Looking for info on Alinia

Hi all

Does anyone have any good research info on Alinia that I can share with my Doc?

Thanks much,

mik

[sfbaygirl]

You could go through the archives and get some of HR's old threads about Alinia. I don't have any info. The study in Egypt would be a good source. Also the AASLD conference in Boston this year had a seminar on Alinia.  Good luck!

[gauf]

Look in the "Alinia" post in my journal. In my profile. Cut and paste. Good luck.

[sfbaygirl]

We are going to have to use your profile as the info page!  Thanks!

[Proactive]

While Alinia is tossed around here like the second coming, the fact is, there is very little info available about the drug with relation to Hep C..only a small Egyption study done on Geno 4's...other than that, there ain't much. They have begun a second trial.
http://www.romark.com/news/11022007.aspx
Pro

[Proactive]

Noticed you updated your profile yesterday...Down 55 lbs., Congrats and keep up the great work!!
pro

[sfbaygirl]

Apparently, many Dr's at the conference saw it as the second coming, as well!  We now have Dr's prescribing Alinia during a 48 week course of tx. Yes, we may be excited by this, I know I am, but rightfully so given the stats.  

Linda

[Proactive]

"but rightfully so given the stats" The fact is there are no "stats" for geno 1's...Are you a geno 4?
PS: you make it sound as if assld was help expressly for the purpose of discussing alinia, I don't believe that was the case at all. Results of the alinia trial had just come out, thus one can understand some excitement over the drug...But extrapolating it out to geno 1's as gospel, I'm not sure how helpful that is..remember it's just begun phase 2 trial for hep application.

[sfbaygirl]

You are correct, it was for geno 4's. But those of us relapsers and non responders may need to do something more aggressive now. Maybe I am overly excited by what I have heard about the conference and the response from the seminar.  You know the stats we are dealing with as relapsers. SOC is not going to cut it for us g 1's that have relapsed. It isn't gospel, but at this point I see no harm and possibly a lot of good for us to try it.  

[gauf]

Thanks for that comment! It is true that the jury is still out on Alinia, but with a low sx profile, reasonable cost, and only as an adjunct to SOC, what have we got to lose? I feel good about it "in my gut".  Anyway, you must be close to ending your tox huh? I pray you slay the dragon dude! God Bless.

[Proactive]

I can understand your excitement, especially as a relapser (I may be in the same boat in a few months, who knows)...But we still have to weigh the excitement with a dose reality.
PS: I appoligize if you took offense to my post, wasn't intended that way...I should learn not to post---post shot (g)

[Deb_c430]

I still have a lot of questions about alinia,    and the country of origin of the original study.

Egypt is filthy, and 2,3,4s are so different from us. 1as. My understanding is the strain of hepc is very different, in the middle east.

I am also concerned about the remaining side effects,  till a few more studies are done, call me prudent, cautious, chicken,  but I think I will wait.

I am  hoping of course that for us relapsers and non responders there is  some great  news coming out of these studies. I am not jumping on the bandwagon myself yet.

But I am quitely hoping to see great results and another option to cure this croc!

Deb

[sfbaygirl]

No offense taken!  It is good to call it as you see it.  I am overly excited and know others are too. I sure hope you have SVR!  

[Proactive]

Thanks buddy, yep 20 days left and counting....and I'm getting more nervous by the day...Next appointment is scheduled for a week after tx completion...Trying to stay grounded, I'm well aware of what my odds are....and let's just say, if it were a stock, I wouldn't buy it (vbg)
;^)pro

[Forseegood]

as almost always, I think the truth lies in the middle colors...we don't really know much about this drug, of course...just that - that many patients to be undetectable at the end of treatment, vs. the people that didn't take it, is a good think to look at for sure...have it on good authority that many docs were excited to see the doctor heading the trial from Egypt...

and they said he must of been intimidated,(my own doc was there too)....to see that many big powerful liverheads from all over the world to see him present, the big hall there was packed to the rafters...

But they said he seemed very humble and presented his trial data well...personally, I'm going to take it for a little while before I treat, just to see how I react to it, Kittyface here took it for 3 months and she said she barely had any sx;s....

if it does a real number on me for some reason, I'll reconsider taking it as an adjunct with SOC...if it's mostly okay...I will take it with soc...HR is on board with my plans as a good idea, so is my own liverhead at Cedars....but yeah, who knows?, could be mostly a wash....more shall be revealed...

[Deb_c430]

For sure I hope it is a good thing.   I am just a cautious person, and want to see a bit more.  

Good to hear he is a recognized liver head,  my one and only trip to Egypt was not what i expected.   Dirty, is the kindest word I can come up with.  We took a boat trip down the nile and they were passing out imoden like candy.

If I do not  SVR this time around and relapse again, i maybe ready to consider it.   Just right now I am not ready for it. Infact I may just not tx again at all. Enjoy life!

I am 1 a tho also.

I do wish you well,  and fingers crossed it will work for you!  When do you start tx? Are you waiting on a study?    

[Forseegood]

no, I had other issues and I guess they had to put me through the ringer in getting releases from other docs, etc...but now it's supposed to be a go...just waiting...thanks for the vote of confidence...I prob wouldn't want to throw anything in the mix later on in tx, that's for sure...we'll see..sometimes you can't always tell about the medics in countries because they are third world...India has many good docs, and I had excellent dental work done in Mexico a while back....oh, this whole thing is driving me crazy, better go watch some tv or something, ha ha ha! be well.....

[Deb_c430]

I so understand that! I have Docs from all over the world, actually my GI is Indian and he is wonderful

Some were great, some were not!  Not really fair to generalize/

I feel like we are playing ping pong!

I know exactly how you feel,  it is so confusing and so hard sometimes to find the right answers. to not be fearful,  I mean how can you not be?

Me to, dinner time and time to give my eyes a break!  and you.

[ClippedWings]

I used Alinia in conjunction with Pegasys and Ribavirin without success.  I just put that out because like many, I jumped on the opportunity to try something else when it was apparent that SOC wasn't working for me.  I was 16 weeks into treatment with less than a one log drop when I started Alinia.  After 24 weeks, my viral load had actually increased slightly.  I hope I'm the exception to the rule and this drug does turn out to be a miracle cure.  Those who are contemplating taking Alinia please don't be discouraged by my story- I did not take the drug in the manner prescribed in the trials, it is entirely possible that there is a need to preload with Alinia prior to starting SOC.  Additionally, I doubt any drug will ever be a 100% answer, so hopefully I'm part of a small minority that doesn't respond to Alinia.  
  I have stopped treatment for now but will probably go in for round two in the fall.  Which brings me to a question- What do you do with your leftover meds if you discontinue treatment?  I have 174 Copegus tablets, two Pegasys injectors, and a couple of dozen Alinia.  Is there an organization that takes leftover meds to give to those who can't afford them?

[sfbaygirl]

Sorry to hear you didn't make it. Sounds like you were a non responder. If I may ask, why would you do this again, if you aren't responding to Interferon?  

Yes, we are in uncharted waters with the Alinia. I am sure someone would love to get those from you. If you do so, do it by private message. How did you get your Alinia?  So many are trying to get it and can't. Mexico is expensive and some have had customs problems. It would be nice to hear your story. What are your stats? Geno, stage, 1st timer, etc.  

I hear some hospitals take drugs you donate. Some don't. depends where you are.  

Hey welcome and keep posting!  

Linda

[Mikkimoe]

Gee look what I started....good discussion - thanks

Does anyone happen to have that article on the trial in Egypt? I'd like to give it a look.

I have been in many trials with my RA and am pretty much a risk taker - if I thought my chances were improved to SVR and I could tolerate it with the other meds (Big "if" with me...allergic to many things) Then I would probably try it.

[ClippedWings]

I'm contemplating my next try at treatment because when I found out I had HCV back in July I also found out I had cirrhosis and esophageal varices.  I'm a genotype 1a. In my mind my only choices are to treat or wait for my liver to quit on me which my doctors say is very likely in the next 5-10 years and I'm only 45 so that is a result that is not satisfactory to me.  An additional reason is that treatment was not very hard on me.  I experienced a little fatigue, but not nearly the problems I've heard of from many here. For that reason I think I'm willing to try the daily consensus interferon and ribavirin.  

I had no problem getting Alinia.  I found out about the drug from this website and by reading reports coming out of the liver conference in Boston back in November.  By that time I already knew I was likely a nonresponder so I was researching other options.  The first time I mentioned it to my doc he told me he had never heard of it, so I gave him results of the Egyptian study and asked him to look into it.  I went back to see him the next month and he had done his homework.  He essentially told me in his mind the drug would do no harm and he left it up to me.  I asked him to write a prescription for it which he did.  I took it to my local Walmart gave them my insurance card and paid my $10 copayment for a months supply.  So far my insurance company has not asked me about it.   My intention all along was to wait and see if the insurance company challenged the bill which they have not so far.  I figured by the time the paperwork caught up to me I would have a couple of months of Alinia treatment under my belt and could either say "Look it's working!" or "Oops, my bad, I'll stop now how much do I owe you?"
Good luck to all!

[sfbaygirl]

Good job!  

[Deb_c430]

Clipped it was interesting to read this.  You confirm some of my fears, I am so sorry that, that is so though.    

I truly think that this virus is different for everyone,  genotypes being different, mutations being different.  Personal body reactions.    
very much like the flu as we know it, every year the strain changes and so do the vacinations.

I am also 1a,  some may find it works for other strains, but not 1a,  2, or 3.

Your lucky your insurance coveried it, mine does as well but only for three days. Not a long term script.  It is not FDA approved for hep,  nor is infergen which I am on now, nor procrit, but they both have a track record, so insurance cos let them slide.

Thanks so much for the input, Best of luck in your next decision and hoping it all works out for you!

Deb

[Forseegood]

HR and my doc told me in order for this stuff to help, *if* it's going to...it really should be taken a little before, and/or at the start of tx...

HR said that he really doesn't think that the genotype is going to matter that much, in the mechanics of how Alinia works, as opposed to soc...but of course, we'll see....like I said, could be a wash, but it's not like it's very harmful...so, to me, it's worth a try....

[Forseegood]

forgot to say again for those who are interested...Kittyface said it's no problem in getting Alina from the manufacturer...once you get a script from your doctor...

[sfbaygirl]

Sorry to hear you are a non responder. I don't plan on tx'ing anytime soon, but do plan on using the anti virals that HR has mentioned. He said he had a guy go from a 15 fibroscan to an 8 in a year! That is two stages!  I sure would try it. Gauf's profile has it, plus a number of threads lately.  

Linda

[Deb_c430]

I have to go, but remind me mikkie or 4c  to tell about the conversation my nurse, (the good one who specializes in livers) told me! you will both die laughing!  

Talk about timing!

[Bigfloyd]

What is the thinking behind starting Alinia before or simultaneously with SOC? I am at week 54/67 1A und at week 19 and thinking of finishing the last 3 months with Alinia in the mix in hopes that will undo any stragglers.
-BF

[ClippedWings]

Linda,
  I'm looking at any and all options.  A liver friendly diet, helpful supplements, and getting the right amount and type of exercise are about the only things I can really do to help control the course of the disease.  Although my biopsy clearly showed cirrhosis, I did have an advantage in that a surgeon did my biopsy via lathroscopic surgery.  The advantage to that was I actually have seen pictures of my entire liver.  I have very few nodules and they are widely spread across my liver as opposed to some of the frightful pictures I've seen on the net.  As the surgeon said "you've got lots of healthy liver left".  I hope to keep things that way!

Forseegood,
  You are right.  The studies that are ongoing for Alinia involve preloading with Alinia prior to starting the Pegasys and Ribavirin.  That may turn out to be a key element in the success of the drug.  Some other contributors to my failure to reduce viral load with Alinia are my advanced case of HCV and the fact that I was taking an antibiotic for a sinus infection the first couple of weeks of Alinia/Interferon/Ribavirin treatment.  Could have easily impacted the treatment in ways not yet known.  The side effects of Alinia were very mild.  The most prominent side effect was a truly bizzare urine color- almost a florescent yellow-green.  Kinda like a glowing Mountaind Dew!  That cleared up in a day.
Best of luck to you.

[sfbaygirl]

Wow that BX you have sounds fascinating! You can see the whole liver, wow! That is what I like about the fibroscan. I haven't heard anyone else having that done. Please check out Gauf's profile, he has HR's liver lovers diet. HR tests this stuff on himself, but admitted he wasn't sure which one of these supplements was the best one. I think the Curmadin was the most exciting to him, but to be sure, take them all. It was pretty amazing to hear of someone going down from stage 4 to stage 2 in a year, not on tx.

Linda

[Forseegood]

Oh My God...did you take a picture! geez...I might freak out if I saw that Pee....yikes! good on you!!!!!!

[sfbaygirl]

What picture? Am I seeing things?

[Mikkimoe]

Thanks for all the great info and graphics...dew pee - wow

Anyway I guess I'm still wondering...does anyone happen to have that Egypt article so I can share it with my doc....don't think his response would be to different then any of the others docs if I tell him that I heard it on an online forum..lol

Thanks

[ClippedWings]

Mikki,
  Here you go:

Phase II Study Shows that Nitazoxanide Significantly Improves Response to Standard of Care in Patients with Chronic Hepatitis C
http://www.earthtimes.org

TAMPA, Fla., Nov. 2 /PRNewswire/ -- Romark Laboratories, a privately-owned biotechnology company, today announced results of a randomized phase II clinical trial showing that 79% of interferon-naive 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(R)) 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, naive 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-Francois 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 naive patients early in 2008.

About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), a virus spread through direct contact with the blood of infected people. Chronic HCV infection may cause liver cirrhosis or hepatocellular carcinoma. An estimated 3.2 million people in the U.S. are chronically infected by hepatitis C virus. Globally, an estimated 170 million people are chronically infected, with three to four million persons newly infected each year, according to the World Health Organization.

About Romark Laboratories
Romark Laboratories, L.C. (http://www.romark.com/) is a privately-owned biotechnology company committed to the discovery and development of innovative new small molecules for treating infectious diseases, cancers, and autoimmune diseases.

About Alinia
Alinia (nitazoxanide) is indicated in the United States for treatment of diarrhea caused by Cryptosporidium parvum or Giardia lamblia in patients 1 year of age and older. Alinia has not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients. The most common adverse events reported by patients receiving Alinia have been abdominal pain, diarrhea, headache and nausea. In controlled trials, the frequency of these events has been similar to patients receiving a placebo. Alinia is an investigational new drug in the United States for treating chronic hepatitis C.

[Mikkimoe]

Thanks much...

It's nice that I can email this trial to my doc...Don't know to many docs that will do that. (Then again I found his email on an online link somewhere)...but he responds within a day usually.

[Proactive]

"HR said that he really doesn't think that the genotype is going to matter that much, in the mechanics of how Alinia works" This could very well be true due to it's possible cellular targeting as opposed to viral, but think it is pretty early in the game for conclusions...
Here's a link for you
http://www.informedhorizons.com/hepdart2007/pdf/hepdart07_presentations/Tues_04_Korba.pdf

[Mikkimoe]

Thanks much - I'll attach this link with my report to my Dr. I may consider a shorter tx time if this is added to the mix.

Looks like you have a last pill day approaching - long journey eh?

Good Luck!

[Forseegood]

hey, thanks for that! love the fact there are real research hounds on this site...do people a lot of good....

Big Floyd and Clipped Wings: well, the way I figure it, which doesn't account for a whole lot cause I sure don't know that much...they barely are getting a read on how soc works, being that there are sooooo many variables here, so they know almost nothing about alinia...I'm just thinking, this is a drug that's been on market for a long time now, with hardly a negative profile, so it's worth me taking a shot...they just know *something* about the preloading and simultaneous use of it with soc...but who knows? maybe it would help *someone* out, even mid treatment, I just don't think they know all that much at all...just figure, IF it can help my odds, (which we all know aren't the best with this treatment) why not give it a shot? can't hurt that much?

[ClippedWings]

Absolutely!  That was my mind set also- I was getting nowhere with SOC and Alinia had a good record of not having significant side effects so I gave it a try and am glad I did.  The only sides I experienced were constant loose stool the entire time I was on it and the neon urine.  Both of those sides cleared up within two days of discontinuing Alinia.  Good luck.

[Hepatitis Researcher]

In the korba presentation at hepdart that you provided, did you notice that the in vitro Alinia testing used geno 1a and 1b Replicons to test the efficacy and that it was found to be very effective against both these genotypes? Some would consider this as early evidence to support the hope that in vivo efficay against these genotyopes will indeed become evident. No further conclusions are drawn.

[Proactive]

Hi HR, yes I did notice that (not that I fully understand the slide set presentation), it certainly looks like there is a high degree of potential there and hopefully the ongoing phase 2 trial data will give some solid evidence of confirmation..I hope you will be able to post anything new that comes up at the meeting you are attending in New Zealand (?)..
thxs.