Efficacy of high dose of recombinant alpha 2b interferon on long term response in chronic hepatitis C and cirrhosis: prospective randomized multicentre study

Background/Aims. The long-term response to alpha-Interferon in HCV-related chronic liver diseases is disappointing A randomized controlled trial was c onducted to investigate. 1) if doubling the standard regimen of 3 MU recomb inant alpha 2b-interferon thrice weekly for one year could improve the long -term response, and 2) the efficacy of these two schedules in cirrhotic pat ients. Patients and Methods. A series of 80 anti-HCV positive patients with biopsy proven liver disease (52 chronic hepatitis and 28 cirrhosis) were randomiz ed to receive either 3 MU or 6 MU alpha 2b-interferon. Results, Based on. "intention-to-treat analysis", 38% in the 3 MU group and 53% in the 6 MU group had end-of-treatment response. After 24 months, 18% had long-term response: 5% in 3 MU group and 30% in 6 MU group (p<0.008). H CV genotype had no influence on the response rate. Thirty-eight percent of the cirrhotics treated with 6 MU had long-term response, while none of thos e treated with 3 MU had long-term response (difference 38%; 95% confidence internal 10%-67%; p=0.03). At the end of treatment, 38% of patients lost HC V-RNA. After 24 months only 19% remained HCV-RNA negative: 12 patients (31% ) in the 6 MU group and 2 (6%) in the 3 MU group (p<0.05). Conclusions. 6 MU of alpha 2b-interferon thrice weekly for 12 months is sig nificantly better than 3 MU in inducing a long-term response and permanent loss of HCV-RNA. This result is particularly striking in the subgroup of ci rrhotics.