title: Antioxidant therapy for chronic hepatitis C after failure of interferon: results of phase II randomized, double-blind placebo controlled clinical trial.
abstract: OBJECTIVE
  To assess the safety and efficacy of antioxidant therapy for patients with chronic hepatitis C virus (HCV) infection.
  
  
  METHODS
  One hundred chronic HCV infection patients failed in interferon treatment were enrolled and randomly assigned to receive combined intravenous and oral antioxidants or placebo, or oral treatment alone. Primary end points were liver enzymes, HCV-RNA levels and histology.
  
  
  RESULTS
  Combined oral and intravenous antioxidant therapy was associated with a significant decline in ALT levels in 52% of patients who received antioxidant therapy vs 20% of patients who received placebo (P = 0.05). Histology activity index (HAI) score at the end of treatment was reduced in 48% of patients who received antioxidant therapy vs 26% of patients who received placebo (P = 0.21). HCV-RNA levels decreased by 1-log or more in 28% of patients who received antioxidant therapy vs 12% who received placebo (P = NS). In part II of the trial, oral administration of antioxidants was not associated with significant alterations in any of the end points.
  
  
  CONCLUSIONS
  Antioxidant therapy has a mild beneficial effect on the inflammatory response of chronic HCV infection patients who are non-responders to interferon. Combined antiviral and antioxidant therapy may be beneficial for these patients.
authors: Liver Unit, Department of Medicine, Hebrew University, Hadassah Medical Center, POB 12000, Jerusalem IL-91120, Israel.
authors: Ezra
authors: E
authors: Gabbay
authors: Ehud
authors: E
authors: Zigmond
authors: Orit
authors: O
authors: Pappo
authors: Nila
authors: N
authors: Hemed
authors: Mina
authors: M
authors: Rowe
authors: George
authors: G
authors: Zabrecky
authors: Robert
authors: R
authors: Cohen
authors: Yaron
authors: Y
authors: Ilan
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000378:metabolism; D000975:Antioxidants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000378:metabolism; D001706:Biopsy; D004311:Double-Blind Method; D005260:Female; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000201:enzymology / Q000473:pathology; D006801:Humans; D007275:Injections, Intravenous; D007372:Interferons; D008099:Liver / Q000201:enzymology / Q000473:pathology; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood
chemical_list: D000975:Antioxidants; D012367:RNA, Viral; D007372:Interferons; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase