This phase II randomized, controlled trial was conducted at two centers in Egypt and is part of the company’s STEALTH C (studies to evaluate Alinia for treatment of hepatitis C) clinical development program, which is designed to evaluate the safety and efficacy of nitazoxanide tablets in combination with peginterferon or peginterferon and ribavirin (standard of care) in patients with chronic hepatitis C.
In the trial, 96 treatment-naive patients with chronic hepatitis C genotype 4 were randomized into three groups to receive either 48 weeks of standard of care treatment (n=40), 12 weeks of nitazoxanide followed by 36 weeks of nitazoxanide plus peginterferon (a dual regimen, n=28), or 12 weeks of nitazoxanide followed by 36 weeks of nitazoxanide plus standard of care treatment (a triple regimen, n=28). Patients received 180 microgram injections of pegylated interferon once per week. Nitazoxanide was administered as one 500 mg tablet twice daily; and ribavirin was administered as 1,000 or 1,200 mg daily according to weight.
At 12 weeks following the end of treatment, naive patients who received a triple regimen that included standard of care and nitazoxanide showed a significantly higher sustained virologic response (SVR) than the group receiving the standard of care regimen (p=0.006). The data also suggest a potential for eliminating or reducing the role of ribavirin in treating hepatitis C. Patients treated with a dual regimen of nitazoxanide and peginterferon showed an SVR at week 12 following the end of treatment that was not inferior to standard of care (68% vs. 43%, respectively). Of 24 treatment-experienced patients, the triple regimen (n=12) resulted in an SVR of 25% at week 12 post- treatment, and the dual regimen group (n=12) had an SVR of 8%. The patients treated with nitazoxanide also experienced no relapse and no more side effects than patients who received the standard of care.
Nitazoxanide is the first of a new class of small molecule drugs called thiazolides that inhibit replication of a broad range of viruses. Romark is currently conducting a US phase II trial with nitazoxanide plus standard of care in patients with hepatitis C genotype 1 who were previously treated with interferon. The company also plans to initiate a phase II trial in treatment naive patients early in 2008.
Jean-Francois Rossignol, director of the Romark Institute for Medical Research, said: “Results from this trial validate a new approach to treating HCV that focuses on the interaction between the virus and the cell. With confirmation provided by this data we are aggressively pursuing development of nitazoxanide and related drugs to treat chronic hepatitis C and other viral diseases.”