COMPARATIVE EFFICACY OF A HIGH OR LOW-DOSE OF INTERFERON ALPHA(2B) INCHRONIC HEPATITIS-C - A RANDOMIZED CONTROLLED TRIAL

Objectives: Our objective was to determine the relative efficacy of 6 months of treatment with 10 MU versus 3 MU of interferon-alpha(2b) (IF N-alpha), three times weekly, in chronic hepatitis C (HCV) in a random ized trial. Methods: Ten megaunits of IFN-alpha were given to 28 patie nts (group A), and 3 MU were given to 30 patients (group B). After tre atment ended, follow-up was continued for 26 wk. Results: Overall, the sustained response rate was higher in group A than in group B (16/26 or 61.5% vs. 12/28 or 42.9%, p = 0.17), but the difference did not rea ch statistical significance. However, it was higher in group A than in group B among patients with minimal or mild chronic hepatitis (15/20 or 75% vs. 9/24 or 37.5%,p = 0.013). and among those with mild or mode rate fibrosis (15/17 or 88.2% vs. 11/19 or 57.9%, p = 0.042). IFN-alph a treatment significantly reduced histological activity index (HAI) sc oring and all its parameters, except fibrosis, but the decrease was si milar in the two groups. Sex, age, stage, and HCV genotype were statis tically significant predictors of sustained response in univariate ana lysis. However, multiple logistic regression analysis revealed that ad vanced histological stage (severe fibrosis and cirrhosis) was the only significant prognostic factor of poor sustained response (RR = 31.0, 95% CI 2-460, p = 0.01), whereas the presence of genotype 1 had margin al statistical significance (RR = 5.0, 95% CI 0.9-28, p = 0.07). Concl usions: I) A larger dose of IFN-alpha does not improve the sustained r esponse rate; however, it may be of benefit in early stages of chronic hepatitis C. 2) Pretreatment, histological stage, and possibly HCV ge notype appear to be the main prognostic factors of sustained response.