Antioxidant therapy for chronic hepatitis C after failure of interferon: results of phase II randomized, double-blind placebo controlled clinical trial.
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.
Gabbay
Ezra
E
Liver Unit, Department of Medicine, Hebrew University, Hadassah Medical Center, POB 12000, Jerusalem IL-91120, Israel.
Zigmond
Ehud
E
Pappo
Orit
O
Hemed
Nila
N
Rowe
Mina
M
Zabrecky
George
G
Cohen
Robert
R
Ilan
Yaron
Y
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
D000975:Antioxidants; D012367:RNA, Viral; D007372:Interferons; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase