Chronic hepatitis C has become an endemic disease in Egypt with a rising prevalence (genotype 4), worldwide it also poses a significant health burden. To date standard of care treatment (pegylated interferon and ribavirin) give modest results with a sustained virological response (SVR) of about 50%. Several pharmaceutical and herbal agents have been used with an aim to improve current results. Recent reports have suggested an increased SVR with the addition of Nitazoxanide to standard of care. The results are preliminary and need to be confirmed. This is a randomized trial to assess the efficacy of nitazoxanide added to standard of care compared to standard of care alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Pegylated interferon 160ug once weekly 48 weeks
Nitazoxanide 500mg twice daily 4 weeks lead-in followed by triple therapy 48 weeks
Ribavirin (\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks
Cairo University
Cairo, Egypt
Sustained Virologic Response
sustained virological response is defined as a negative HCV PCR at 180 days after the end of treatment (End of treatment being at 48 weeks for Group A, 52 weeks for Group B). For any patient who stopped treatment prematurely (e.g. due to adverse events) SVR was defined as a negative HCV PCR (polymerase chain reaction) at 180 days after the last dose of all medications (interferon, ribavirin and nitazoxanide)
Time frame: 180 days (+- 7 days) after the end of treatment. (48 weeks for Group A, 52 weeks for Group B, or after the last dose of treatment for patients who stopped prematurely).
Rapid Virological Response
A rapid virologic response is defined as a negative HCV PCR 4 weeks after treatment
Time frame: 28 - 33 days after start of Pegylated interferon and ribavirin
Early Virological Response
A complete early virologic response is defined as a negative HCV PCR 90 days after the start of pegylated interferon. A partial early virologic response is defined as a decrease of 2 or more log in HCV PCR at 90 days after the start of pegylated interferon
Time frame: 90 ± 7 days from the start of pegylated interferon and ribavirin
End-of-treatment Response
An end-of-treatment response is defined as a negative HCV PCR at 48 weeks after the start of pegylated interferon and ribavirin
Time frame: 48 weeks +- 7 days after starting pegylated interferon and ribavirin
Safety of Nitazoxanide (Number of Participants Experiencing Adverse Events)
The occurence of adverse events that could be linked temporally and reasonably to the administration of the tested drug.
Time frame: throughout the period of treatment and up to 90 days after end of triple therapy
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