title: Efficacy of natural BALL-1 interferon-alpha treatment for patients with chronic hepatitis C and a possible enhancing effect of a twice-daily starting regimen with interferon-beta.
abstract: OBJECTIVE
  Two distinct natural interferon-alpha (BALL-1 and Namalwa) are available for patients with chronic hepatitis C in Japan, but the efficacy has not been well documented. We investigated two studies using a natural BALL-1 interferon-alpha treatment for chronic hepatitis C and assessed its efficacy.
  
  
  METHODS
  In interferon-alpha monotherapy (Study I), 42 patients with chronic hepatitis C received 10 mega units of BALL-1 interferon-alpha intramuscularly consecutively for an initial 2 weeks followed by three times a week for 6 months totally. In a combination therapy of natural interferon-alpha and interferon-beta (Study II), 24 patients received intravenous 3 mega units of interferon-beta twice daily for the initial 2 weeks followed by 10 mega units of natural BALL-1 interferon-alpha consecutively for 2 weeks and three times a week for 6 months totally. Efficacy and predictive factors for sustained viral response was investigated.
  
  
  RESULTS
  Study II included significant younger patients than study I. Sustained virological response was obtained in 31.0% in Study I and 56.5% in Study II by intention-to-treat analysis. Sustained viral response in the group of genotype 1b and viral load more than 100 KIU/mL was 3/23 (13.0%) and 8/18 (44.4%) in Study I and II, respectively. The response rate in Study II was higher than that of Study I especially among the patients with high pretreatment viral load or genotype 1b (p<0.05). Multivariate analysis showed that pre-treatment HCV-RNA levels, HCV-genotype, and histological staging before the interferon treatment were significant predictive factors of sustained viral response.
  
  
  CONCLUSIONS
  These studies suggest that natural BALL-1 interferon-alpha is useful for inducing sustained viral response in patients with chronic hepatitis C, even in those possessing genotype 1b and high viral load. In addition, the combination therapy with a starting regimen with twice-daily interferon-beta administration for 2 weeks may be more effective than monotherapy.
authors.affiliation: Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan.
authors.forename: Hirotoshi
authors.initials: H
authors.lastname: Ebinuma
authors.forename: Hidetsugu
authors.initials: H
authors.lastname: Saito
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Tada
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Nakamoto
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kurita
authors.forename: Kumi
authors.initials: K
authors.lastname: Kitamaura
authors.forename: Hitomi
authors.initials: H
authors.lastname: Horikawa
authors.forename: Naoki
authors.initials: N
authors.lastname: Kumagai
authors.forename: Kanji
authors.initials: K
authors.lastname: Tsuchimoto
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Ishii
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
mesh_terms: D000328:Adult; D004334:Drug Administration Schedule; D004357:Drug Synergism; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D016899:Interferon-beta / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged
chemical_list: D016898:Interferon-alpha; D016899:Interferon-beta