receive 12 weeks of nitazoxanide followed by either the dual regimen
(n=12) or the triple regimen (n=12) for 36 weeks. Patients received
peginterferon alfa-2a (Pegasys(R), Hoffman LaRoche) 180 micrograms once
per week; nitazoxanide was administered as one 500 mg tablet twice
daily; and ribavirin (Copegus(R), Hoffman LaRoche) was administered as
1,000 or 1,200 mg daily according to body weight. Analysis of data was
by intention to treat.
In treatment-naive patients, combination therapy with nitazoxanide plus
SOC resulted in a SVR24 rate of 79%, compared with 50% for those
treated with SOC without nitazoxanide (P=0.023). When nitazoxanide was
combined with peginterferon alone, the observed SVR24 rate in this
group was 61%. In 24 treatment-experienced patients, the addition of
nitazoxanide to SOC for 36 weeks resulted in a 25% rate of SVR,
compared with 8% when nitazoxanide was combined with peginterferon
alone. The patients treated with nitazoxanide experienced no more side
effects than patients who received the SOC.
Interim results of this trial were presented at the 58th Annual Meeting
of the American Association for the Study of Liver Diseases (AASLD) in
-- A poster presentation, titled "Evaluation of a 4-week Lead-in Phase
With Nitazoxanide Prior to Nitazoxanide+Peginterferon in Treating
Chronic Hepatitis C," demonstrated that reducing a nitazoxanide lead-in
phase from 12 to 4 weeks, followed by the addition of SOC therapy, does
not compromise virologic response rates in a patient population with
different genotypes, predominately genotype 4.
Replicon studies and an early clinical experience (unpublished)
indicated that treatment with nitazoxanide alone prior to adding<
|SOURCE Romark Laboratories|
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