USE OF INTRON AND RIBAVIRIN FOR HEPATITIS C

This is a double-blind, placebo controlled, randomized parallel group study conducted in two stages comparing 4 levels of ribavirin (400, 600, 800 and 1000-1200 mg/day) plus Intron A 3 MU TIW and Intron A MU TIW plus placebo in patients with chronic hepatitis C who have not previously been treated with interferon. The Objectives of this two- stage clinical trial are: Stage1: To characterize the relationship between the dose of ribavirin and change in hemoglobin values from baseline at week 4 of treatment when ribavirin is used in combination with Intron A MU TIW, and to identify the hioghest dose of ribavirin that does not significantly increase the hemolysis (decrease in hemoglobin) over that observed with Intron A alone. To evaluate the HCV kinetics in patients treated with Intron A plus placebo and Intron A plus ribavirin at four different doses. Stage 2: To evaluate the safety and efficacy )as measured by loss of HCV RNA) of Intron A plus the dose of Ribavirin identified in stage I and compare it to Intron A plus placebo and Intron A plus ribavirin 1000-1200 mg/day. All patients in stage 1 and stage 2 will complete 24 weeks of treatment and 24 weeks of follow-up. Safety, tolerance and efficacy will be evaluated at weeks 2, 4, 8, 12, 16, and 24 during treatment and 4, 12 and 24 weeks following the end of the therapy. The primary efficacy parameter for his study is the loss of serum HCV-RNA/qPCR 24 weeks following the end of therapy. In addition, the overall response based on loss of HCV-RNA and histologic improvement 24 weeks following the end of therapy will be assessed.