Aim: To compare the efficacy of high-dose induction with standard dose interferon therapy for the treatment of chronic hepatitis C virus at the Dallas Veterans Affairs Medical Center.
Methods: Patients were randomized to receive 5 million units daily interferon-alpha2b for 4-weeks followed by 44-weeks for genotype 1 or 20 weeks for non-genotype 1 of standard dose therapy (3 million units three times a week) or standard dose therapy for total treatment duration. Daily weight-based ribavirin was used for entire therapy interval.
Results: Forty-five patients were enrolled in the trial with genotype 1 comprising 75.6% of the sample. Cirrhosis or bridging-fibrosis was present in 69% of the patients. Of the 29 liver biopsies available for Knodell scoring, 41% and 51% had scores of 6-10 and 11-15, respectively. Rates of sustained virological response did not differ significantly between the two treatment groups. Therapy type and/or early intervention for depression did not affect the rate of therapy discontinuation, which was 26.6%.
Conclusion: The rate of sustained virological response was similar between the two treatment groups and higher than anticipated among patients with cirrhosis or bridging-fibrosis. The rate of therapy discontinuation was also higher than anticipated but was not attributable to therapy type or untreated depression.