title: A randomized trial of pegylated-interferon-alpha2a plus ribavirin with or without amantadine in the re-treatment of patients with chronic hepatitis C not responding to standard interferon and ribavirin.
abstract: BACKGROUND
  There is yet no established treatment for chronic hepatitis C patients non-responder to standard interferon and ribavirin.
  
  
  OBJECTIVE
  To evaluate efficacy and safety of pegylated-interferon-alpha2a plus ribavirin with or without amantadine in such patients.
  
  
  METHODS
  161 non-responders to standard interferon and ribavirin were randomized into two groups: 81 patients (Group 1) were given weekly Peg-IFN-alpha2a 180 microg plus ribavirin 1,000-1,200 mg/daily for 12 months, 80 patients (Group 2) received weekly Peg-IFN-alpha2a 180 microg plus ribavirin 1,000-1,200 mg/daily and amantadine 200 mg/daily for 12 months.
  
  
  RESULTS
  At the end of follow-up, HCV-RNA was negative in 29.6% of Group 1 and in 21.2% of Group 2 patients (P = 0.22). Patients with genotypes 1 and 4 responded better to bi-therapy (21.7%) than to triple therapy (17.3%, P = 0.5) while among patients with genotypes 2 and 3 there was a trend towards a higher sustained virological response rate when retreated with triple treatment (80% vs. 75%, P = 0.82). On multivariate analysis, genotype 1 or 4, high body mass index and >20% reduction of Peg-interferon were associated with the treatment failure.
  
  
  CONCLUSIONS
  The addition of amantadine does not improve the overall SVR rate in non-responder patients retreated with Peg-IFN and ribavirin; however, about 30% of non-responders may achieve a sustained response, in particular patients with genotypes 2 and 3 show a high SVR (75%).
authors.affiliation: Dipartimento di Gastroenterologia, Ospedale Molinette, Torino, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Ciancio
authors.forename: A
authors.initials: A
authors.lastname: Picciotto
authors.forename: C
authors.initials: C
authors.lastname: Giordanino
authors.forename: A
authors.initials: A
authors.lastname: Smedile
authors.forename: M
authors.initials: M
authors.lastname: Tabone
authors.forename: A
authors.initials: A
authors.lastname: Manca
authors.forename: G
authors.initials: G
authors.lastname: Marenco
authors.forename: P
authors.initials: P
authors.lastname: Garbagnoli
authors.forename: M
authors.initials: M
authors.lastname: Andreoni
authors.forename: G
authors.initials: G
authors.lastname: Cariti
authors.forename: G
authors.initials: G
authors.lastname: Calleri
authors.forename: M
authors.initials: M
authors.lastname: Sartori
authors.forename: S
authors.initials: S
authors.lastname: Cusumano
authors.forename: A
authors.initials: A
authors.lastname: Grasso
authors.forename: R
authors.initials: R
authors.lastname: Rizzi
authors.forename: M
authors.initials: M
authors.lastname: Gallo
authors.forename: M
authors.initials: M
authors.lastname: Basso
authors.forename: M
authors.initials: M
authors.lastname: Anselmo
authors.forename: G
authors.initials: G
authors.lastname: Percario
authors.forename: G
authors.initials: G
authors.lastname: Ciccone
authors.forename: M
authors.initials: M
authors.lastname: Rizzetto
authors.forename: G
authors.initials: G
authors.lastname: Saracco
mesh_terms: D000328:Adult; D000547:Amantadine / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011994:Recombinant Proteins; D012254:Ribavirin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D000547:Amantadine; C100416:peginterferon alfa-2a