title: Nitazoxanide plus pegylated interferon and ribavirin in the treatment of genotype 4 chronic hepatitis C, a randomized controlled trial.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  The addition of nitazoxanide to pegylated interferon and ribavirin does not improve the virological or biochemical response rates in chronic HCV genotype 4.
authors.affiliation: Division of Gastroenterology and Hepatology, Endemic Medicine Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
authors.forename: Hany M
authors.initials: HM
authors.lastname: Shehab
authors.forename: Tamer M
authors.initials: TM
authors.lastname: Elbaz
authors.forename: Dalia M
authors.initials: DM
authors.lastname: Deraz
mesh_terms: D004359:Drug Therapy, Combination; D004534:Egypt; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D016015:Logistic Models; D009574:Nitro Compounds; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D013844:Thiazoles / Q000627:therapeutic use*
chemical_list: D016898:Interferon-alpha; D009574:Nitro Compounds; D012367:RNA, Viral; D011994:Recombinant Proteins; D013844:Thiazoles; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a; C041747:nitazoxanide