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.

Full Title of Study: “Ribavirin Dose Optimization for the Treatment of Hepatitis C: A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2013


  • Drug: Peg-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

Arms, Groups and Cohorts

  • Experimental: Peg-interferon alpha-2a, Ribavirin
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) analysis assay
    • Time Frame: up to 24 weeks post treatment
    • Qualitative

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre hospitalier de l’Université de Montréal (CHUM)
  • Collaborator
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jean-Pierre Villeneuve, M.D., Ph.D., Principal Investigator, Centre hospitalier de l’Université de Montréal (CHUM)


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