Treatment of chronic hepatitis C using a 4-week lead-in with nitazoxanide before peginterferon plus nitazoxanide.

GOALS

The primary aim of this study was to further evaluate the efficacy of peginterferon plus nitazoxanide without ribavirin using a 4-week lead-in.

BACKGROUND

The initial treatment of chronic hepatitis C with nitazoxanide used 12 weeks of nitazoxanide monotherapy before combination therapy with peginterferon with or without ribavirin.

STUDY

This open-label pilot study enrolled 44 treatment-naive patients with chronic hepatitis C (40 with genotype 4; 3 with genotype 1; and 1 with genotype 2). The patients received oral nitazoxanide 500 mg twice daily for 4 weeks followed by nitazoxanide plus peginterferon alfa-2a 180 mug weekly for 36 weeks and were then followed for 24 weeks. The results of this study were compared with those from an overlapping historical trial using 12 weeks of nitazoxanide lead-in.

RESULTS

A sustained virologic response (SVR) was achieved in 80% of patients, which was similar to the SVR rates in the historical trial, that is, 79% and 61% in patients treated with and without ribavirin, respectively. A rapid virologic response occurred in 59% of patients, which was also similar to the rapid virologic response rates in the historical trial (64% and 54% in patients treated with and without ribavirin, respectively). All 4 patients with genotypes 1 and 2 had an SVR.

CONCLUSIONS

The nitazoxanide lead-in phase before combination therapy with peginterferon can likely be reduced from 12 weeks to 4 weeks without compromising virologic response rates. In addition, treatment of chronic hepatitis C with peginterferon plus nitazoxanide without ribavirin is promising and requires further study.