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Nitazoxanide plus pegylated interferon and ribavirin in the treatment of genotype 4 chronic hepatitis C, a randomized controlled trial

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Abstract

Background & Aims

Nitazoxanide has been proposed as a novel therapeutic agent for chronic hepatitis C virus (HCV) potentiating the effect of interferon and improving sustained virological response rates to up to 80% in genotype 4. This is an independent randomized trial to confirm the efficacy of nitazoxanide in the treatment of chronic hepatitis C genotype 4.

Methods

This was an open-label trial. Treatment-naive genotype 4 HCV patients were recruited: Group 1 received weekly subcutaneous pegylated interferon 160 μg in addition to weight-based ribavirin (1200 mg if ≥75 kg and 1000 mg if <75 kg) for 48 weeks, Group 2 received 4 weeks lead-in therapy by nitazoxanide alone (500 mg bid) followed by triple therapy including nitazoxanide, pegylated interferon and ribavirin for a further 48 weeks.

Results

Fifty patients were recruited in each group. Baseline characteristics were similar except for a higher BMI in group 1 (28.5 vs. 26.5, P = 0.01). SVR rates were similar (24/50 (48%) vs. 25/50 (50%) in groups 1 and 2 respectively, P: 0.84). RVR, cEVR and ETR rates were also similar (61% vs. 53% – P:0.4, 70% vs. 72% – P:0.8 and 62% vs. 58% – P:0.6 in groups 1 and 2 respectively). Biochemical response at week 12 was also similar (57% vs. 46% in groups 1 and 2 respectively, P:0.26). Complications were similar except for a higher rate of dyspepsia in the group receiving nitazoxanide (32% vs. 14%, P:0.03).

Conclusion

The addition of nitazoxanide to pegylated interferon and ribavirin does not improve the virological or biochemical response rates in chronic HCV genotype 4. (clinicaltrials.gov identifier: NCT01276756).

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