title: A pilot study of combination therapy with ribavirin plus interferon alfa for interferon alfa-resistant chronic hepatitis C.
abstract: OBJECTIVE
  In chronic hepatitis C, interferon alfa (IFN-alpha) therapy fails to achieve a sustained response in approximately 75% of patients. Similarly, ribavirin induces only a transient response. The aim of this study was to evaluate whether ribavirin and IFN-alpha in combination could be effective in IFN-alpha-resistant chronic hepatitis C.
  
  
  METHODS
  Twenty patients with chronic hepatitis C resistant to a previous course of IFN-alpha were randomly assigned to receive either ribavirin combined with IFN-alpha or IFN-alpha alone for 6 months.
  
  
  RESULTS
  Serum alanine aminotransferase levels decreased significantly during therapy in both treatment groups, but after therapy, the levels remained significantly decreased only in the combination therapy group. Nine months after treatment, sustained normalization of aminotransferase levels, associated with sustained loss of serum hepatitis C virus RNA, was observed in 40% of the patients in the combination therapy group but in none of the patients treated with IFN-alpha alone (P < 0.05). The sustained response was accompanied by reduced hepatic necroinflammatory activity on biopsy.
  
  
  CONCLUSIONS
  These findings suggest that ribavirin plus IFN-alpha combination therapy is able to induce a sustained biochemical and virological response in a significant proportion of patients with IFN-alpha-resistant chronic hepatitis C.
authors.affiliation: Department of Internal Medicine and Gastroenterology, University of Bologna, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Brillanti
authors.forename: J
authors.initials: J
authors.lastname: Garson
authors.forename: M
authors.initials: M
authors.lastname: Foli
authors.forename: K
authors.initials: K
authors.lastname: Whitby
authors.forename: R
authors.initials: R
authors.lastname: Deaville
authors.forename: C
authors.initials: C
authors.lastname: Masci
authors.forename: M
authors.initials: M
authors.lastname: Miglioli
authors.forename: L
authors.initials: L
authors.lastname: Barbara
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D002908:Chronic Disease; D004352:Drug Resistance, Microbial; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000235:genetics; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012313:RNA / Q000097:blood; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D016898:Interferon-alpha; D012254:Ribavirin; D012313:RNA; D000410:Alanine Transaminase