Clinical trial: randomized, double-blind, placebo-controlled study of nitazoxanide monotherapy for the treatment of patients with chronic hepatitis C genotype 4.

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 < or =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.

• Authors: J F Rossignol, S M Kabil, Y El-Gohary, A Elfert, E B Keeffe
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 28 Issue 5 Pg. 574-80 (Sep 01 2008) ISSN: 1365-2036 [Electronic] England
• PMID: 18616643 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• Nitro Compounds
• RNA, Viral
• Tablets
• Thiazoles
• nitazoxanide

Topics

• Adult
• Aged
• Antiviral Agents (administration & dosage, adverse effects)
• Double-Blind Method
• Egypt
• Female
• Genotype
• Hepatitis C, Chronic (drug therapy, genetics)
• Humans
• Male
• Middle Aged
• Nitro Compounds
• RNA, Viral (drug effects, physiology)
• Risk Factors
• Tablets
• Thiazoles (administration & dosage, adverse effects)
• Treatment Outcome