Viral Hepatitis
Copyright ©2007 Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Oct 28, 2007; 13(40): 5317-5323
Published online Oct 28, 2007. doi: 10.3748/wjg.v13.i40.5317
Antioxidant therapy for chronic hepatitis C after failure of interferon: Results of phase II randomized, double-blind placebo controlled clinical trial
Ezra Gabbay, Ehud Zigmond, Orit Pappo, Nila Hemed, Mina Rowe, George Zabrecky, Robert Cohen, Yaron Ilan
Ezra Gabbay, Ehud Zigmond, Nila Hemed, Mina Rowe, Yaron Ilan, Orit Pappo, Liver Unit, Department of Medicine; Department of Pathology, Hebrew University, Hadassah Medical Center, Jerusalem IL-91120, Israel
George Zabrecky, Robert Cohen, Marcus Foundation, Atlanta, United States
Author contributions: All authors contributed equally to the work.
Supported by The Bernie Markus Foundation
Correspondence to: Yaron Ilan, MD, Liver Unit, Department of Medicine, Hebrew University, Hadassah Medical Center, POB 12000, Jerusalem IL-91120, Israel. deborah@hadassah.org.il
Telephone: +972-2-6778231 Fax: +972-2-6431021
Received: December 14, 2006
Revised: August 17, 2007
Accepted: September 14, 2007
Published online: October 28, 2007
Abstract

AIM: 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.

CONCLUSION: 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.

Keywords: Hepatitis C virus; Antioxidant therapy; Histology activity index; Glycyrrhiza; L-glutathione