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Treatment of Chronic Hepatitis C Virus Infection via Antioxidants: Results of a Phase I Clinical Trial

Melhem, Alla MD*; Stern, Mirela MD*; Shibolet, Oren MD*; Israeli, Eran MD*; Ackerman, Zvi MD*; Pappo, Orit MD; Hemed, Nilla RN*; Rowe, Mina RN*; Ohana, Hana RN*; Zabrecky, George MD; Cohen, Robert MD; Ilan, Yaron MD*

Journal of Clinical Gastroenterology: September 2005 - Volume 39 - Issue 8 - p 737-742
doi: 10.1097/01.mcg.0000174023.73472.29
Liver, Pancreas, and Biliary Tract: Clinical Research

Background: The pathogenesis of chronic hepatitis C virus (HCV) infection is associated with a defective host antiviral immune response and intrahepatic oxidative stress. Oxidative stress and lipid peroxidation play major roles in the fatty liver accumulation (steatosis) that leads to necro-inflammation and necrosis of hepatic cells. Previous trials suggested that antioxidative therapy may have a beneficial effect on patients with chronic HCV infection.

Aims: To determine the safety and efficacy of treatment of chronic HCV patients via a combination of antioxidants.

Methods: Fifty chronic HCV patients were treated orally on a daily basis for 20 weeks with seven antioxidative oral preparations (glycyrrhizin, schisandra, silymarin, ascorbic acid, lipoic acid, L-glutathione, and alpha-tocopherol), along with four different intravenous preparations (glycyrrhizin, ascorbic acid, L-glutathione, B-complex) twice weekly for the first 10 weeks, and followed up for an additional 20 weeks. Patients were monitored for HCV-RNA levels, liver enzymes, and liver histology. Assessment of quality of life was performed using the SF-36 questionnaire.

Results: In one of the tested parameters (eg, liver enzymes, HCV RNA levels, or liver biopsy score), a combination of antioxidants induced a favorable response in 48% of the patients (24). Normalization of liver enzymes occurred in 44% of patients who had elevated pretreatment ALT levels (15 of 34). ALT levels remained normal throughout follow-up period in 72.7% (8 of 11). A decrease in viral load (one log or more) was observed in 25% of the patients (12). Histologic improvement (2-point reduction in the HAI score) was noted in 36.1% of the patients. The SF-36 score improved in 26 of 45 patients throughout the course of the trial (58% of the patients). Treatment was well tolerated by all patients. No major adverse reactions were noted.

Conclusions: These data suggest that multi antioxidative treatment in chronic HCV patients is well tolerated and may have a beneficial effect on necro-inflammatory variables. A combination of antiviral and antioxidative therapies may enhance the overall response rate of these patients.

From the *Liver Unit, Department of Medicine, and †Department of Pathology, Hebrew University, Hadassah Medical Center, Jerusalem, Israel; and ‡Marcus Foundation, Atlanta, GA.

Received for publication November 30, 2004; accepted April 26, 2005.

Supported by a grant from the Marcus Foundation, Atlanta, GA.

Reprints: Yaron Ilan, MD, Liver Unit, Department of Medicine, Hadassah University Hospital, P.O.B. 12000, Jerusalem, Israel 91120 (e-mail: ilan@hadassah.org.il).

© 2005 Lippincott Williams & Wilkins, Inc.