title: Additive therapeutic effects of the liver extract preparation mixture adelavin-9 on interferon-beta treatment for chronic hepatitis C.
abstract: OBJECTIVE
  We previously reported that intravenous interferon-beta administration was effective in treating patients with chronic hepatitis C and that there was no significant correlation between the response to therapy and host in vitro immunoglobulin production. The aims of this study were to evaluate the additive effect of a liver extract preparation and flavin adenine dinucleotide mixture and to reevaluate the correlation.
  
  
  METHODS
  65 patients with chronic hepatitis C received intravenously 6 million units of interferon-beta and 2 mL of a liver extract preparation and flavin adenine dinucleotide mixture. The results of this study were compared with those of our previous study, on interferon-beta monotherapy in 91 patients with chronic hepatitis C. In addition, peripheral blood mononuclear cells were obtained before interferon-beta administration and cultured. Immunoglobulin concentrations in their supernatants were measured and the correlation with the interferon response was evaluated.
  
  
  RESULTS
  The virological end-of-treatment or sustained response occurred in 49 of 58 cases (84.5%), and 16 of 58 cases (27.6%), respectively. Biochemical end-of-treatment or sustained responses occurred in 22 of 58 cases (37.9%), and 30 of 58 cases (51.7%), respectively. These response rates were higher than those reported in our previous study of interferon monotherapy. Monovariate analysis indicated that the use of the liver extract preparation and flavin adenine dinucleotide mixture was a significant predictor of the virological end-of-treatment response and the sustained biochemical response, but by multivariate analysis these relationships were not significant. Immunoglobulin production was not correlated with the virological and biochemical responses.
  
  
  CONCLUSIONS
  This study indicated that combination therapy with intravenous interferon-beta and the liver extract preparation and flavin adenine dinucleotide mixture was more effective than intravenous interferon-beta monotherapy. However, no correlation between the interferon response and in vitro immunoglobulin production was observed.
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: Shinichirou
authors.initials: S
authors.lastname: Tada
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Masuda
authors.forename: Tomoyoshi
authors.initials: T
authors.lastname: Kamiya
authors.forename: Jiro
authors.initials: J
authors.lastname: Nishida
authors.forename: Masahiro
authors.initials: M
authors.lastname: Yoshioka
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Ishii
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004357:Drug Synergism; D005260:Female; D005182:Flavin-Adenine Dinucleotide / Q000627:therapeutic use*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000378:metabolism; D006801:Humans; D007136:Immunoglobulins / Q000096:biosynthesis; D016899:Interferon-beta / Q000627:therapeutic use*; D008110:Liver Extracts / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D007136:Immunoglobulins; D008110:Liver Extracts; C102331:Adelavin 9; D005182:Flavin-Adenine Dinucleotide; D016899:Interferon-beta