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Romark Announces Presentation of New Data for Nitazoxanide in Chronic Hepatitis C at EASL 2008
Date:4/22/2008

due to

noncompliance. There were no serious adverse events or

discontinuations due to adverse events.

"These data show that the nitazoxanide lead-in phase prior to standard of care treatment can be reduced from 12 to 4 weeks with no apparent impact on virologic response rates," said Jean-Francois Rossignol, M.D., Director of the Romark Institute for Medical Research and lead author of the study.

-- Data from a poster presentation, "Randomized, Double-Blind Placebo-

Controlled Trial of Nitazoxanide in the Treatment of Patients with

Chronic Hepatitis C Genotype 4" showed that nitazoxanide monotherapy

for 24 weeks did not produce adverse events significantly different

from that of a placebo and suggest that monotherapy with nitazoxanide

may be effective in achieving SVR in a limited subset of patients with

low viral load.

In this randomized, controlled study, 50 treatment-nave patients with

chronic hepatitis C genotype 4 were randomized to receive one

nitazoxanide 500 mg tablet or a matching placebo tablet twice daily for

24 weeks. Baseline viral loads and other disease characteristics were

similar between groups. Seven of 23 patients (34%) receiving

nitazoxanide monotherapy achieved undetectable serum HCV RNA after 24

weeks of therapy, compared with 0 of 24 patients receiving placebo

(P=0.004). Four of these 7 treatment responders (4/23, or 17%) had a

SVR 24 weeks after completion of therapy. Patients not achieving

undetectable HCV RNA did not show significant reductions in viral load

or alanine aminotransferase (ALT) levels. Patients responding to

nitazoxanide treatment had lower viral loads at baseline. Adverse

events were typically mild to moderate and occurred with similar

frequency and severity between the nitazoxanide and placebo groups. <
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SOURCE Romark Laboratories
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