title: Interferon-alpha plus amantadine in chronic hepatitis C resistant to interferon alone: a pilot randomized study.
abstract: 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-alpha2a 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-alpha, 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.
authors.affiliation: Dipartimento di Malattie Infettive Seconda Università di Napoli, Napoli, Italy. giovannib.gaeta@unina2.it
authors.forename: G B
authors.initials: GB
authors.lastname: Gaeta
authors.forename: G
authors.initials: G
authors.lastname: Stornaiuolo
authors.forename: M
authors.initials: M
authors.lastname: Stanzione
authors.forename: T
authors.initials: T
authors.lastname: Ascione
authors.forename: C
authors.initials: C
authors.lastname: Pasquazzi
authors.forename: G
authors.initials: G
authors.lastname: Taliani
authors.forename: L
authors.initials: L
authors.lastname: Cimino
authors.forename: G
authors.initials: G
authors.lastname: Budillon
authors.forename: F
authors.initials: F
authors.lastname: Piccinino
mesh_terms: D000547:Amantadine / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000627:therapeutic use*; D004352:Drug Resistance, Microbial; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism; D006801:Humans; D016898:Interferon-alpha / Q000097:blood / Q000627:therapeutic use*; D008297:Male; D010865:Pilot Projects
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D000547:Amantadine