Treatment of Chronic Hepatitis C Using a 4-week Lead-in... : Journal of Clinical Gastroenterology (original) (raw)

LIVER, PANCREAS AND BILIARY TRACT: Original Articles

Treatment of Chronic Hepatitis C Using a 4-week Lead-in With Nitazoxanide Before Peginterferon Plus Nitazoxanide

Rossignol, Jean-Francois MD, PhD* †; Elfert, Asem MD‡; Keeffe, Emmet B. MD* †

*The Romark Institute for Medical Research, Tampa, FL

†Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University Medical Center, Stanford, CA

‡Department of Gastroenterology and Hepatology, Faculty of Medicine, University of Tanta, Tanta, Egypt

Dr Elfert received grant support from Romark for the conduct of this study.

Reprints: Emmet B. Keeffe, MD, Romark Laboratories, L.C., 2320 Marinship Way, Suite 250, Sausalito, CA 94965-2812 (e-mail: [email protected]).

Received for publication June 5, 2009

accepted September 2, 2009

Conflict of Interest Disclosures: Dr Rossignol is an employee of, and owns an equity interest in, Romark Laboratories, and Dr Keeffe is an employee of Romark Laboratories. The data analyses and writing of the paper were carried out by Drs Rossignol and Keeffe.

Abstract

Goals

The primary aim of this study was to further evaluate the efficacy of peginterferon plus nitazoxanide without ribavirin using a 4-week lead-in.

Background

The initial treatment of chronic hepatitis C with nitazoxanide used 12 weeks of nitazoxanide monotherapy before combination therapy with peginterferon with or without ribavirin.

Study

This open-label pilot study enrolled 44 treatment-naive patients with chronic hepatitis C (40 with genotype 4; 3 with genotype 1; and 1 with genotype 2). The patients received oral nitazoxanide 500 mg twice daily for 4 weeks followed by nitazoxanide plus peginterferon alfa-2a 180 μg weekly for 36 weeks and were then followed for 24 weeks. The results of this study were compared with those from an overlapping historical trial using 12 weeks of nitazoxanide lead-in.

Results

A sustained virologic response (SVR) was achieved in 80% of patients, which was similar to the SVR rates in the historical trial, that is, 79% and 61% in patients treated with and without ribavirin, respectively. A rapid virologic response occurred in 59% of patients, which was also similar to the rapid virologic response rates in the historical trial (64% and 54% in patients treated with and without ribavirin, respectively). All 4 patients with genotypes 1 and 2 had an SVR.

Conclusions

The nitazoxanide lead-in phase before combination therapy with peginterferon can likely be reduced from 12 weeks to 4 weeks without compromising virologic response rates. In addition, treatment of chronic hepatitis C with peginterferon plus nitazoxanide without ribavirin is promising and requires further study.