Improved Virologic Response in Chronic Hepatitis C Genotype 4 Treated With Nitazoxanide, Peginterferon, and Ribavirin

Received 29 August 2008; accepted 13 November 2008. published online 21 November 2008.

Refers to article:

Nitazoxanide: Beyond Parasites Toward a Novel Agent for Hepatitis C , 23 January 2009
Jama M. Darling, Michael W. Fried
Gastroenterology
March 2009 (Vol. 136, Issue 3, Pages 760-763)
Full Text | Full-Text PDF (404 KB)

Background & Aims

Sustained virologic response (SVR) rates of 50%–60% have been achieved in patients with chronic hepatitis C genotype 4 treated with peginterferon plus ribavirin. The safety and efficacy of nitazoxanide plus peginterferon alfa-2a, with or without ribavirin, were evaluated in a randomized controlled trial at 2 centers in Egypt.

Methods

Previously untreated patients with chronic hepatitis C and genotype 4 infection were assigned randomly to groups that were given standard of care (peginterferon alfa-2a and ribavirin for 48 weeks, n = 40), nitazoxanide monotherapy for 12 weeks followed by nitazoxanide plus peginterferon alfa-2a for 36 weeks (n = 28), or nitazoxanide monotherapy for 12 weeks followed by nitazoxanide plus peginterferon alfa-2a and ribavirin for 36 weeks (n = 28). Therapeutics included nitazoxanide (500 mg) twice daily, peginterferon alfa-2a (180 μg) once weekly, and weight-based ribavirin (1000–1200 mg/day).

Results

The percentages of rapid virologic response (RVR), defined as undetectable HCV RNA at week 4 of combination therapy, and SVR were significantly higher in patients given the triple therapy compared with the standard of care (64% vs 38%, P = .048; and 79% vs 50%, P = .023; respectively). Patients given nitazoxanide plus peginterferon alfa-2a had intermediate rates of RVR (54%) and SVR (61%). Adverse events were similar across treatment groups except for higher rates of anemia in the groups receiving ribavirin.

Conclusions

The combination of nitazoxanide, peginterferon alfa-2a, and ribavirin increased the percentages of patients with RVR and SVR, compared with patients given peginterferon plus ribavirin, without an increase in adverse events.

Abbreviations used in this paper: RVR, rapid virologic response, SVR, sustained virologic response

⁎ The Romark Institute for Medical Research, Tampa, Florida

‡ Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University Medical Center, Stanford, California

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

∥ Department of Tropical Medicine and Infectious Diseases, University of Alexandria, Faculty of Medicine, Alexandria, Egypt

Reprint requests Address requests for reprints to: Emmet B. Keeffe, MD, Romark Laboratories, L.C., 2320 Marinship Way, Suite 250, Sausalito, California 94965. fax: (415) 332-1067

Conflicts of interest The authors disclose the following: Drs Rossignol and Keeffe are employees of Romark Laboratories, L.C., and participated in the design and conduct of this study, data analysis, and creation of this manuscript. Drs Asem Elfert and Yehia El-Gohary received research grant support from Romark Laboratories, L.C., for the conduct of this study and collection of data. This manuscript was written by the authors without independent contract writing assistance.

PII: S0016-5085(08)02051-9

doi:10.1053/j.gastro.2008.11.037

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