Study Showing Improved Virologic Response with Nitazoxanide in Chronic Hepatitis C Published in Gastro... ( Editorial Accompanies Manuscript in M...)

Study Showing Improved Virologic Response with Nitazoxanide in Chronic Hepatitis C Published in Gastroenterology

Date:3/2/2009

Editorial Accompanies Manuscript in March Issue

TAMPA, Fla., March 2 /PRNewswire/ -- A study evaluating nitazoxanide in combination with peginterferon alfa-2a and ribavirin in patients with chronic hepatitis C virus (HCV) infection with genotype 4 was published in the March issue of Gastroenterology, the official journal of the American Gastroenterological Association Institute (AGA Institute). The study showed that the addition of nitazoxanide to standard-of-care therapy increased the rate of sustained virologic response when compared with patients given peginterferon plus ribavirin alone.(1) An accompanying editorial commenting on the study was also published in the Journal.(2)

"The results published today in Gastroenterology represent an important milestone in the development of nitazoxanide, the first thiazolide, for the treatment of chronic hepatitis C," said Jean-Francois Rossignol, MD, PhD, Romark Institute for Medical Research, the inventor of this new class of antiviral drugs and lead author of the study. "Nitazoxanide is currently being evaluated along with the standard-of-care treatment in patients with chronic hepatitis C genotype 1 in clinical trials in the U.S., and we look forward to reporting interim data from those trials in the coming months."

Study Details

The randomized, controlled study published in Gastroenterology evaluated the safety and efficacy of nitazoxanide plus peginterferon, with or without ribavirin, in 97 patients with previously untreated genotype 4 chronic hepatitis C at 2 centers in Egypt. Participants were sequentially allocated into 3 treatment arms (one patient immediately dropped from the study):

Peginterferon alfa-2a 180 mcg/week plus ribavirin 1000-1200 mg/day for 48 weeks (standard of care) (n = 40);
Nitazoxanide 500 mg twice daily monotherapy for 12 weeks followed by nitazoxan
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