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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
One oral nitazoxanide 500 mg tablet with food twice daily for 48 weeks.
Weekly injections of 180µg peginterferon alfa-2a for 36 weeks.
Weekly injections of 180 µg peginterferon alfa-2a for 48 weeks.
Department of Tropical Medicine & Infectious Diseases, Alexandria University
Alexandria, Egypt
Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
Tanta, Egypt
Sustained virologic response
Time frame: 24 weeks after the end of treatment
End of treatment virologic response
Time frame: At the end of treatment
Early virologic response
Time frame: After 12 weeks of combination therapy
Rapid virologic response
Time frame: After 4 weeks of combination therapy
ALT normalization
Time frame: 24 weeks after the end of treatment
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Oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 36 weeks.
Oral ribavirin 1000 mg (body weight \<75 kg) or 1200 mg (body weight ≥75 kg) daily in two divided doses for 48 weeks.