Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C
Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C
The purpose of this study is to evaluate the safety and efficacy of
 nitazoxanide-peginterferon and nitazoxanide-peginterferon-ribavirin combination regimens
 compared to the standard of care (peginterferon-ribavirin) in treating chronic hepatitis C
 genotype 4. The study will also evaluate the effect of the studied treatment regimens on end
 of treatment virologic response, ALT normalization and safety parameters.
Inclusion Criteria:

 -  Age ≥18 years.

 -  Chronic hepatitis C infection (at least 6 months) evidenced by a positive enzyme
 immunoassay for anti-HCV-antibodies and a positive quantitative RT-PCR amplification
 of HCV RNA.

 -  Chronic inflammation on liver biopsy compatible with a diagnosis of chronic viral
 hepatitis.

 -  HCV genotype 4.

 Exclusion Criteria:

 -  Patients who have previously failed to respond to ≥12 weeks of peginterferon-ribavirin
 combination therapy.

 -  Females who are either pregnant, breast-feeding or not using birth control and are
 sexually active.

 -  Males whose female partners are pregnant.

 -  Patients with other causes of liver disease (i.e., autoimmune hepatitis, decompensated
 liver disease).

 -  Patients co-infected with hepatitis A virus, hepatitis B virus or hepatitis D virus.

 -  Patients with a history of alcoholism or with an alcohol consumption of >40 grams per
 day.

 -  Patients with hemoglobinopathies (i.e., thalassemia major, sickle-cell anemia).

 -  Patients with any concomitant condition that, in the opinion of the investigator,
 would preclude evaluation of response or make it unlikely that the contemplated course
 of therapy and follow-up could be completed.

 -  History of hypersensitivity or intolerance to any of the excipients comprising the
 nitazoxanide tablets, peginterferon alfa-2a injectionable solution or ribavirin
 tablets.