First geno 1 treated w/ Alinia, very encouraging.

[orleans]

There were 3 geno 1 in this study, all responded. This is part of the Egyptian study that has been going on for the last couple of years.-----------In this Phase II study, 44 patients (40 with HCV genotype 4; 3 with HCV

       genotype 1; and 1 with HCV genotype 2) received 4 weeks of nitazoxanide

       500 mg twice daily followed by Pegasys(R) (peginterferon alfa-2a) and

       nitazoxanide for 36 weeks.  Romark's STEALTH C-1 trial (see description

       above) was used as an historical control, where randomized patients

       were treated for 12 weeks with nitazoxanide before adding SOC treatment.

       Analysis of data was by intention to treat.


       Thirty-five of 44 patients (80%) treated with a 4-week lead-in phase of

       nitazoxanide followed by the addition of peginterferon for 36 weeks

       experienced a SVR 12 weeks after the end of treatment (SVR12) compared

       to 50% in the SOC historical control group (P = 0.004), 61% in patients

       receiving a 12-week lead-in with nitazoxanide followed by 36 weeks of

       nitazoxanide plus peginterferon, and 79% in patients receiving a 12-

       week lead-in with nitazoxanide followed by 36 weeks of nitazoxanide

       plus SOC.


       Of the 44 patients in the study, 78% (n=40) of patients with HCV

       genotype 4, 100% (n=3) of patients with HCV genotype 1, and 100% (n=1)

       of HCV genotype 2, had undetectable virus at 12 weeks following end of

       treatment.


here's a link  http://www.hepcaustralia.com.au/index.php/component/content/article/24-latest-news/611-romark-announces-presentation-of-new-data-for-nitazoxanide-in-chronic-hepatitis-c-at-easl-2008

[orleans]

Hey, It is amazing how quite this company has been. They are not publicly traded is likely the reason. No need for hype here. As far as cost goes 500mg tabs in the us run about $16(I think!) Nitazoxnide can be purchased in Canada for less than $4 ea. Licenced by Romark but manufactured in India by Cipla, a reputable, traded  company as far as I can tell. Really couldn't find that much on them, a good thing I guess. And YES, I would love to try a foursome, Alinia/INF/RIBA/TLP(950) jm

[moahunter]

Wow - if this is as good as suggested, it could become the "gold standard". Not good news for other drugs in the pipeline though, which will be more expensive than Alina, and may have additional side effects. If Alina works, the gold standard could shift before newer drugs are approved, resulting in more trials for the new drugs (to try cominiations wit Alina to see if more effective than it).

[orleans]

The above study is a little newer than yhis one. This one was prsented this past Nov. in Boston.(The liverheads have a BIG conference there each Nov., the "AASLD")                       Andiamo1
Male, 68 years
FL
Member since Jun 2007
Mood: Andiamo1 is feeling more relaxed
  



, Nov 02, 2007 09:19AM
Romark Laboratories, a privately-owned biotechnology company, today announced results of a randomized phase II clinical trial showing that 79% of interferon-naïve patients with chronic hepatitis C genotype 4 receiving nitazoxanide plus the standard of care had a sustained virologic response (SVR), or undetectable level of virus, 12 weeks following treatment, compared to 43% of patients receiving the standard of care without nitazoxanide. The patients treated with nitazoxanide also experienced no relapse and no more side effects than patients who received the standard of care. Interim results from this Phase II clinical trial will be presented on Tuesday November 6 in an oral presentation at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.

"Patients treated with nitazoxanide responded earlier and maintained their responses without relapse after receiving only 36 weeks of treatment with peginterferon and ribavirin," said Dr. Emmet B. Keeffe, Chief of Hepatology at Stanford University School of Medicine. "These data suggest the emergence of a new therapeutic approach for treating hepatitis C. While more study is needed to confirm these results in a broader population of patients, nitazoxanide appears to increase the potency of interferon without increasing toxicity or inducing resistance."

Study Details
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). An additional 24 interferon-experienced patients were randomized to receive 12 weeks of nitazoxanide followed by either the dual regimen (n=12) or the triple regimen (n=12) for 36 weeks. Patients received 180 microgram injections of pegylated interferon (Pegasys®) 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.

Results
At 12 weeks following the end of treatment, naïve patients who received a triple regimen that included standard of care and nitazoxanide showed a significantly higher SVR (HCV RNA < 10 IU/mL, Abbott m2000) than the group receiving the standard of care regimen (79% vs. 43%, respectively) (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) (+25%; 95% CI: -1%, +47%). 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%.

"Results from this trial validate a new approach to treating HCV that focuses on the interaction between the virus and the cell," said Jean-François Rossignol, M.D., Director of the Romark Institute for Medical Research. "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."

Nitazoxanide is the first of a new class of small molecule drugs called thiazolides that inhibit replication of a broad range of viruses. The drug was discovered by Dr. Rossignol and was initially developed by Romark and approved for marketing in the United States as the first treatment of cryptosporidiosis. Serendipitously, the development of nitazoxanide for treating cryptosporidiosis led to the discovery of its antiviral properties and ultimately to the discovery of a promising new class of antiviral drugs.

Romark is currently conducting a U.S. 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 naïve patients early in 2008.

[orleans]

Hey, My hepatologist didn't hesitate prescribing it for me. He is also doing some of the trials but I wasn't interested as I didn't want to end up in the control. I have the Alinia and will start predosing 7/6. Do keep in touch. jerry ps You did notice that 3 of 3 g1s in this study SVRed?  A small number for sure but still very encouraging!

[eureka254]

Very good news indeed!  I understand that current trials w/Alinia are underway for geno 1, and the data is very encouraging -- enough that though my husband is not eligible for the trial, he might get it prescribed 'off-label' by his hep doc to increase his chances of beating down geno 1.  We hope the results are as good for geno 1 as they appear to be for geno 4!

~eureka