Interferon-α plus amantadine in chronic hepatitis C resistant to interferon alone: a pilot randomized study

• Published in: Journal of viral hepatitis Vol. 8; no. 4; pp. 284 - 286
• Main Authors: Gaeta, G. B., Stornaiuolo, G., Stanzione, M., Ascione, T., Pasquazzi, C., Taliani, G., Cimino, L., Budillon, G., Piccinino, F.
• Format: Journal Article
• Language: English
• Published: Oxford UK Blackwell Science Ltd 01.07.2001
• Subjects: amantadine; Amantadine - therapeutic use; Antiviral Agents - therapeutic use; chronic hepatitis C; Drug Resistance, Microbial; Drug Therapy, Combination; Female; Follow-Up Studies; Hepatitis C virus; Hepatitis C, Chronic - blood; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - metabolism; Humans; IFN-resistant; Interferon-alpha - blood; Interferon-alpha - therapeutic use; interferon-α; Male; Pilot Projects
• ISSN: 1352-0504; 1365-2893
• DOI: 10.1046/j.1365-2893.2001.00298.x

The optimal therapy for patients with chronic hepatitis C who have not responded to interferon (IFN) is still an unsolved issue. The aim of this study was to evaluate the efficacy and tolerability of a high dose of IFN‐α2a plus amantadine for chronic hepatitis C patients who were non‐responders to a previous course of IFN. Forty consecutive patients with chronic hepatitis C, genotype 1b, who had not responded to IFN‐α, were randomized to receive: (i) IFN 4.5 MU daily plus amantadine 200 mg/day for 4 weeks and then IFN 6 MU thrice weekly plus amantadine 200 mg/day for an additional 5 months (group A) or (ii) IFN alone at the same dosage and duration (group B). After 1 month of therapy, normal alanine aminotransferase (ALT) values were observed in three of 21 (14.3%) patients in group A and in three of 19 (15.8%) in group B; serum hepatitis C virus (HCV)‐RNA clearance was observed in one patient (4.8%) in group A and in six (31.6%) in group B. At the end of treatment, six patients (28.6%) in group A and three (15.8%) in group B had normal ALT levels; however, HCV‐RNA in serum was detectable in all of them at levels comparable to the basal values; an ALT relapse occurred within 3 months of stopping therapy. The combination of daily IFN plus amantadine was ineffective in this setting.