title: Interferon alfa2a induction therapy in combination with ribavirin and amantadine for the treatment of naive patients with chronic HCV infection.
abstract: Pilot studies have suggested that the addition of amantadine to interferon (IFN) is effective against hepatitis C virus (HCV). Furthermore, IFN induction therapy seems to improve virological response rates. In this open, randomized, multicentre trial we compared safety and efficacy of a triple therapy comprising IFN alpha 2a, ribavirin and amantadine using high induction doses (6 MU IFN alpha daily for the first 6 weeks) against a therapy with standard IFN alpha dosages over the entire treatment period plus amantadine and ribavirin. A total of 158 naive patients with chronic HCV infection were randomized 1:1. Group A (n = 81): induction therapy with 6 MU IFN alpha daily for 6 weeks, followed by 6 MU three times a week (tiw) for 18 weeks and then 3 MU tiw until week 48. Group B (n = 77): standard therapy with 6 MU IFN alpha tiw for 24 weeks, followed by 3 MU until week 48. All patients received oral ribavirin (10 mg/kg/day) and amantadine (200 mg/day). The triple therapy was safe and well tolerated. There were no significant differences between the groups with respect to biochemical response rates. Groups A and B did not differ in virological response rates at the end of treatment (33%vs 35%) or at the end of the 6 month follow up period (37%vs 39%). We could not detect favourable effects on sustained virological response rates using induction therapy, in either genotype 1 or non-1 infected patients. In summary, induction therapy with 6 MU IFN alpha daily did not result in increased overall response rates compared with standard IFN alpha dosages of 6 MU tiw.
authors.affiliation: Department of Medicine, Division of Gastroenterology, Hepatology and Infectious Diseases, University Hospital of Heidelberg, Germany. sigrid.engler@gmx.de
authors.forename: S
authors.initials: S
authors.lastname: Engler
authors.forename: C
authors.initials: C
authors.lastname: Flechtenmacher
authors.forename: K H
authors.initials: KH
authors.lastname: Wiedemann
authors.forename: R
authors.initials: R
authors.lastname: Gugler
authors.forename: W
authors.initials: W
authors.lastname: Stremmel
authors.forename: B
authors.initials: B
authors.lastname: Kallinowski
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000547:Amantadine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects* / Q000502:physiology; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000637:Transaminases / Q000097:blood
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D012254:Ribavirin; D000547:Amantadine; D000637:Transaminases; D000410:Alanine Transaminase