title: Natural human interferon beta plus ribavirin combination therapy in Japanese patients infected with hepatitis C virus and a high viral load.
abstract: OBJECTIVE
  The aim of this pilot study was to determine the safety and efficacy of natural human interferon beta (nIFNbeta) plus ribavirin (RBV) in patients with chronic hepatitis C who did not respond to pegylated interferon alpha (PEG-IFN), with special emphasis on the incidence of mental disorders or refusal for fear of adverse effects.
  
  
  METHODS
  We studied 19 patients with HCV genotype 1b, 2a or 2b and a high viral load, including 8 patients with mental disorders. They were treated with nIFNbeta-RBV. Eleven patients with HCV genotype 1b of these patients were treated with nIFNbeta-RBV for 48 weeks (group A), and compared with 22 matched controls treated with PEG-IFN plus RBV for 48 weeks (group B). The other 8 patients with HCV genotype 2 were treated with nIFNbeta-RBV for 24 weeks.
  
  
  RESULTS
  Six of 8 patients with mental disorders and 9 of 11 patients without mental disorders completed nIFNbeta-RBV therapy; 1 patient with mental disorder dropped out due to exacerbation of depression, and 3 patients suspended the therapy due to insufficient response. The sustained virological response (SVR) was 27% (3/11) in group A and 41% (9/22) in group B (p = 0.70). During treatment, platelet count increased in group A but not in group B. SVR was 88% (7/8) in patients of genotype 2 and high viral load treated with nIFNbeta plus RBV.
  
  
  CONCLUSIONS
  nIFNbeta-RBV therapy offers sufficient safety and efficacy for patients with mental disorders, and thus could represent an excellent second-line therapy for subpopulations that are not suitable for PEG-IFN-RBV.
authors.affiliation: Department of Hepatology, Toranomon Hospital, Tokyo.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Katamura
authors.forename: Fumitaka
authors.initials: F
authors.lastname: Suzuki
authors.forename: Norio
authors.initials: N
authors.lastname: Akuta
authors.forename: Hitomi
authors.initials: H
authors.lastname: Sezaki
authors.forename: Hiromi
authors.initials: H
authors.lastname: Yatsuji
authors.forename: Norihiro
authors.initials: N
authors.lastname: Nomura
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Kawamura
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Hosaka
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kobayashi
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Suzuki
authors.forename: Satoshi
authors.initials: S
authors.lastname: Saito
authors.forename: Yasuji
authors.initials: Y
authors.lastname: Arase
authors.forename: Kenji
authors.initials: K
authors.lastname: Ikeda
authors.forename: Mariko
authors.initials: M
authors.lastname: Kobayashi
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Kumada
mesh_terms: D000328:Adult; D000368:Aged; D044466:Asian People / Q000235:genetics; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000235:genetics / Q000821:virology; D006801:Humans; D016899:Interferon-beta / Q000008:administration & dosage*; D008297:Male; D001523:Mental Disorders / Q000188:drug therapy / Q000235:genetics / Q000821:virology; D008875:Middle Aged; D010865:Pilot Projects; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage*; D019562:Viral Load
chemical_list: D012254:Ribavirin; D016899:Interferon-beta