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.
|SOURCE Romark Laboratories|
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