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

Inclusion criteria

• Adult (male or female), 18 to 65 years of age, with chronic HCV infection
• BMI < 35
• Liver biopsy showing chronic hepatitis with significant fibrosis using Ishak scoring system
• Compensated liver disease; serum bilirubin < 1.5 mg/dl, INR (international normalized ratio) no more than 1.5, serum albumin > 3.4, platelet count > 75,000 mm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites)
• Acceptable hematological and biochemical indices (hemoglobin 13g/dl for men and 12 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine < 1.5 mg/dl
• Patients must be serum hepatitis B surface antigen (HBsAg) negative
• Negative Antinuclear Antibodies (ANA) or titer of < 1:160
• Serum positive for anti-HCV antibodies and HCV-RNA
• Abdominal Ultrasound obtained within 3 months prior to entry in the study
• Electrocardiogram for men aged > 40 years and for women aged > 50 years
• Normal fundus examination
• Ensure strict measures to avoid conception for both male and female participants by using a proper contraception measure all throughout the course of treatment and six months later
• Female patients must not breast feed during therapy

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