News article on Alinia

[gauf]

Courtesy of evangelin--------

Researchers say drug suppresses HCV

By Geoff Drushel

  
Body:  
A drug already on the market in the U.S. could be used to greatly increase the success rate of standard interferon treatment in hepatitis B and C patients, should further testing and evaluation lead to government approval. Currently, clinical trials with the drug nitazoxanide, sold under the brand name Alinia, are under way here and researchers are hopeful that it will continue to show the type of remarkable success it has shown in previous trials, including a large one conducted in Egypt between 2005 and 2007. In that trial, patients given the drug along with interferon/ribavirin treatment (standard of care) showed a success rate nearly double over those who received standard interferon/ribavirin treatment alone.

Initially developed to combat diarrhea caused by the emerging parasite Cryptosporidium parvum, the drug, one of a promising new class of antiviral drugs known as thiazolides, was found to have strong antiviral properties that significantly impacted the hepatitis viruses. Trial participants in the Egypt study achieved a sustained virologic response (SVR) of almost 80 percent in those given the drug while on interferon treatment compared to an about 43 percent SVR rate in those who did not take it. Significantly, the patients – all genotype 4 – treated with nitazoxanide also experienced no relapse and no more side effects than patients who received the standard of care. Genotype 4 is to Egypt what genotype 1 is to the U.S.

The drug’s manufacturer, Romark Pharmaceuticals, a biopharmaceutical company headquartered in Tampa, Fla., is continuing to test the drug in phase II clinical trials here in the U.S., and its discoverer believes it ultimately will win approval from the Federal Drug Administration (FDA) for treatment of hepatitis and other similar viruses. Nitazoxanide could be available to patients as early as 2010 to 2011, according to its inventor, Jean-Francois Rossignol, M.D., who co-founded Romark in 1993 and serves as director of the company’s Institute for Medical Research.

“It’s quite a discovery, actually. It’s an interferon-like product, so that’s quite a breakthrough in that (area), and that’s why it’s making quite a lot of noise right now at EASL (European Association for the Study of the Liver) in Milan (see “Treatment Takes Center Stage at EASL Meeting,” p. 10),” says Dr. Rossignol, a 64-year-old, Sorbonne-trained synthetic medicinal chemist and physician who invented thiazolides while attending medical school. “And that’s why AASLD (American Association for the Study of Liver Diseases) took it for the fall meeting.” Thiazolides are a class of small molecule drugs that target cell signaling pathways used in viral replication.

“It is exciting, and we are looking for seeing a great development in not only hepatitis C and B, particularly hepatitis C because of its national priority, but also other viruses down the road,” he says. “And we intend to absolutely pursue registration of the drug very aggressively. But we need to test the drug fully to make sure we have something and have it well recognized by the peer review process, which is why AASLD and EASL are important because these are two – Europe and the U.S. – pretty good, credible peer review processes.”

Romark currently is 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, so called nonresponders. The company also plans to initiate a phase II trial in treatment naive (see “Remaining Naive – or Not,” p. 14) patients this year. “It’s undergoing clinical trials in the U.S., and we should have the communication of the U.S. trials by the fall at AASLD in San Francisco. So we will know the complete story at that point in time – its complete potential,” he says. “What we know right now is that you add the drug to the standard of care, and what you end up with is a pretty high cure rate – SVR in the 80 percent-plus range, which obviously is quite interesting.”

[gauf]

Yes, that's right about something new to report. I assumed it lit up the virons like neon saying here we are. More like Riba, and HR thought so too. As an interferon "booster!?", that is new info for sure.
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passagrille, Don't give up on the Alinia so quick! It is a very hopeful adjunct to SOC, and is available if you "push for it". You can even buy it off label if need be.

[passagrille]

im a gynotype 4, and my doctors dont seem to like alinia, and dont give it much hope guess ill be on the reg treatment.

[merryBe]

I got this drug 6 months into treatment, already UND...and the insurance still approved it, so don't think it can't happen. All my doc did was write in the notes that the drug had shown promise and improved SVR in clinical trials, and it went right through!!

So those interested should not listen to the "oh they'll never approve it" shpeal that both my docs gave me....because they did approve it. (ps. prayer helps).

MB

[eureka254]

Thanks for the updates!  If the success rates prove to be as high for geno 1 as it has been geno 4, it would be most encouraging and very exciting.  

Here in New England, a Phase II trial has already started for both previous non-responders and tx naives.  (The trial we've been looking into for my husband, as I understand it, is a double-blind study of 90 week duration with a 2 to 1 ratio of nitazoxinide to placebo.)  

The quandry is this:  as a geno 1 naive, does he bite the bullet and pocket the cost of Alinia off-label (plus pay 20% of the cost of SOC drugs, and 100% after a $25,000 cap -- a daunting -- and possibly prohibitive -- prospect if extended to 72 weeks or more, especially if rescue drugs are needed), or take our chances at a 67% probability of getting it added to SOC?  

[evangelin]

Quote from article:
"It’s quite a discovery, actually. It’s an interferon-like product, so that’s quite a breakthrough in that (area), and that’s why it’s making quite a lot of noise right now at EASL"
This is just the first article I have seen that says it is" interferon like."  I think that they started out thinking it worked more like the riba. I talked to someone a few weeks back that is part of Romark and they told me this and said that the information was new and came from their European trial and hadn't been published yet.  Some of this information was able to be sent to our insurance company to persuade them to let my husband (a twice non-responder) try the Alinia to see if it causes him to respond.  He wasn't a totally null responder in the past, but not enough to get the job done.   It is too early to tell if my husband will be successful.  The insurance agreed to give him 3 months of Alinia and they will then decide if he is showing a response worthy of continuing on it. Joe had a 1 log drop at the 4 week mark and this, while not spectacular, was better than in previous attempts.  

[gauf]

Yup, good point!

[drofi]

the article is new, the information is old. We are still waiting for publications about SVR-rates in genotyp 1 after Alinia, not some stories about genotyp 4 in Egypt.

[moahunter]

but gauf, we don't know if they work synergistically, and what potential impacts there will be from doing so. It seems to me, that each new drug in the mix has to add something, but ideally not make something worse. I think to the extent that drugs come on stream that can reduce the time of treatment (which Alina might), with minimal side effects, they are a sure bet. But drugs that add extra clealry noticable side effects (like Telepivar), are a more questionable one, at least in terms of mass appeal, versus being perhaps a niche add on for those who don't respond to SOC, or Alina SOC (if that is what we get).

[gauf]

These drugs work synergistically. They all have a role to play and work together to eradicate the virus. Teleprevir and Alinia, and SOC along with the right supplements will be a deadly cocktail for this virus.

[copyman]

It is great to have other options in the pipeline. I still think Telaprevir has the best drug if they can cut tx time in half or less. The sooner you can stop interferon & riba the best chance of not having permanent sx.

[pjhep80]

ok thanks i will check it out

[moahunter]

This is potentially terrible news for Telepivar and other drugs in development though (glad I don't own any stock in them). If Alina is effective and proven to be so, then the Gold Standard of SOC that they have been working to beat, may become redundant overnight, given that Alina is realtivley low cost and seems to have very few side effects. Very good news for us Heppers though, I hope Alina proves effective.

[gauf]

You can get this drug now if you decide to treat. See "alinia" entry in my journal for more info. I am currently on it and responding to treatment.

[pjhep80]

"What we know right now is that you add the drug to the standard of care, and what you end up with is a pretty high cure rate – SVR in the 80 percent-plus range, which obviously is quite interesting.”


!!!!!!!!!

good good good news hope it is all true... im bouncing around whether to keep waiting or try again with SOC, i treated with virimadine and interfuron on a trial 2-3 years ago and it didnt work .... im wondering if i would have more success with the riba and interfuron... i was stage 2/grade 2 last biop so i think i can wait until 2010/11