Randomized trial comparing three different regimens of alpha-2a-interferon in chronic hepatitis C

✍ Scribed by Liliana Chemello; Paola Bonetti; Luisa Cavalletto; Fabiola Talato; Valter Donadon; Pietro Casarin; Fabio Belussi; Mario Frezza; Franco Noventa; Patrizia Pontisso; Luisa Benvegnù; Carla Casarin; Alfredo Alberti

• Book ID: 102853628
• Publisher: John Wiley and Sons
• Year: 1995
• Tongue: English
• Weight: 769 KB
• Volume: 22
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.1840220303

✦ Synopsis

Alpha-interferon (IF"+) is an effective treatment for chronic hepatitis C, but only 20% to 30°C of patients are apparently cured with the currently recommended schedule of 3 MU given three times a week for 6 months.

To evaluate the efficacy of more aggressive treatment regimens, we have conducted a randomized trial in 174 patients with chronic hepatitis C using three different schedules: (I) 12-month treatment starting with 6 MU/ three times a week and decreasing the dose on the basis of serum alanine transaminase (ALT) activities (group A: 59 cases); (2) fixed dose of 3 MU three times a week for 12 months (Group B: 61 cases), ( 3) fixed dose of 6 MU three times a week for 6 months (Group C: 54 cases). Patients were evaluated during therapy for biochemical and virological response and followed for at least 12 months after therapy to assess long-term efficacy and liver histological outcome. The genotype of infecting HCV was also analyzed in all patients, and predictors of response were determined by multivariate analysis. Serum ALT became normal during therapy in 76% of patients (95% confidence interval [CI]: 63 to 86), 65% (CI: 52 to 77), and 74% (CI: 60 to 85) in groups A, B, and C, respectively (P = NS). The corresponding figures for sustained response 12 months after therapy were (CI: 36 to 62), 31% (CI: 20 to 44), and 28% (CI: 16 to 42) (A vs.

B, P = .06; A vs. C, P = 0.03). Eighty-six percent of patients with sustained response cleared HCV-RNA &om serum, Abbreviations: ALT, alanine transaminase; HCV, hepatitis C virus; IFN-Q, interferon-alfa.

From the 'Clinica Medica 2,