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Alinia and Hep C

Dr. Weeks Comment:   Dogs get wormed periodically, why not you?

Alinia / Nitazoxanide / Daxon is a potent and well-tolerated anti-parasite, anti-fungal agent which is used for a great variety of chronic illnesses such as Lymes disease but now the research is in re it use for the treatment of Hep C.

Hepatitis C: little-recognized nitazoxanide (Alinia, Romark) shows remarkable activity in combination therapy for HCV genotype 4

January 17, 2008

Summary

A phase 2 study in Egypt of hepatitis C genotype 4 showed that the viral cure or SVR rate (here actually SVR12 = %HCV RNA negative at post-Rx week 12, real SVR is at week 24) is much improved when nitazoxanide is added to standard therapy.  SVR12 was 79% in nitazoxanide + Pegasys + ribavirin vs. 43% in Pegasys + ribavirin (standard of care).  In prior non-responders to PEG-IFN + ribavirin, the SVR12 rates were 25% for triple therapy and 8% for standard dual therapy (Pegasys + RBV).

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Analysis

Until now, nitazoxanide has received little attention among new therapies for hepatitis C, largely because few preliminary data were available.  Nitazoxanide is currently licensed in the US for treatment of diarrhea caused by one of two parasitic diseases, Gardia lamblia and cryptosporidiosis.  In preliminary trials, nitazoxanide has also shown activity against Clostridium difficile-related colitis.  The mechanism of action against HCV as well as the parasites and the bacterium C. difficile is unknown.  However, it seems unlikely that nitazoxanide is an inhibitor of a specific HCV viral enzyme as it covers a broad range of unrelated organisms.  It will be interesting to see what implications this has on the development of HCV resistance to nitazoxanide.
Data on nitazoxanide monotherapy are sparse.  In a press release on 10-Jan-06, Romark announced that in a placebo-controlled trial of the first 20 patients with HCV GT-4, 50% (5/10) on nitazoxanide had undetectable HCV RNA at week 24 vs. 0% (0/10) on placebo.
This compound has the potential to significantly improve viral cure rates of HCV.  Nitazoxanide now needs to be tested against other genotypes of HCV (1, 2, and 3) that are more prevalent in the US.

AND

Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States

[Outline] ofHepatitis C) development program is being directed in collaboration…Nitazoxanide is the first of a new class of small molecule drugs calle…Stephen A. Harrison M.D. Chief of Hepatology at Brooke Army Medical…STEALTH C Clinical Development Program …The US and international clinical trials described above comprise part…

of Hepatitis C) development program is being directed in collaboration with the Division of Gastroenterology and Hepatology at Stanford University School of Medicine by Emmet B. Keeffe, M.D., Jeffrey S. Glenn, M.D., Ph.D. and Dr. Rossignol who is also a Stanford affiliate.Nitazoxanide is the first of a new class of small molecule drugs called the thiazolides that target cell signaling pathways used in viral replication. Data related to the in vitro activity of nitazoxanide against virus replication in hepatitis C virus (HCV) replicons was presented earlier this year at the 20th International Conference on Antiviral Research.

Stephen A. Harrison, M.D., Chief of Hepatology at Brooke Army Medical Center in Fort Sam Houston, Texas, said, “The potential for use of nitazoxanide in the treatment of chronic hepatitis C is exciting. To better optimize treatment outcomes for patients, we need new antiviral drugs that can be used safely and effectively in combination with existing drugs or with other new drugs in development.”

STEALTH C Clinical Development Program

The US and international clinical trials described above comprise part of the company’s STEALTH C (Studies to Evaluate Alinia for Treatment of Hepatitis C) clinical development program, a series of clinical trials designed to evaluate the safety and efficacy of Alinia tablets in combination with peginterferon or peginterferon and ribavirin in patients with chronic hepatitis C.

The STEALTH C-1 trial, conducted in Egypt in interferon-experienced and naive patients with chronic hepatitis C genotype 4, is a phase II randomized controlled trial evaluating the effectiveness and safety of three treatment regimens: (i) Alinia administered 500 mg twice daily for 12 weeks followed by Alinia-Pegasys combination therapy for 36 weeks, (ii) Alinia 12 weeks followed by Alinia-Pegasys-Copegus combination therapy for 36 weeks and (iii) Pegasys- Copegus combination therapy for 48 weeks (standard of care
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Filed in: Ask Your Doctor About, Hepatitis C, Immune Enhancement, Infectious Disease, Neurology

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