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Study Showing Improved Virologic Response with Nitazoxanide in Chronic Hepatitis C Published in Gastroenterology
Date:3/2/2009

ide plus peginterferon for an additional 36 weeks (n = 28);
  • Nitazoxanide monotherapy for 12 weeks followed by nitazoxanide plus both peginterferon and ribavirin for 36 weeks (n = 28).
  • The primary endpoint was sustained virological response (SVR), or serum HCV RNA <12 IU/mL 24 weeks after the end of treatment. Secondary endpoints included HCV RNA <12 IU/mL at week 4 (rapid virological response, or RVR), at week 12 (complete early virological response, cEVR), and at the end-of-treatment (ETR).

    Results

    The percentages of patients with RVR, defined as undetectable serum 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% versus 38%, p=0.048 and 79% versus 50%, p=0.023, 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 a higher rate of anemia in the groups receiving ribavirin. In the nitazoxanide group, virologic responses were maintained through the end of treatment with no virologic breakthroughs. Of note, the use of nitazoxanide was associated with reduced relapse rates (3/20 patients in the peginterferon plus nitazoxanide arm, and 1/23 patients in the triple arm with peginterferon, ribavirin and nitazoxanide) versus 10/30 patients in the standard-of-care arm.

    About Nitazoxanide and Hepatitis C

    Nitazoxanide, the first of a new class of broad spectrum antiviral drugs known as the thiazolides, is undergoing worldwide development as a treatment of chronic hepatitis C. Nitazoxanide is a potent inhibitor of hepatitis C virus (HCV) replication in HCV genotype 1-derived replicon cell lines, and in vitro studies have shown that it does not induce mutations in the virus that confer resistance. Phase II clinical trials
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    SOURCE Romark Laboratories
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