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- Title
Clinical trial: randomized, double-blind, placebo-controlled study of nitazoxanide monotherapy for the treatment of patients with chronic hepatitis C genotype 4.
- Authors
ROSSIGNOL, J. F.; KABIL, S. M.; EL‐GOHARY, Y.; ELFERT, A.; KEEFFE, E. B.
- Abstract
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.
- Subjects
ANTI-infective agents; HEPATITIS C treatment; HEPATITIS viruses; DRUG efficacy; SAFETY; RNA
- Publication
Alimentary Pharmacology & Therapeutics, 2008, Vol 28, Issue 5, p574
- ISSN
0269-2813
- Publication type
Article
- DOI
10.1111/j.1365-2036.2008.03781.x