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Avatar universal

Romark's molecule drug

Alina Seems to be a route some are trying here.  I have spoken with a couple of Pharm Reps local to me, and since this company is based in Tampa,  have gotten some input.  None of it great.  I hope this pans out for those looking for it as an addition to their "other" tratment meds.  no quotes on this part.  I will put the pharm site on the following.

Romark's molecule drug effective against chronic hepatitis C
Romark Laboratories has announced that a randomized Phase II clinical trial showed 79% of interferon-naive patients with chronic hepatitis C genotype 4 receiving nitazoxanide plus the standard of care had a sustained virologic response, or undetectable level of virus, 12 weeks following treatment, compared to 43% of patients receiving the standard of care without nitazoxanide.

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). Patients received 180 microgram injections of pegylated interferon 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.
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 sustained virologic response (SVR) than the group receiving the standard of care regimen (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). 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%. The patients treated with nitazoxanide also experienced no relapse and no more side effects than patients who received the standard of care.
Nitazoxanide is the first of a new class of small molecule drugs called thiazolides that inhibit replication of a broad range of viruses. Romark is currently conducting a US 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.
Jean-Francois Rossignol, director of the Romark Institute for Medical Research, said: "Results from this trial validate a new approach to treating HCV that focuses on the interaction between the virus and the cell. 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."


hope I got that right ( the www)

I I have heard great things here in Florida in the Pharm community about Jean-Francois Rossignol, so I hope this is going to keep the phatm going in the right direction.


34 Responses
144210 tn?1273088782
Yes, this is kind of old news but appreciate the post.
Avatar universal
not sure i understand, you wrote,   "have gotten some input.  None of it great" . did you mean the reps told you that is is not that 'great". from what was said about this drug at the boston study last month was that it was very effective and looking to be very promising. what is good about this drug is it is already approved by the FDA for something else. This means that a doctor could go off label and prescribe it to add to SOC drugs, or buy it in mex or canada and add it to the mix yourself. Trials will be starting in the USA next year.
Avatar universal

Well I remember the company name as being cheap.  the pharm=reps I used to deal with always (just like everybody in healthcare is doing) talks or gossips about who is making what and what is **** at what hospital.  no quotes, just pretty much inside talk about crappy mean, creepy doctors, nurses, pharm reps and always...money comes up.  I understood but cannot give any web page information that these reps never lasted very long.  Anytime I hear the word "cheap" in the same sentence as Pharm-Rep, I know they will have trouble going anywhere fast in their sales calls.  Doctor's are notorious for being cheap, whenit comes to these Reps and the ones with the most perks have an edge, it sounds so wrong, but in a way its a good thing because if a company is willing to shell it out, then they must be sure they have something the doctors will be interested in.  If that did not make sense, you do not need to write back and call me something negative, I already "get" where you stand on my input.

Avatar universal
thanks for your information, there has been alot of interest in alina here.

i have to admit though, i find pharm rep gossip not very useful...i understand the point you are making but for a patient forum it really does not give good information for understanding treatment options or research. for me....any insider information when it comes from marketing reps is dubious until proven otherwise by scientific studies.
surely ones doctor who sifts through the marketing hurrah is more influenced by studies published in journals and such as presented by liver conferences combined with clinical experience.  although docs may be cheap, it might be an understatement to prejudice their treatment interests based on marketing strategies. especially now in healthcare where most all treatment is evidenced based.

personally i have to admit i rely as a consumer of health care, not on the insider gossip but concrete
research studies. the subject of pharm reps influence on clinical practice could be debated but lol
not by me as i would not enjoy it or give much veracity in it.( although i do like all the presents they bring to any practice...lol...as well as support the free sample's that can really benefit those who can not pay for their RX.

hope you are well...my best regards and hugs
Avatar universal
first let me say that we got off on the wrong foot and that is forgotten. i hope you realize i only got upset because i could not sit back and watch someone like HR who helps so many here get bashed. i want us all to get along. god knows we who have this dreaded disease need to stick together and help each other .

as for the pharm reps, my 2 nephews  are reps and i get some of the best info from them. you are right about the perks to docs. i do have to say that they both are good honest college educated and reliable so please dont put all reps into the sleeze catagory. plus all those free samples they provide to family when needed :-)
Avatar universal
never, just like every other profession, some give a damn and have ethics and some don't.  what a kind thing to say, your older than me, and that is so refreshing (smile now) I always like to meet people older than me with this virus.  I don't really care about reading cites, I would sincerely like to know; how do you feel, how is your muscle tone? and energy level? do you have any do's and don't's regarding diet.  I know the animal and saturated fat stuff,but it seems my body does better when I just do not eat at all.  Maybe it's not my physical body, but just the lack of the process of digestion seems to rovide me more enrgy.  I'm trying to figure out how to incorpaorate this to get some muscle tone back.  
thank you again.
L Lanier
135456 tn?1301437624
What are you talking about.  Your posts are barely intelligible.   HR informed the board that Alinia shows great potential.  The drug rep's aren't scientists or doctors and aren't involved in conducting trials.  They are simply pill pushers.
Avatar universal
well professor, the 1st paragragh was a statement about the pharmac-company who manufactures the drug.  CLEAR UNDERSTAND.  the rest was just some COMMENTS on a PERSONAL basis regarding the lack of care this COMPANY seems to take of THE PEOPLE OUT IN THE FIELD speaking to the physicans.  I never said anyone WAS A SCIENTIST, except now maybe I think you are.  a real rocketman you have NO right to critique MY POSTS, go look in the mirror if you need to realize that fact. dultz.  do you have a barrel under your neck.  

and just because I have NOT READ EVERY POST THE HR WROTE DOES NOT mean NOBODY has the right to bring it up.  there are some people who do not spend there days reading backwards.  
173975 tn?1216257775
Thank you.

135456 tn?1301437624
Why so angry?  What an angry women.  And by the way in 4 months I will have the title of Doctor of Chiropractic.  So you may call me doc.  Angry, angry women.  Wow!
Avatar universal
see above and apply liberally.  you people that think you HAVE SOME "BRILLIANT" INSIGHT  are the biggest jokes of them all. just becasue you have no subjective thought process and can not use more thanone side of your brain, get off my back  do you think HR give you gold stars fro attacking people or do you do the same *** kissing at work.
173975 tn?1216257775
I have never claimed to have any insight into hep-C, or much of anything else as a matter of fact.

i'm simply trying to heal, as are most others on forum.

Avatar universal
do you see the first kline of your post, get up off your knees or put on your bifocals
Avatar universal
What are you talking about.  Your posts are barely intelligible

this is what you wrote, who r you kidding

Avatar universal
and if you think the likes of people like you affects my real life, funny, ur a fraudian thesis...id, ego and super ego I think u got stuck in the phalic stage

can you understand that? its as funny as heck to me
135456 tn?1301437624
Wow.  Your rantings remind me of the street people one may run into.  You know the ones with the matted hair, two teeth and full of booze.  Seriously , keep the negativity away from this board and the lame references about Fraud, which by the way most of his work has been discredited by modern psychiatrists. ID, ego , super ego, ha ha ha.
Avatar universal
correction, the doctors are the pill pushers not the reps. the more the docs push the more perks they receive. granted the reps are a piece of the puzzle but ultimately it is the doc who pushes the pills.  as explained to me,  for instance, the docs are going to write for a statin because they do believe it will help with cardiac issues so what the rep does is try and get the doc to write his statin instead of the other companies, no matter what it takes!  it used to be really easy to "take care" of the docs, trips, concerts, shows, etc but now that the gov has clamped down the reps have to be "creative" to greese the palms of docs. mostly take several docs out to a lavish dinner under the disguise of it being for a meeting about the drug, even though the drug is hardly discussed. the last thing the doc wants to do is talk shop when out. and of course the most common thing is the reps bring lunch to the office staffs & docs. every day to a different doc. they actually call and ask the staff/doc what they want for lunch that day. if you can get the staff on your side you can get the 5 mins with the doc and to refill the sample closet.
173975 tn?1216257775
Congrats to you!

I am so impressed that you managed to finish up your studies while on TX.

Avatar universal
to answer your question, i feel ok and hope to get into a trial next year. i want to try and rid myself of this before more damage can be done. i have the normal aches and pains plus fatigue but some of that could be from "old age" :-)  my muscle tone has dropped some but i try and exercise and watch diet as much as i can. i have a great doc that will go off label and add aliana to the combo drugs if i want. that is if i can not get into a trial. i have been promised by 2 prominent docs that they will help me get into a vertex trial, we shall see.
Avatar universal
copy: the most commonCommon cold thing is the reps bring lunch to the office staffs
I try not to schedule an appointment after 11 or before 3PM at my docs, cause around 11:30-12:00 the reps literally cart food in for the entire staff and I'm not talking hot dogs or sandwhiches. I think it take them until around 3PM until they are recovered from all that food. There's a reason not to schedule an operation in the afternoon. Can't tell you how many times I've seen drug reps slip into see the doctor while I've been waiting an hour for my appointment. Many I can slip in with one of your nephews next time:)

Lanier, thanks for the post. Alinia is a frequent topic here and I don't mind a little inside "dish" from time to time.

-- Jim
Avatar universal
I went to Marh harbor and Nassau on the Roche's dime more thanonce.  It was completely legal.  It was not me alone it was a whole unit.  And I had a blast and learned "so much" by the time I got back with my tan, and after diving and spear fishing, oh and I did have my hair braided, but st george, no dreds.  We were all convinced.  that happens for one reason only. money and that comes from doctors, PA's and nurses handing out the right labels.  I mentioned the financial "cheapness" of the company in Tampa, because I think it is a direct link, not just blabber.  they have been and have pattens on piediatric use for this drug so, now this new clinical trial might help them get more flush with cash.  but I see it as no "cure" not by a long shot.

and I read that stbernard was going to pre-treat a 1600mg dose of ribavarin or maybe he is now.....I think that speaks for itself.  what would we all give to see those first blood draw results.  I can't even believe it.

sorry my speeling sucks and my nails are to damn long to type, to lazy to cut them off this week, me and fuman chu
Avatar universal
i personally didnt see anything very offensive on this particular post but obviously
lanier has an agenda that most of us will probably never understand. and it appears
that this agenda may have come from some very hurtful experiences. unfortunately people around here dont consider that a valid excuse for some of the statements made by lanier and others.  i see others amplifying the effect by responding with an equal and opposite form of ugliness. we must avoid this at all costs.

ive never seen the board so friendly, tolerant and accomodating as it has been in the last many many  months, lets keep it that way. to both sides, dont let weird posts ruffle your feathers, have fun with it, be fresh, be creative, use reverse techniques to get your message across. after all, we, the hepper lepers at medhelp are
the most enlightened diplomats on earth. our crushing experiences with inf and riba have humbled and educated us. let us continue to strive for class, style and
sophistication in our messages.  posts that include blows to the head with
baseball bats are not conducive to our healing.  trust me, i used to be the author
of many of such posts and they accomplished nothing except to make me feel bad.
use sophistication to stand your ground, not barbarism.
Avatar universal
I promise I was just trying to make a comment about a pharm company and their budget or lack there of when it came to sales reps.  I did speak of things I herd about the company from other reps in the business who came to a variety of settings I have or had worked in until 2005.

I disagreed with HR, I will never do it again, but in my mind that speaks volumes about things that might never be heard on this forum because some have a stature to high to even debate, let alone question, with out tone ( I have none) could any other healthcare person be allowed to disagree with anothers opinion, if that person had no personal or clinical rapour with the people on this forum?
I asked that question of this webpage and I offered up my education to show I am not a blowhard just trying to be a doltz.

I am sorry, you are right, your post is so true.  

212705 tn?1221620650
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