title: Interferon and thymosin combination therapy in naive patients with chronic hepatitis C: preliminary results.
abstract: OBJECTIVE
  This randomized study was performed to compare the efficacy of interferon-alpha (IFN-alpha) + thymosin alpha 1 (Talpha1) treatment to that of IFN-alpha alone in light of biochemical and virological response of naive patients with chronic hepatitis C.
  
  
  METHODS
  Seventeen patients were treated with IFN alpha-2b (3 million units MU three times a week) + Talpha1 (1 mg twice weekly); the other 17 patients received only IFN alpha-2b at the same dose. All patients were treated for 6 months and followed up for 12 months. Biochemical (ALT values) and virological (HCV-RNA) responses to treatment were determined.
  
  
  RESULTS
  Combination therapy showed significantly higher efficacy than monotherapy in achieving biochemical and virologic end-of-treatment response (p<0.05). At 12 month follow-up, the sustained biochemical response was slightly greater in patients treated with combination therapy than in those treated with monotherapy. No significant difference in response by HCV-1b subtype was observed between the two treatment groups; however, HCV-2c subtype showed a trend to responding better to IFN-alpha+Talpha1 than to IFN-alpha alone.
  
  
  CONCLUSIONS
  These data suggest that the immune modulator Talpha1 may be additive or synergistic with IFN-alpha in normalizing end-treatment biochemical and virological responses in patients with chronic hepatitis C. Higher doses and/or more prolonged courses may improve the sustained response rates to this treatment.
authors.affiliation: Istituto di Medicina Interna, Universita' di Firenze, Florence, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Moscarella
authors.forename: G
authors.initials: G
authors.lastname: Buzzelli
authors.forename: R G
authors.initials: RG
authors.lastname: Romanelli
authors.forename: M
authors.initials: M
authors.lastname: Monti
authors.forename: C
authors.initials: C
authors.lastname: Giannini
authors.forename: G
authors.initials: G
authors.lastname: Careccia
authors.forename: E M
authors.initials: EM
authors.lastname: Marrocchi
authors.forename: A L
authors.initials: AL
authors.lastname: Zignego
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics / Q000276:immunology; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000032:analysis; D020133:Reverse Transcriptase Polymerase Chain Reaction; D000077596:Thymalfasin; D013947:Thymosin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D016898:Interferon-alpha; D012367:RNA, Viral; D013947:Thymosin; D000410:Alanine Transaminase; D000077596:Thymalfasin