Romark's molecule drug

[lanier]

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."

http://www.pharmaceutical-business-review.com/article_news.asp?guid=8430246C-E498-4D09-89DA-0239EA1966F7

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.

Lanier

[lanier]

I hope you get if in if you want too.  and I wish you well.  
Lanie

[fightit]

Alinia trials are going on now, have been for a few months. The trial nurse where I treated wanted to get me in one but I have to wait 90 days after failing tx. I may wait and see how nonresponders do. I really don't want to treat again if my chances aren't any better than 0-3 %. I am hoping alinia will give me a shot at svr.

[gauf]

Perhaps I am putting a lot of false hope in Alinia, but it seems safe to add to SOC so what the heck. Data on it is slow to obtain for sure, and I believe that this forum will probably give us more info on it sooner than the controlled studies. I am going to add it to my SOC for one.

[copyman]

it must be the facility you work in because of being a clinic setting. if you had a privite practice your palms would be greesed trust me :-)

as for the alinia trials,  should be starting here in USA next year and will start hearing more about it. so far all we have is info from a trial on geno type 4 out of eqypt. the irony of this drug already on the market is that it was found to treat HCV by accident, was givin to co-infected patients for bowel problems and they found that it affected the HCV. there are probably more drugs already approved that could cure this disease, only time will tell.................

[Facta_non_verba]

When you talk about doctor's palms being greased by drug reps, are you talking about the U.S.? If so, I'm getting ripped off!!! I can barely get a mug or ink pen from these guys.

Seriously though, drug reps have very few ways to reward doctors for buying their equipment or prescribing their drugs. What is most valuable to me is if the rep leaves samples, which I can use for patient's without drug coverage. Now that I'm in an County/Academic center we can't keep samples in clinic since all drugs are controlled by the pharmacy. I do get invited out to dinners every once in a while, but to tell you truth I don't feel like spending all evening out with a drug rep when I could be home with my family. I have been able to take courses offered by equipment reps to learn how to use their systems, otherwise I score a couple refrigerator magnets now and then.

Hey, but wasn't this thread about Alinia? I wish there were more published information. The preliminary info is pretty exciting.

[copyman]

your not so cruel after all :-)  your last post was well said, great post to say the least.

[cruelworld]

i am so glad you feel this way. my post in many ways was bashing you, all the while
i was preaching "no bashing"  the art of tact is so difficult at times and i am happy you are not offended.

it is a fine and delicate line that we must all walk to show respect for each other and the tenets that this forum promotes.
i do agree that we need "freedom of speech" around here but there are limits to everything. many transient posters blow through here and try to bash our medicines, our doctors, our pharma companies, our advice,even our need to treat. we will never be able to accept too much of that because those very things are our life line.
imagine a lone and outspoken atheist in a christian congregation. not pretty.  any such forum is not really designed for true and
unlimited free speech. contrary opinions are always welcome but must be expressed with a most humble and thoughtful approach. after all, thats just common courtesy.
when in rome, behave accordingly.
all of us riba ragers are ready to explode at the drop of a hat, tread lightly!

also, i for one have never really cared about "credentials, education or background".
it seems that those who have the wisdom and experience to lead or comfort us,  just shine through the crowd like a bright light. greatness (around here anyway) cannot be missed nor does it need verification. it is just obvious.  on the issue of "medical advice" i have been criticized in the past for "giving medical advice" by someone in the healthcare field. we, here on this forum have a little bit more relaxed format than you/those in the healthcare field. we can get away with more but we still constantly repeat this statement  "in my opinion" and many other statements that serve for us as sufficient disclaimers. i know this is hard to swallow for anyone in your profession but its just the way we do it.
be cool lanier, this is a relaxed fun place where we all really appreciate each others
company. we all have to conform somewhat to fit in, i sure had to. they ran me off several times before i figured it out!

cruelworld signing off

[copyman]

please continue to voice your opinion. that is what this forum is for.  sorry this was not the welcome you had hoped for but  you did come off somewhat angry with your first couple of posts. perhaps if you look at it the way the regulars here did you would understand, a new member saying things about a doctor that we are blessed to have here. we have had pranksters stop here and stir up trouble so we can be defensive at times. dont get me wrong  this is your right in a public forum. all i can say is welcome to this big happy family :-)

[jmjm530]

Well said.

[ladywhy]

I am especially interested in Alinia presently...thanks for the scoop.
Sincerely,
y

[ladywhy]

Bravo!

[lanier]

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.  

Lanier

[cruelworld]

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.

[lanier]

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
Lanier

[jmjm530]

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

[copyman]

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.

[wyntre9]

Congrats to you!

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

wyntre

[copyman]

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.

[St. George]

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.

[lanier]

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

[lanier]

What are you talking about.  Your posts are barely intelligible

this is what you wrote, who r you kidding

[lanier]

do you see the first kline of your post, get up off your knees or put on your bifocals

[wyntre9]

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.

wyn

[lanier]

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.