Daily Interferon Regimen for Chronic HCV

authors- Raffaele Bruno, Division of Infectious and Tropical Diseases, University of Pavia, IRCCS San Matteo, Pavia, Italy; Maurizia Debiaggi, Institute of Microbiology, University of Pavia, Pavia, Italy; Paolo Sacchi, Elena Maffezzini, Francesca Zara, Enrico Brunetti, Carlo Filice, Savino F.A. Patruno, Gaetano Filice, Division of Infectious and Tropical Diseases, University of Pavia, IRCCS San Matteo, Pavia, Italy

Abstract

Objective: To compare the safety and efficacy of two regimens of lymphoblastoid interferon, 3MU daily for 12 months vs 6MU three times weekly for 12 months, 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 Hospital in Pavia, Italy, between 1997 and 1998. Patients: 100 treatment-naive outpatients with chronic hepatitis C genotype 1b participated in the study.

Main Outcome Measures: We measured serum hepatitis C virus (HCV) RNA levels, serum alanine aminotransferase (ALT), histological activity index score and fibrosis stage. Patients were classified as follows: primary responders (PR) when ALT normalised and HCV-RNA became negative during treatment; nonresponders (NR) if ALT remained elevated and HCV-RNA remained positive during treatment; sustained responders (SR) when HCV-RNA became persistently negative and ALT became normalised during treatment and for at least 6 months after treatment; relapsers (R) were PR whose ALT returned to abnormal values 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. Adverse effects were comparable in the two groups and were never serious enough to require withdrawal of therapy.

Conclusion: These findings support the choice of a 3MU daily regimen of lymphoblastoid interferon for the treatment of patients with chronic HCV infection and provide corroborative evidence in support of molecular virological data suggesting a relatively rapid viral turnover in this clinical setting.

[Clin Drug Invest18(1):11-16, 1999. © 1999 Adis International Limited]