title: Retreatment of non-responder or relapser chronic hepatitis C patients with interferon plus ribavirin vs interferon alone.
abstract: OBJECTIVE
  Interferon-alpha treatment of chronic hepatitis C is beneficial in only 20-30% of patients. This study evaluates if combination therapy with Interferon-alfa plus ribavirin is effective in inducing a response in patients who did not respond to, or relapsed after, a standard Interferon-alfa treatment.
  
  
  METHODS
  A total of 88 patients, 49 non-responders and 39 relapsers to previous Interferon-alfa therapy, were randomized to receive either natural Interferon-alfa (6 MU t.i.w.) plus ribavirin (1000 mg/daily) or natural Interferon-alfa alone (6 MU t.i.w.) for 6 months. All were followed for 12 months after stopping therapy. Serum aminotransferase levels were assessed monthly and HCV RNA was evaluated by RT-PCR (Amplicor, Roche) at end of therapy and the end of follow-up.
  
  
  RESULTS
  After treatment, a higher response rate defined as return to normal of aminotransferases and absence of serum HCV RNA was observed among patients treated with Interferon-alfa-ribavirin: 4/28 (14%) vs 1/21 (5%) non-responder patients and 9/19 (47%) vs 5/20 (25%) in the relapsers group. At the end of follow-up, a sustained response was found only in the combination treatment group: 4% and 32% in non-responder and relapser patients, respectively.
  
  
  CONCLUSIONS
  Our results suggest that retreatment with natural Interferon-alfa plus ribavirin is more effective than Interferon-alfa alone in increasing the response rate in patients with chronic hepatitis C who relapse after a previous standard IFN treatment whereas it is less effective in non-responder patients.
authors.affiliation: Clinic of Infectious Diseases, University of Bari, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Milella
authors.forename: T
authors.initials: T
authors.lastname: Santantonio
authors.forename: G
authors.initials: G
authors.lastname: Pietromatera
authors.forename: R
authors.initials: R
authors.lastname: Maselli
authors.forename: C
authors.initials: C
authors.lastname: Casalino
authors.forename: N
authors.initials: N
authors.lastname: Mariano
authors.forename: C
authors.initials: C
authors.lastname: Genchi
authors.forename: G
authors.initials: G
authors.lastname: Pastore
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012254:Ribavirin / Q000008:administration & dosage*; D018709:Statistics, Nonparametric; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D012254:Ribavirin