Possible new an unique HCV drug?

Has anyone got any new information on Romark's anti-diarrhea drug "Alinia" (nitazoxanide), which apparently has been discovered to destroy HCV?  It will not need any safety studies since it has been approved for use with children for quite a while. I believe they went right to stage 2 or 2b studies for HCV in January of this year. I've read nothing since.

[Pdilly]

I just checked the web and found that it is used to treat diariha (spelling on that one) on small children.  They have tested it on AIDs.  The only thing on the web you can't see lots of dates.  Some are old so I could not locate anything new.

[can-do-man]

Some here as of 1-10-06

http://www.alinia.com/index.php/media_center/press_releases/35.html

Hello and welcome, best to ya

[dyce]

47 year ole here , sure be a nice cure . Get rid of the colon plugs and hcv in 1 shot. Welcome aboard.

[Bill1954]

It appears as though Romark is trying to gain player status in this unfortunately lucrative market, eh?

http://www.natap.org/2006/HCV/011006_02.htm

From the press release:
-----------------------------------

TAMPA, Fla., Jan. 10 /PRNewswire/ -- Romark Laboratories announced that it is initiating U.S. clinical development of Alinia (nitazoxanide) tablets for treating chronic hepatitis C.

The company has filed an Investigational New Drug (IND) Application with the United States Food & Drug Administration and plans to seek Fast-Track designation for treating chronic hepatitis C. The initial clinical study in the United States will evaluate Alinia administered orally 500 mg twice daily for 24 weeks as monotherapy compared to a placebo in patients who have previously failed pegylated interferon and ribavirin combination therapy.
-----------------------------------

Interesting stuff, huh? Very vague regarding mechanism of action, though. I was unable to find any trial info through clinicaltrials.gov, so I assume the FDA has yet to grant approval for phase 1 studies.

Wish I

[can-do-man]

How you doing gal. sx's been doing ok?

[fishdoc]

I went to see my doc today, and wimped out. He is just so nice, but it was obvious he has never heard of Berg et al.  He said they want to see a 2 log drop in genotype 1 at the 6 month mark.., which is wrong.... said I didnt have anything to worry about with disease progression because I have normal alts.....said I was probably still a 1/0... no biopsy in last 7 years..lets continue treatment for another three months.. no changes...

I am tempted to go ahead and make the appt with the other Dr. and get a second opinion on the sly....Oh I hate being a wimp... on the plus side-I feel great!!  Leviquan is the stuff man....

[can-do-man]

Oh a little charm and we melt hey fishey. Best to see a new doc if he thinks 6 months for a 1 log drop. And soon. Gald your feeling better though. Oh did we have me fooled. Look at the post i posted to dyce around 15 minutes ago.:)

[amirtracy]

hey there candyman. how are you? hope things are easin' along for you. i'm doing alright. just did shot 13, sx's have settled in, nothing i can't tolerate. getting my 12-week pcr results friday. gonna see about some sleep meds. other than that, i'm doing great. thanks for askin' after me. i think about you often. if i need a lift i look for your posts. so thank you for that. take care and i will talk to you soon!   tracy

[fishdoc]

Hey there, yes of course I have you fooled, remember this is the internet, I'm 33, blond, and skinny as gwyneth paltrow... You know I have no problem jumping out A$$holes, but kicking a puppy, or my doc... rats....

Oh yea, did kick the pup yesterday.... great start to the day-dog had diarrhea on the floor, mom walked in it then wandered all over the house saying "do you smell something...", kicked the dog out and they promply lit into a skunk,...

[fishdoc]

hey there, amitracy, wanted to say thanks for the kind words when I was down....  cannman-lets talk dirty, folks have been tunin in but changing the channel cause other than the alien nurse episode, its been pretty dry stuff...

[can-do-man]

Yeah but isn't it ONLY us MEN who think with the wrong head? Or have you got me fooled there to?

[amirtracy]

oops. hey fishdoc. just wanted to say hello to you. i hope you get some resolve soon w/ this. i'm sending good thoughts your way.
cando's right i think, about another dr.'s opinion, but you know alot more than i do about all this. you'll make the right decision for you. good luck.  tracy

[fishdoc]

You know I can honestly say that up until about 35, I never met a good lookin guy that I didnt scope out the bundle.... but times change, and I just quit lookin.... thats about the time I needed glasses too, reckon that was it?  Boss had a spot on his pants, size of a quarter, 1/2 to his knee.... now there was a time I'd said "woa dude, hanging low.....", but nope not now....now I'm a good girl.... but I did think it..

[DoubleDose]

I have to agree...I would be very concerned if my doctor said that one needed a 2-log drop in 6 months.  This is clearly WRONG, and most studies have shown that not getting a 2-log drop in THREE months just about nullifies any reasonable chance of SVR.  What he might have meant was that you need to be undetected by 6 months, and have a 2 log drop by 12 weeks (3 months).  Even in these cases, where there is a 2-log drop at 12 weeks, and continuing virus by PCR after week 12, but negative by week 26, there is a need for EXTENDED therapy...usually to 72 weeks.  Also, in these cases, the odds of SVR begin to drop dramatically.

You either need to really wake your doctor up, or you need a new doctor!!!!!  Preferably someone who will reliably guide you to the highest probability of SVR, while keeping a solid handle on your liver status, side effects, need for adjunct medications, blood labs while on tx, etc. etc.

If your doctor is not doing viral decline graphs, and analyzing your response pattern, then you are pretty much shooting in the dark.  This is not good, as you are already aware.  Don't be shy about finding a real HCV expert to complete your therapy.  It is your life, your time, pain, suffering, and money.  The outcome is the most important issue of all....and you want to be sure it goes in your favor.

Good Luck!!!

DoubleDose

[fishdoc]

dang dude, I had myself distracted there for a minute!!  But your right, gonna call the other Doc tomorrow, set up a consult... one good reason to keep all your own records, my Dr. need never know......

[can-do-man]

says....bundle..... What was he wraped by the pound? And only to the knee? I guess thats why i don't need a belt. Well i can dream you know.

[fishdoc]

OK, I'm pooped, was it as good for you???

[can-do-man]

Went from all night to riba.:(

[willing]

sheesh...this thread's like one of those motels with the paper thin walls. Maybe they've finally gone to sleep...at least I'm not the one that's gotta to clean up that room in the morning..

Thanks for the Alinia links. Here's the <a href="http://www.fda.gov/cder/foi/label/2005/021498s003lbl.pdf">FDA drug sheet </a>. Looks like a small molecule in search of a job, which is exactly how riba started out. The little snippets here and there paint a pretty grim picture of drug discovery in action:

<em>"A double-blind, placebo-controlled study did not produce clinical cure rates that were significantly different from the placebo control when conducted in hospitalized, severely malnourished pediatric patients with acquired immune deficiency syndrome (AIDS) in Zambia."</em>

but

<em>"The antiviral activity of nitazoxanide was discovered as part of a development program for treating Cryptosporidium infection in patients with human immunodeficiency virus (HIV). "</em>

finally leading to

<em>"An interim analysis of the first 20 patients enrolled in the study showed that 50% of patients receiving Alinia administered orally as one 500 mg tablet twice daily with food had undetectable HCV RNA in serum at the end of 24 weeks of treatment compared to none of the patients in the placebo group (P=0.03)"</em>

[Pdilly]

Gosh I wish someone would know something.  I just went to the trial site and did not see it there.  Oh my....

[kittyface]

BTW, I'm female, 52, infected for 28 years, geno 1, VL 20,000,000

[kittyface]

Read this post first -- I am taking Alinia.  The side effects are non-existent.  The stuff is $23/tablet and dosage is every 12 hours, however, if you prove hardship through paperwork Romark will provide for free.  I've been taking it for 2 months and will do PCR in about a month.

[kittyface]

whoops fast fingers strikes again. . .as I was saying. . .Alinia is expensive but Romark was kind enough to ship 6 month supply after I completed hardship paperwork.

I'll check back in at 12 weeks with PCR results.  BTW, I'm an interferon drop out.  I lasted one week on that stuff.

[FlGuy]

I went out looking for a new doc and felt like I was cheating on the other.  I found a practice where the people (PAs) are knowledgable, up to date, flexibile, do a lot of hcv and are aggressive. They won me over.  In thinking of the former doc I realized that his ego and his feelings were secondary to my health.

[FlGuy]

I work in a building that has headquarters for Latin America businesses. I work with a lot of Spanish and Portugese speaking people who can't help me translate 'consuelo dos gatos'.  What's it mean?

[fishdoc]

uh, Connie Two Cats......nickname from my reservation days...

[FlGuy]

Thanks, now I can actually do some work around here.  Didn't think that it might be a reference to a proper name.
Via con Dios

[can-do-man]

Yeah alot of homes break up that way. After you giving  your all for 6 months too. 'THEY' is not a good way to start a new relationship but i'm not here to judge. I do like the flexibile part though. And really you wasn't cheaten, Sounds like you was given you the screwing  first. But one thing though this some seemed quite eager to go stright to the colon first. Take care guy and i hope these work out for ya.

[FlGuy]

And the real weird thing is that I'm almost eager to begin this stuff again. Re-treating HCV is like re-marriage.  It's the triumph of hope over experience.

[can-do-man]

Could it be its the 'aggressive' part you really like? And i've been married 27 yrs. You might be eager but 27 years of treating I'll let you have the triumph of hope over experience.

Serious though sounds like you got some People who want to go after this. Good luck to ya

[FlGuy]

it will all turn out well, just a matter of time.  The person that won me over was the PA who I have a long conversation with.  She gives good phone.

[can-do-man]

She ought to then. At $3.99 a minute.

[willing]

thanks for the information; best luck on your results.

[fishdoc]

How bout another one?? I have a very good friend that I have worked with since 1978 that recently retired.  I asked his advice on a good spanish issue and what to call it, his response was pinche pescado.....not sure of the spelling....

[FlGuy]

Now I feel that you are setting me up.  I recognized the second word but needed help with the first. I think you just earned a new name. Baically, it's a slightly gentler term for f*****g fish.

[fishdoc]

Yup, you got it!!  I use that one a lot :)

[fishdoc]

I know what you mean... I am very loyal, and I do feel like I'm cheating.....but I agree with all, its my life, my health, and I just have one patient...so as soon as the clinic opens I am going to whine for a quick appointment...if he agrees with the "samo samo" approach for a while, fine, if not..... I just disappear.....from the radar screen..

[57yrsold]

The reason alinia interests me is because I could have a doctor legally prescribe it for me now.  Romark can't advertise it as an hcv cure, but that doesn't mean I can't take it as such.  It supposedly cleared 50% of the people who took it, and it costs a hell of a lot less than inf/rib, which doesn't do any where near that with geno-1b. Some say a more realistic number with inf/rib is 30-40% against geno-1, counting the relapsers. (I don't know about drop-outs...of which there are plenty including me)  I just want a little more info first.  I refuse to poison myself again, and until something else comes up, there's no hope.  (VX 950 in 2008 at the earliest.)   Even at close to $700 for a months supply, it's way cheaper than inf/rib, and I found what appears to be a generic brand of nitazoxanide from an online Canadian pharmacy for $250 for 60 500 mg tabs!   www.discount-canadian-meds.com     This I can afford if my insurance won't pay for it. (And I'm nearly sure that it won't, because it's an off-label use)  Someone in this thread is using it I see, and I'm VERY curious to know how it's going. Someone else said that alinia was going to stage one testing, and I'm pretty sure that's wrong...go to   www.hcvdrugs.com    That says that it went to stage 2 immediatly, and is now undergoing hcv specific testing.  I've known that I've had this bug for 5 years, but I also know now that I was very likely infected 36 years ago.  Geno-1b, 3.5million copies/ml, activity 3of4, stage 2/3 of 4 (fibrosis)  I live in a quite remote area (near the canadian border) and I don't know anyone else with this disease, so it was good finding this site!  Thanks for any input on this.

[kittyface]

Hi, I've been taking Alinia for 2 months now and the side effects are minimal.  The first day I might have experienced slight nausea.  Occasionally I sweat a little, similar to hot flashes.  Last year I was on interferon and NM283 for one week --couldn't tolerate physical and mental effects.  However, in that week my VL went from 17,000,000 to 7,000 so hopefully I'll have the same response to Alinia.

Romark gave me a six month supply for free.  If you can get it from Canada, go for it.  At 12 weeks I'll do a PCR and report the results to everyone.

[57yrsold]

Willing: I'm optimistic that I can talk my GP into it when I make up my mind to go ahead.  Personal circumstances may keep me from moving for a couple of months.  I haven't been evaluated for 2 yrs. because I'm not fond of visits to the doctor, and once went over 20 yrs without an examination...it's time.  I suppose I could tell him I have a REALLY bad case of diarrhea eh!

kittyface:  I'm hoping for the best outcome for you, and will watch for your 12 week results on this site.  I didn't last long with inf/rib either for similar reasons, and I'm a bit disheartened that nearly every new therapy looks like it will be marketed as a combination with inf or inf/rib.  Could this be some kind of backroom deal to keep profits from inf flowing?  I don't think these pharmaceutical companies can be trusted.  I'm glad the stuff works for some people, but I felt sure that it would kill me long before it cured me, and I can't imagine ever taking it again.  I admire your initiative here, and am curious what led you to this approach.

[willing]

57yrsold : sounds like a very reasonable way to go; do you think you'll have any difficulty finding a physician willing to write the rx ?

kittyface:  glad to hear about the minimal sides. How did you make your decision to start on this rx?

I'll be away for about a week but will investigate this a bit more when I get back and post what I find.

[kittyface]

I'm on Alinia b/c I knew I wouldn't emerge intact after a bout with interferon.  I have the deepest respect for those who last the year.  I've been researching alternative methods after discovering my HCV which, BTW, took 25 years to diagnose despite my visits to approx 15 docs over the years complaining about constantly feeling ill for no apparent reason.  But I'm not bitter :)  

So after reading that Alinia had the same cure rate as INF with very few sx my MD simply wrote me a script.  I talked to a receptionist at Romark Pharmaceutical and got the impression that the employees frequently take Alinia for everyday colds and flu.  Knock on wood, don't want to jinx myself or get too optimistic but I think the Alinia is working b/c I FEEL GOOD, no more weakness, nausea, fever, swollen glands.  But we'll know for sure in another month and I'll surely tell all I know.