Aa
Alinia
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.
"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.
Genotype 4 info -
Epidemiological Characteristics and Treatment Outcomes in Individuals with Genotype 4 HCV Infection
By Liz Highleyman
Research has shown that the natural history of hepatitis C virus (HCV) infection and response to interferon-based therapy are influenced by HCV genotype. Genotype 1 is more difficult to treat and is associated with lower sustained virological response (SVR) rates compared with genotypes 2 or 3.
There are less data -- some of it conflicting -- regarding genotype 4, which is being seen with increasing frequency in Europe (though still uncommon in the U.S.).
As reported in the July 2007 Journal of Viral Hepatitis, French researchers analyzed epidemiological features and SVR rates in a retrospective study of 1532 genotype 4 patients, including 1056 infected in France, 227 immigrants infected in Egypt, and 249 infected in sub-Saharan Africa.
SVR rates were assessed in 242 treatment-naive patients who received pegylated interferon plus ribavirin for 48 weeks.
Results
• HCV subtypes 4a or 4d were most common among patients infected in France, where the predominant route of transmission was injection drug use.
• Subtype 4a predominated (93%) among patients infected in Egypt, where transmission was mostly related to parenteral treatment for schistosomiasis.
• More than 7 different genotype 4 subtypes were found among patients infected in sub-Saharan Africa, a group with no apparent single predominant route of infection.
• Liver fibrosis was significantly less severe in genotype 4 patients infected in France or Africa compared with those infected in Egypt.
• However, SVR rates were higher in patients infected in Egypt, compared with those infected in France or Africa (54.9%, 40.3%, and 32.4%, respectively; P < 0.05).
• Overall, better treatment response was observed in patients infected with subtype 4a.
• In a multivariate analysis, the 2 factors independently associated with SVR were infection in Egypt and absence of severe fibrosis.
Conclusion
In conclusion, the authors wrote, "the distribution of HCV-4 subtypes varies with the geographical origin of transmission and affects the SVR following antiviral treatment."
07/10/07
Reference
D Roulot, V Bourcier, V Grando, and others. Epidemiological characteristics and response to peginterferon plus ribavirin treatment of hepatitis C virus genotype 4 infection. Journal of Viral Hepatitis 14(7): 460-467. July 2007.
Epidemiological Characteristics and Treatment Outcomes in Individuals with Genotype 4 HCV Infection
By Liz Highleyman
Research has shown that the natural history of hepatitis C virus (HCV) infection and response to interferon-based therapy are influenced by HCV genotype. Genotype 1 is more difficult to treat and is associated with lower sustained virological response (SVR) rates compared with genotypes 2 or 3.
There are less data -- some of it conflicting -- regarding genotype 4, which is being seen with increasing frequency in Europe (though still uncommon in the U.S.).
As reported in the July 2007 Journal of Viral Hepatitis, French researchers analyzed epidemiological features and SVR rates in a retrospective study of 1532 genotype 4 patients, including 1056 infected in France, 227 immigrants infected in Egypt, and 249 infected in sub-Saharan Africa.
SVR rates were assessed in 242 treatment-naive patients who received pegylated interferon plus ribavirin for 48 weeks.
Results
• HCV subtypes 4a or 4d were most common among patients infected in France, where the predominant route of transmission was injection drug use.
• Subtype 4a predominated (93%) among patients infected in Egypt, where transmission was mostly related to parenteral treatment for schistosomiasis.
• More than 7 different genotype 4 subtypes were found among patients infected in sub-Saharan Africa, a group with no apparent single predominant route of infection.
• Liver fibrosis was significantly less severe in genotype 4 patients infected in France or Africa compared with those infected in Egypt.
• However, SVR rates were higher in patients infected in Egypt, compared with those infected in France or Africa (54.9%, 40.3%, and 32.4%, respectively; P < 0.05).
• Overall, better treatment response was observed in patients infected with subtype 4a.
• In a multivariate analysis, the 2 factors independently associated with SVR were infection in Egypt and absence of severe fibrosis.
Conclusion
In conclusion, the authors wrote, "the distribution of HCV-4 subtypes varies with the geographical origin of transmission and affects the SVR following antiviral treatment."
07/10/07
Reference
D Roulot, V Bourcier, V Grando, and others. Epidemiological characteristics and response to peginterferon plus ribavirin treatment of hepatitis C virus genotype 4 infection. Journal of Viral Hepatitis 14(7): 460-467. July 2007.
Re: wondering if doctors will write rx for Alinia, just ask for it, all they can say is no. I'm lucky to have an open minded, progressive doc who is writing scripts based on my input. I'm on the brink of starting tx and going with the trifecta: Rebif (a peginteron beta-1a), ribavarin and Alinia.
Rebif reportedly has fewer sx than regular peginterferon and is already approved for multiple sclerosis. The downside is that I may not be able to get it "gratis" since it's not FDA approved for HCV. If not, I'll go with SOC peg.
FYI, for those of you who don't have insurance and can state a lower income, free drugs are available from the manufacturers and free lab testing is available from Quest Diagnostics. Also, I think the larger drug stores have programs offering free or heavily discounted drugs to help with sx. With a little homework and some paperwork you may be able to reach SVR without wiping out your life savings/investments.
Best to all,
Kittyface
Rebif reportedly has fewer sx than regular peginterferon and is already approved for multiple sclerosis. The downside is that I may not be able to get it "gratis" since it's not FDA approved for HCV. If not, I'll go with SOC peg.
FYI, for those of you who don't have insurance and can state a lower income, free drugs are available from the manufacturers and free lab testing is available from Quest Diagnostics. Also, I think the larger drug stores have programs offering free or heavily discounted drugs to help with sx. With a little homework and some paperwork you may be able to reach SVR without wiping out your life savings/investments.
Best to all,
Kittyface
Wonder how tough it would be to get ones' Dr to go for the off label treatment?? jerry,Forsee, you don't really seem so "dizzy":)
hate to say who told me this, but some people think that you wouldn't need to take alinia for your entire treatment time anyway, just the first 3 months or so (IF you were thinking about it and had a go from your personal doctor)...this is of course, just an estimation, in unknown waters....something I say with a lot of trepidation.
Kittyface (a member here) had gone on the Alinia herself, and got a 3 month supply. All she did was contact Romark and they were very nice about faxing (?) or sending her the forms, when she told them she didn't have the money for it. They sent her a 3 month supply within a week or so.
I feel kind of uncomfortable posting this on a public forum, but it's not like it hasn't been said before. I was probably too mouthy about HR and what he's doing, lol...you know how it is sometimes when you post late at night, not always the best judgment, particularly from me:)
Kitty said that her sides were negligible, but I think even with the trial people, some people did have stomach troubles, but I forgot all the particulars.
Just want to point out that no one is recommending a relatively untried treatment, but some of this info is promising, just don't know that much yet. Kitty took it as a stand alone treatment, and it didn't clear the virus for her.
It will be very interesting to see it tried out *with* soc with other genotypes, etc... Kitty is going to treat with soc and Alinia herself, I hope I'm not outing her, I think she already posted this, if not, I'm sure I'll be hearing from her if she's psst at my big mouth ha ha! It's good we're using screen names and not our own sometimes.
I feel kind of uncomfortable posting this on a public forum, but it's not like it hasn't been said before. I was probably too mouthy about HR and what he's doing, lol...you know how it is sometimes when you post late at night, not always the best judgment, particularly from me:)
Kitty said that her sides were negligible, but I think even with the trial people, some people did have stomach troubles, but I forgot all the particulars.
Just want to point out that no one is recommending a relatively untried treatment, but some of this info is promising, just don't know that much yet. Kitty took it as a stand alone treatment, and it didn't clear the virus for her.
It will be very interesting to see it tried out *with* soc with other genotypes, etc... Kitty is going to treat with soc and Alinia herself, I hope I'm not outing her, I think she already posted this, if not, I'm sure I'll be hearing from her if she's psst at my big mouth ha ha! It's good we're using screen names and not our own sometimes.
We're countin' on you for the "skinny" (I guess they use that saying way out there in the golden state:)!) Anybody know anything about geno 4? Is it more like 2&3 as far as treatability or more like g1? jerry
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