Thirty-five of 44 patients (80%) treated with a 4-week lead-in phase of nitazoxanide followed by the addition of peginterferon for 36 weeks experienced a SVR 24 weeks after the end of treatment compared to 50% in the standard of care (SOC, peginterferon alfa-2a plus ribavirin for 48 weeks) historical control group (P = 0.006), 61% in patients receiving a 12-week lead-in with nitazoxanide followed by 36 weeks of nitazoxanide plus peginterferon alfa-2a, and 79% in patients receiving a 12-week lead-in with nitazoxanide followed by 36 weeks of nitazoxanide plus SOC.
Of the 44 patients in the study, 78% (n=40) of patients with HCV genotype 4, 100% (n=3) of patients with HCV genotype 1, and 100% (n=1) of HCV genotype 2, had an SVR with undetectable virus at 24 weeks following end of treatment.
Adverse events reported for these 44 patients were similar to those reported in the STEALTH C-1 trial. Patients treated with nitazoxanide experienced no more side effects than patients who received the SOC therapy. Only one of the 44 patients discontinued therapy due to noncompliance. There were no serious adverse events or discontinuations due to adverse events.
"These data confirm findings of our STEALTH C-1 trial related to safety
and efficacy of nitazoxanide in patients infected with HCV genotype 4, show
that the nitazoxanide lead-in phase prior to standard of care treatment can
be reduced from 12 to 4 weeks, and indicate that ribavirin may not be
needed to maintain SVR," said Emmet B. Keeffe, M.D., Chief Medical Officer
of Romark Laboratories.
-- "Potential Role for Nitazoxanide in Combination with STAT-C Agents
for the Inhibition of HCV Replication Without the Development of
Resistance," Korba, et al. Sunday Nov. 2, 5:30 PM PST (Oral Session
This oral presentation by Brent Korba, Ph.D. of Georgetown University
Medical Center, described preclinical studies demonstr
|SOURCE Romark Laboratories|
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