Efficacy of Nitazoxanide in the Treatment of Chronic Hepatitis C Virus (HCV)

Exclusion Criteria

• •Patients who previously received interferon
• •HgbA1c \> 7.5 (glycoslylated haemoglobin)or history of diabetes mellitus
• •BMI \> 34
• •Women who are pregnant or breast-feeding
• •Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active
• •Other causes of liver disease including autoimmune hepatitis
• •Transplant recipients receiving immune suppression therapy
• •Screening tests positive for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab or anti-HIV Ab
• •Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, CTP score \> 6 (Child-Turcot-Pugh) or MELD score \> 8
• •Absolute neutrophil count \< 1500 cells/mm3; platelet count \< 135,000 cells/mm3; hemoglobin \< 12 g/dL for women and \< 13 g/dL for men; or serum creatinine concentration ≥ 1.5 times ULN (upper limit of normal)
• •Hypothyroidism or hyperthyroidism not effectively treated with medication
• •Alcohol consumption of \> 40 grams per day or an alcohol use pattern that will interfere with the study
• •History or other clinical evidence of significant or unstable cardiac disease
• •History or other clinical evidence of chronic pulmonary disease associated with functional impairment
• •Serious or severe bacterial infection(s)
• •History of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization
• •History of uncontrolled severe seizure disorder
• •History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids
• •Patients with clinically significant retinal abnormalities
• •History of hypersensitivity or intolerance to nitazoxanide or any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectable solution or ribavirin tablets