Phase 2 study of nitazoxanide for the treatment of genotype 1 chronic hepatitis C

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.

For more information call (813) 282-8544 or visit www.romark.com.