nitazoxanide plus peginterferon. The STEALTH C-1(2) trial used 12
weeks of lead-in therapy with nitazoxanide alone. This clinical study
was designed to evaluate the effect of reducing the lead-in phase from
12 weeks to 4 weeks.
In this Phase II study, 44 patients (40 with HCV genotype 4; 3 with HCV
genotype 1; and 1 with HCV genotype 2) received 4 weeks of nitazoxanide
500 mg twice daily followed by Pegasys(R) (peginterferon alfa-2a) and
nitazoxanide for 36 weeks. Romark's STEALTH C-1 trial (see description
above) was used as an historical control, where randomized patients
were treated for 12 weeks with nitazoxanide before adding SOC treatment.
Analysis of data was by intention to treat.
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 12 weeks after the end of treatment (SVR12) compared
to 50% in the SOC historical control group (P = 0.004), 61% in patients
receiving a 12-week lead-in with nitazoxanide followed by 36 weeks of
nitazoxanide plus peginterferon, and 79% in patients receiving a 12-
week lead-in with nitazoxanide followed by 36 weeks of nitazoxanide
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 undetectable virus at 12 weeks following end of
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
|SOURCE Romark Laboratories|
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