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Clinical trial: randomized, double‐blind, placebo‐controlled study of nitazoxanide monotherapy for the treatment of patients with chronic hepatitis C genotype 4
Author(s) -
ROSSIGNOL J. F.,
KABIL S. M.,
ELGOHARY Y.,
ELFERT A.,
KEEFFE E. B.
Publication year - 2008
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2008.03781.x
Subject(s) - nitazoxanide , medicine , placebo , gastroenterology , randomized controlled trial , hepatitis c virus , adverse effect , hepatitis c , immunology , virus , pathology , alternative medicine
Summary Background Nitazoxanide, licensed in the US for treatment of Cryptosporidium parvum and Giardia lamblia , inhibits hepatitis C virus replication in replicon systems. Aim To evaluate the safety and efficacy of nitazoxanide monotherapy for the treatment of chronic hepatitis C. Methods This multicentre, randomized, double‐blind, placebo‐controlled study randomized 50 adult patients with chronic hepatitis C genotype 4 at three centres in Egypt to nitazoxanide 500 mg tablet or placebo twice daily for 24 weeks. Patients were followed up every 4 weeks during treatment and for 24 weeks after therapy. Results Seven of 23 patients (30.4%) in the nitazoxanide group achieved undetectable serum HCV RNA compared to 0 of 24 in the placebo group during therapy ( P = 0.004). Each of the seven responders had baseline HCV RNA levels ≤400 000 IU/mL. Six of the seven virological responders were followed up for 24 weeks after the end of treatment, and four patients (17.4% of 23 treated) had a sustained virological response. Adverse events were similar in the nitazoxanide and placebo groups. Conclusion Nitazoxanide monotherapy is safe and effective in achieving sustained virological response in a modest number of patients with chronic hepatitis C genotype 4, particularly in patients with low baseline serum HCV RNA levels.