Daily interferon regimen for chronic hepatitis C - A prospective randomised study

Objective: To compare the safety and efficacy of two regimens of lymphoblas toid interferon, 3MU daily for 12 months vs 6MU three times weekly for 12 m onths, for the treatment of patients with chronic hepatitis C. Design: This was a prospective, randomised, nonblind study. Setting: The study was conducted in outpatients attending the University Ho spital in Pavia, Italy, between 1997 and 1998. Patients: 100 treatment-naive outpatients with chronic hepatitis C genotype Ib participated in the study. Main Outcome Measures: We measured serum hepatitis C virus (HCV) RNA levels , serum alanine aminotransferase (ALT), histological activity index score a nd fibrosis stage. Patients were classified as follows: primary responders (PR) when ALT normalised and HCV-RNA became negative during treatment; nonr esponders (NR) if ALT remained elevated and HCV-RNA remained positive durin g treatment; sustained responders (SR) when HCV-RNA became persistently neg ative and ALT became normalised during treatment and for at least 6 months after treatment; relapsers (R) were PR whose ALT returned to abnormal value s and HCV-RNA became positive again after the end of treatment. Results: 50 patients received 3MU daily, of whom 42 (84%) were PR and eight (16%) were NR. Of the 42 PR, 23 (54.7%) were SR and 19 (45.3%) were R. 50 patients received 6MU three times weekly, of whom 21 (42%) were PR and 29 ( 58%) were NR. Of the 21 PR, five (23.8%) were SR and 16 (76.2%) were R. Adv erse effects were comparable in the two groups and were never serious enoug h to require withdrawal of therapy. Conclusion: These findings support the choice of a 3MU daily regimen of lym phoblastoid interferon for the treatment of patients with chronic HCV infec tion and provide corroborative evidence in support of molecular virological data suggesting a relatively rapid viral turnover in this clinical setting .