title: Impact of nitazoxanide on sustained virologic response in Egyptian patients with chronic hepatitis C genotype 4: a double-blind placebo-controlled trial.
abstract: BACKGROUND
  Nitazoxanide, approved for the treatment of Cryptosporidium parvum and Giardia lamblia, was found to inhibit hepatitis C virus replication.
  
  
  OBJECTIVE
  The aim of this study was to assess the impact of nitazoxanide as an add-on therapy to pegylated interferon α-2a and ribavirin on sustained virologic response (SVR) in patients with chronic hepatitis C.
  
  
  METHODS
  A total of 200 patients with chronic hepatitis C were enrolled in the study, assigned randomly in a 1 : 1 ratio to two groups: group A (placebo group) and group B (nitazoxanide group). Five patients withdrew from the study after they signed the consent form.A total of 195 patients were evaluated: 97 patients in group A versus 98 patients in group B at a dose of 500 mg twice daily. Placebo and nitazoxanide were administered as an add-on therapy to pegylated interferon α-2a plus ribavirin following a 12-week lead-in phase. SVR was evaluated. Statistical analysis was carried out using the SPSS software.
  
  
  RESULTS
  The mean age of the patients in group A was 46.5 versus 45.7 years in group B. In group A, 85 out of 97 (87.6%) patients were men and in group B, 84 out of 98 (85.7%) patients were men.In group A, 59 out of 97 (60.82%) patients achieved an SVR versus 57 out of 98 (58.16%) patients in group B (P=0.70); this difference was not significant.
  
  
  CONCLUSIONS
  Our data did not show any significant impact of nitazoxanide on SVR.
authors.affiliation: Departments of aHepatology bClinical Biochemistry cPathology dEpidemiology, National Liver Institute, Menoufiya University, Menoufiya, Egypt.
authors.forename: Mohamed A S
authors.initials: MA
authors.lastname: Kohla
authors.forename: Hala
authors.initials: H
authors.lastname: El-Said
authors.forename: Ashraf
authors.initials: A
authors.lastname: El-Fert
authors.forename: Nermine
authors.initials: N
authors.lastname: Ehsan
authors.forename: Sameera
authors.initials: S
authors.lastname: Ezzat
authors.forename: Hossam
authors.initials: H
authors.lastname: Taha
mesh_terms: D000328:Adult; D000977:Antiparasitic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004534:Egypt; D005260:Female; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009574:Nitro Compounds; D011092:Polyethylene Glycols / Q000627:therapeutic use; D012367:RNA, Viral / Q000097:blood*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use; D013844:Thiazoles / Q000009:adverse effects / Q000627:therapeutic use*; D019562:Viral Load
chemical_list: D000977:Antiparasitic Agents; D000998:Antiviral Agents; 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