Romark announced results from its Phase 2 trial of nitazoxanide in treatment-naive patients with genotype 1 chronic hepatitis C. This study, named STEALTH C-3, was a randomized, double-blind, placebo controlled trial conducted at thirteen centers in the United States in patients with genotype 1 chronic hepatitis C, 35% of whom had advanced stage 3 or 4 fibrosis.
A sustained virologic response (undetectable HCV RNA) twelve weeks after the end of treatment (SVR12) occurred in 44% of patients treated with nitazoxanide (500 mg twice daily) plus standard therapy (Pegasys and Copegus, from Roche) for 48 weeks versus 32% of patients treated with placebo plus standard therapy. SVR12 rates were consistently higher in subsets of patients with high baseline viral load (41% vs. 29%) and in African Americans (38% vs. 20%).
Nitazoxanide is the first of a new class of broad spectrum antiviral drugs called the thiazolides. It is a potent inhibitor of hepatitis C virus (HCV) in replicon studies. Nitazoxanide has demonstrated that it does not induce viral mutations that confer drug resistance. Additionally, it is synergistic with interferon and direct acting antivirals.
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