High Dose Ribavirin in the Treatment of Chronic Hepatitis C

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment of patients with chronic hepatitis C infected with genotype 1 hepatitis C virus (HCV) consists of combined peginterferon/ribavirin for 48 weeks. Approximately 50% of patients experience sustained virological response which equals cure. All other patients either do not respond or experience recurrence of HCV virus and chronic hepatitis. Important predictors of successful treatment are sustained dosing of both peginterferon and ribavirin. With regard to the latter, clinical evidence indicates that higher ribavirin doses may in fact even improve treatment outcome. However, high ribavirin doses cause hemolytic anemia which require dose reductions. Recent clinical experience show that erythropoetic growth factors, including erythropoetin, can counteract hemolytic anemia caused by antiviral treatment in chronic hepatitis C patients. Therefore, the current trial aims to test whether higher ribavirin doses adapted to a target plasma concentrations instead of a weight-based dosing result in better healing rates, and whether ribavirin-associated hemolytic anemia can be compensated by concommitant erythropoetin treatment.

Using a randomized, controlled, open-label design, the investigators hypothesize that patients with high ribavirin doses adapted to plasma levels experience better viral clearance than patients treated with standard weight-based ribavirin doses. In addition, the investigators hypothesize that erythropoetin treatment will counteract hemolytic anemia induced by ribavirin thereby allowing maintenance of target plasma concentrations without ribavirin dose reductions.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Bern
• Collaborators: Cantonal Hospital of St. Gallen; Roche Pharma AG; University of Basel; University of Lausanne; Waid City Hospital, Zurich
• Treatments: Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Male and female patients aged 18-65 years

• Elevated liver enzymes levels

• Compensated liver disease

• Available liver histology confirming METAVIR F2 fibrosis

• Written consent to participation

Exclusion Criteria

• Age <18, >65

• Prior ribavirin treatment

• Intolerance towards ribavirin, PegIFN or erythropoetin

• Pregnancy or breast feeding

• Relevant cardiovascular or pulmonary disease

• Kidney insufficiency (creatinine clearance <50ml/min)

• Coinfection with HIV or hepatitis B virus

• Hepatic comorbidities (hemochromatosis, Wilson's disease, autoimmune disorders)

• Alcohol consumption > 40g/day

• Psychiatric disorders

• Malignancy (except for basalioma)

• Active consumption of illicit drugs

• Participation in another trial shorter than 3 months prior to inclusion

• Lack of consent