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

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