Medical Forum / Diseases and Disorders / Hepatitis / January 2006
Alinia
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mc - 13 Jan 2006 01:52 GMT This drug is on the market now for use in intestinal infections and now I read that they have some studies that show effectiveness in HCV. A new study is in the works. anyone know anything about it? mc
greyhackles - 13 Jan 2006 02:40 GMT >This drug is on the market now for use in intestinal infections and now I >read that they have some studies that show effectiveness in HCV. A new study >is in the works. anyone know anything about it? >mc http://www.natap.org/2006/HCV/011006_02.htm
Could be very interesting, particularly because Alinia is already marketed in most if not all parts of the world, so the regulatory path could be very short.
Cheers
/greyhackles (very pleased to see all this pharma attention to HCV!)
Doug - 13 Jan 2006 02:44 GMT >>This drug is on the market now for use in intestinal infections and now I >>read that they have some studies that show effectiveness in HCV. A new [quoted text clipped - 12 lines] > > /greyhackles (very pleased to see all this pharma attention to HCV!) Romark Seeks FDA OK Romark Laboratories of Tampa said Tuesday it filed an application with the Food and Drug Administration seeking permission to market its drug Alinia for treatment of hepatitis C, a chronic liver disease. Alinia is already approved for use against two common diarrheal diseases. The company wants to compare Alinia's performance in U.S. trials, following promising results in Egypt.
Here's something I found Doug
Doug - 13 Jan 2006 02:48 GMT >>>This drug is on the market now for use in intestinal infections and now I >>>read that they have some studies that show effectiveness in HCV. A new [quoted text clipped - 20 lines] > to compare Alinia's performance in U.S. trials, following promising > results in Egypt. Here's something I found Doug
I heard they 're using it solo as a monotherapy, or at least trying to. How long will it take to get FDA ok? Grey, Thomas, anybody know...?
Doug
greyhackles - 13 Jan 2006 03:25 GMT >>>>This drug is on the market now for use in intestinal infections and now I >>>>read that they have some studies that show effectiveness in HCV. A new [quoted text clipped - 27 lines] > >Doug That's an interesting question in this case. If a doctor is convinced an already-approved-drug would be helpful where no alternatives have worked, I believe s(he) can prescribe same for "off-label" use, even without the regulatory agency having approved the same drug to be marketed for that specific purpose.
Ie, if you could find and convince a doc that this was your only shot and it would do more good than harm, you might be able to legally use it now.
I haven't spend much time googling this Alinia so I don't know what it's safety profile looks like, but assuming there weren't any grave issues using it to this point, perhaps this could be a player within a year or so.
Cheers
/greyhackles
Michael Cody - 13 Jan 2006 03:33 GMT >>>>>This drug is on the market now for use in intestinal infections and now I >>>>>read that they have some studies that show effectiveness in HCV. A new [quoted text clipped - 44 lines] > > /greyhackles Makes you think that when you thought a new tx for Hep C wasn't coming round any time soon, it may come round anyway. I like it and it's about time Hep C is beginning to get some real attention. I reckon some rich folks got it ...
Cody
Use the Reply to Sender feature of your news reader program to email me. Utiliza Responder al Remitente para mandarme un mail.
Whatsup Doc - 14 Jan 2006 05:07 GMT hcv hits rich people also, Cody.
elmoemerson@webtv.net - 14 Jan 2006 13:40 GMT Re: Alinia Group: alt.support.hepatitis-c Date: Sat, Jan 14, 2006, 12:07am (CST+1) From: coinsinwell1111@webtv.net (Whatsup Doc) hcv hits rich people also, Cody. //////////// That's sooo profound of you, Randy. To what do you attribute your knowledge and intelligence? elmo
http://community.webtv.net/elmoemerson/DocElmosHepFile
http://community.webtv.net/elmoemerson/TheFamilyAlbum
Waterspider - 14 Jan 2006 18:43 GMT Re: Alinia
Group: alt.support.hepatitis-c Date: Sat, Jan 14, 2006, 12:07am (CST+1) From: coinsinwell1111@webtv.net (Whatsup Doc) hcv hits rich people also, Cody. //////////// That's sooo profound of you, Randy. To what do you attribute your knowledge and intelligence?
Aw, take it easy on the kid... he is only 12. Isn't he?
elmoemerson@webtv.net - 14 Jan 2006 19:29 GMT Re: Alinia Group: alt.support.hepatitis-c Date: Sat, Jan 14, 2006, 10:43am (CST-2) From: waterspider@moonlight.net (Waterspider) <elmoemerson@webtv.net> wrote in message news:20330-43C8FF5F-708@storefull-3251.bay.webtv.net... Re: Alinia Group: alt.support.hepatitis-c Date: Sat, Jan 14, 2006, 12:07am (CST+1) From: coinsinwell1111@webtv.net (Whatsup Doc) hcv hits rich people also, Cody. //////////// That's sooo profound of you, Randy. To what do you attribute your knowledge and intelligence? Aw, take it easy on the kid... he is only 12. Isn't he? ///////////// Uhhh, I guess. elmo Watching Soul Train with the sound turned off and Albert Collins and Johnny Copeland amped to the max. Damn, them gals sure can shake that THING!! ahahahahahaha!!!!!!
http://community.webtv.net/elmoemerson/DocElmosHepFile
http://community.webtv.net/elmoemerson/TheFamilyAlbum
Waterspider - 14 Jan 2006 20:08 GMT > Re: Alinia > [quoted text clipped - 18 lines] > THING!! > ahahahahahaha!!!!!! Did you see Greyhackles' post about Pandora? Presuming you've got that pc hooked up and highspeed internet, here's the link from Greyhackles: http://www.pandora.com/ You'll love it! Right now, I'm listening to One Room Shack, Buddy Guy! Only problem is you have to be in the USA <g>
Spidey
elmoemerson@webtv.net - 15 Jan 2006 15:17 GMT Re: Alinia Group: alt.support.hepatitis-c Date: Sat, Jan 14, 2006, 12:08pm (CST-2) From: waterspider@moonlight.net (Waterspider) <elmoemerson@webtv.net> wrote in message news:12634-43C95115-126@storefull-3254.bay.webtv.net... Re: Alinia Group: alt.support.hepatitis-c Date: Sat, Jan 14, 2006, 10:43am (CST-2) From: waterspider@moonlight.net (Waterspider) <elmoemerson@webtv.net> wrote in message news:20330-43C8FF5F-708@storefull-3251.bay.webtv.net... Re: Alinia Group: alt.support.hepatitis-c Date: Sat, Jan 14, 2006, 12:07am (CST+1) From: coinsinwell1111@webtv.net (Whatsup Doc) hcv hits rich people also, Cody. //////////// That's sooo profound of you, Randy. To what do you attribute your knowledge and intelligence? Aw, take it easy on the kid... he is only 12. Isn't he? ///////////// Uhhh, I guess. elmo Watching Soul Train with the sound turned off and Albert Collins and Johnny Copeland amped to the max. Damn, them gals sure can shake that THING!! ahahahahahaha!!!!!! Did you see Greyhackles' post about Pandora? Presuming you've got that pc hooked up and highspeed internet, here's the link from Greyhackles: http://www.pandora.com/ You'll love it! Right now, I'm listening to One Room Shack, Buddy Guy! Only problem is you have to be in the USA <g> Spidey //////////// This webtv have WinAmp or Pandora? ahahahahahaha! I'm able to listen to almost 20 seconds of audio if I get it in an mpeg file. Hey Spidey. Check out the CD "Showdown" with Albert Collins, Johnny Copeland and Robert Cray. Did you check out the Tripwire Band website I sent ya? Not Tripwire from Maryland, the one that's from the Ozarks. I heard em play at a club called Archie's last night and they were their usual fabulous. They played 'Little Wing' by Hendrix, Nathan's guitar solo was unbelievable. He picked the guitar with his teeth and did the behind the back thing. Really entertaining! Elmo
http://community.webtv.net/elmoemerson/DocElmosHepFile
http://community.webtv.net/elmoemerson/TheFamilyAlbum
Doug - 13 Jan 2006 03:34 GMT >>>>>This drug is on the market now for use in intestinal infections and now >>>>>I [quoted text clipped - 40 lines] > regulatory agency having approved the same drug to be marketed for that > specific purpose. That's right... I use neurontin for foot pain, even though it's not legally marketed for that.
> Ie, if you could find and convince a doc that this was your only shot and > it [quoted text clipped - 4 lines] > using > it to this point, perhaps this could be a player within a year or so. It looks pretty safe mostly abdominal pain, nausea, diarreaha, etc.
> Cheers > > /greyhackles Thanks, Doug
kjoh - 13 Jan 2006 04:30 GMT Hi Folks, the info below is from the 2005 Physician's Desk Reference (CD):
ALINIA (nitazoxanide) www.romark.com
Metabolism: Following oral administration in humans, nitazoxanide is rapidly hydrolyzed to an active metabolite, tizoxanide (desacetyl-nitazoxanide). Tizoxanide then undergoes conjugation, primarily by glucuronidation. In vitro metabolism studies have demonstrated that tizoxanide has no significant inhibitory effect on cytochrome P450 enzymes.
Elimination: Tizoxanide is excreted in the urine, bile and feces, and tizoxanide glucuronide is excreted in urine and bile. Approximately two-thirds of the oral dose of nitazoxanide is excreted in the feces and one-third in the urine.
Special Populations Patients with Impaired Hepatic and/or Renal Function: The pharmacokinetics of nitazoxanide in patients with impaired hepatic and/or renal function has not been studied.
Geriatric Patients: The pharmacokinetics of nitazoxanide in geriatric patients has not been studied.
MICROBIOLOGY Mechanism of action The antiprotozoal activity of nitazoxanide is believed to be due to interference with the pyruvate:ferredoxin oxido-reductase (PFOR) enzyme-dependent electron transfer reaction which is essential to anaerobic energy metabolism. Studies have shown that the PFOR enzyme from Giardia lamblia directly reduces nitazoxanide by transfer of electrons in the absence of ferredoxin. The DNA-derived PFOR protein sequence of Cryptosporidium parvum appears to be similar to that of Giardia lamblia . Interference with the PFOR enzyme-dependent electron transfer reaction may not be the only pathway by which nitazoxanide exhibits antiprotozoal activity.
PRECAUTIONS General: The pharmacokinetics of nitazoxanide in patients with compromised renal or hepatic function have not been studied. Therefore, nitazoxanide must be administered with caution to patients with hepatic and biliary disease, to patients with renal disease and to patients with combined renal and hepatic disease.
ADVERSE REACTIONS Alinia Tablets: In controlled and uncontrolled clinical studies of 1,628 HIV-uninfected patients age 12 years and older who received various dosage regimens of Alinia Tablets, the most common adverse events reported regardless of causality assessment were: abdominal pain (6.7%), diarrhea (4.3%), headache (3.1%) and nausea (3.1%). In placebo-controlled clinical trials using the recommended dose, the rates of occurrence of these events did not differ significantly from those of the placebo. In placebo-controlled trials of HIV-uninfected patients age 12 years and older who received Alinia Tablets for the treatment of diarrhea caused by Giardia lamblia , approximately 1% of patients discontinued therapy because of an adverse event.
Adverse events occurring in less than 1% of the patients age 12 years and older participating in clinical trials of Alinia Tablets are listed below:
Body as a Whole: asthenia, fever, pain, allergic reaction, pelvic pain, chills, chills and fever, flu syndrome.
Nervous System: dizziness, somnolence, insomnia, tremor, hypesthesia.
Digestive System: vomiting, dyspepsia, anorexia, flatulence, constipation, dry mouth, thirst.
Urogenital System: discolored urine, dysuria, amenorrhea, metrorrhagia, kidney pain, edema labia.
Metabolic & Nutrition: increased SGPT.
Hemic & Lymphatic Systems: anemia, leukocytosis.
Skin: rash, pruritus.
Special Senses: eye discoloration, ear ache.
Respiratory System: epistaxis, lung disease, pharyngitis.
Cardiovascular System: tachycardia, syncope, hypertension.
Muscular System: myalgia, leg cramps, spontaneous bone fracture.
Waterspider - 13 Jan 2006 08:29 GMT (sorry; top-post)
Thanks, Kojoh and Koko.
Hey, Elmo, d'yah see where the stuff was tested on peeps with Beaver Fever? Ahahahahahaha!
> Hi Folks, the info below is from the 2005 Physician's Desk Reference (CD): > [quoted text clipped - 81 lines] > > Muscular System: myalgia, leg cramps, spontaneous bone fracture. elmoemerson@webtv.net - 13 Jan 2006 13:52 GMT Beaver peeps? Sorta like the pussy's version of Tom Thumb, eh? elmo "Hello in there! Anybody home?" <echo echo> ////////////// (sorry; top-post) Thanks, Kojoh and Koko. Hey, Elmo, d'yah see where the stuff was tested on peeps with Beaver Fever? Ahahahahahaha! "kjoh" <kjohyayhoo@nospamyahoo.com> wrote in message news:4fe10341f903b33c4ad02baec0173488@localhost.talkaboutsupport.com... Hi Folks, the info below is from the 2005 Physician's Desk Reference (CD): ALINIA (nitazoxanide) www.romark.com Metabolism: Following oral administration in humans, nitazoxanide is rapidly hydrolyzed to an active metabolite, tizoxanide (desacetyl-nitazoxanide). Tizoxanide then undergoes conjugation, primarily by glucuronidation. In vitro metabolism studies have demonstrated that tizoxanide has no significant inhibitory effect on cytochrome P450 enzymes. Elimination: Tizoxanide is excreted in the urine, bile and feces, and tizoxanide glucuronide is excreted in urine and bile. Approximately two-thirds of the oral dose of nitazoxanide is excreted in the feces and one-third in the urine. Special Populations Patients with Impaired Hepatic and/or Renal Function: The pharmacokinetics of nitazoxanide in patients with impaired hepatic and/or renal function has not been studied. Geriatric Patients: The pharmacokinetics of nitazoxanide in geriatric patients has not been studied. MICROBIOLOGY Mechanism of action The antiprotozoal activity of nitazoxanide is believed to be due to interference with the pyruvate:ferredoxin oxido-reductase (PFOR) enzyme-dependent electron transfer reaction which is essential to anaerobic energy metabolism. Studies have shown that the PFOR enzyme from Giardia lamblia directly reduces nitazoxanide by transfer of electrons in the absence of ferredoxin. The DNA-derived PFOR protein sequence of Cryptosporidium parvum appears to be similar to that of Giardia lamblia . Interference with the PFOR enzyme-dependent electron transfer reaction may not be the only pathway by which nitazoxanide exhibits antiprotozoal activity. PRECAUTIONS General: The pharmacokinetics of nitazoxanide in patients with compromised renal or hepatic function have not been studied. Therefore, nitazoxanide must be administered with caution to patients with hepatic and biliary disease, to patients with renal disease and to patients with combined renal and hepatic disease. ADVERSE REACTIONS Alinia Tablets: In controlled and uncontrolled clinical studies of 1,628 HIV-uninfected patients age 12 years and older who received various dosage regimens of Alinia Tablets, the most common adverse events reported regardless of causality assessment were: abdominal pain (6.7%), diarrhea (4.3%), headache (3.1%) and nausea (3.1%). In placebo-controlled clinical trials using the recommended dose, the rates of occurrence of these events did not differ significantly from those of the placebo. In placebo-controlled trials of HIV-uninfected patients age 12 years and older who received Alinia Tablets for the treatment of diarrhea caused by Giardia lamblia , approximately 1% of patients discontinued therapy because of an adverse event. Adverse events occurring in less than 1% of the patients age 12 years and older participating in clinical trials of Alinia Tablets are listed below: Body as a Whole: asthenia, fever, pain, allergic reaction, pelvic pain, chills, chills and fever, flu syndrome. Nervous System: dizziness, somnolence, insomnia, tremor, hypesthesia. Digestive System: vomiting, dyspepsia, anorexia, flatulence, constipation, dry mouth, thirst. Urogenital System: discolored urine, dysuria, amenorrhea, metrorrhagia, kidney pain, edema labia. Metabolic & Nutrition: increased SGPT. Hemic & Lymphatic Systems: anemia, leukocytosis. Skin: rash, pruritus. Special Senses: eye discoloration, ear ache. Respiratory System: epistaxis, lung disease, pharyngitis. Cardiovascular System: tachycardia, syncope, hypertension. Muscular System: myalgia, leg cramps, spontaneous bone fracture.
http://community.webtv.net/elmoemerson/DocElmosHepFile
http://community.webtv.net/elmoemerson/TheFamilyAlbum
Russ - 13 Jan 2006 17:19 GMT thanks for the info, interesting.
 Signature Russ http://www.tannersacre.com
> Hi Folks, the info below is from the 2005 Physician's Desk Reference (CD): > [quoted text clipped - 81 lines] > > Muscular System: myalgia, leg cramps, spontaneous bone fracture. Gordo Mondragon - 13 Jan 2006 04:44 GMT [...]
> That's an interesting question in this case. If a doctor is convinced an > already-approved-drug would be helpful where no alternatives have worked, I [quoted text clipped - 8 lines] > safety profile looks like, but assuming there weren't any grave issues using > it to this point, perhaps this could be a player within a year or so. I'd want to know what the resistance profile is like, but if I didn't have other options then I'd push for it.
G
Thip - 14 Jan 2006 13:29 GMT "Gordo Mondragon" <ga_mondragon@yahoo.com> wrote in message news:ga_mondragon-0D17BA.23401412012006@news-> I'd want to know what the resistance profile is like, but if I didn't
> have other options then I'd push for it. > > G I don't think I'd care if I puked and sat on the pot for a week straight--I'm out of options and I AM calling BCLD!
Dwight - 14 Jan 2006 22:39 GMT > "Gordo Mondragon" <ga_mondragon@yahoo.com> wrote in message > news:ga_mondragon-0D17BA.23401412012006@news-> I'd want to know what the [quoted text clipped - 6 lines] > I don't think I'd care if I puked and sat on the pot for a week > straight--I'm out of options and I AM calling BCLD! I'm right behind you Thip. Still haven't tried Infergen yet, but if something comes along that "might" even be better, I'd be willing to test it.
Dwight
Gordo Mondragon - 15 Jan 2006 03:34 GMT > "Gordo Mondragon" <ga_mondragon@yahoo.com> wrote in message > news:ga_mondragon-0D17BA.23401412012006@news-> I'd want to know what the [quoted text clipped - 5 lines] > I don't think I'd care if I puked and sat on the pot for a week > straight--I'm out of options and I AM calling BCLD! I would. I would suspect you've got a battle with any insurance company but the cost of this couldn't be more than a transplant, I don't think.
Thip - 15 Jan 2006 11:10 GMT >> "Gordo Mondragon" <ga_mondragon@yahoo.com> wrote in message >> news:ga_mondragon-0D17BA.23401412012006@news-> I'd want to know what the [quoted text clipped - 8 lines] > I would. I would suspect you've got a battle with any insurance company > but the cost of this couldn't be more than a transplant, I don't think. Gordo, my insurance covers transplants (I checked) and I should be hearing from the transplant coordinator in a few days (or so they tell me). I'd happily pay for those pills myself if it meant I could avoid it.
Thomas Wagner - 13 Jan 2006 04:54 GMT >I heard they 're using it solo as a monotherapy, or at least trying to. How >long will it take to get FDA ok? Grey, Thomas, anybody know...? I really don't know, but since it's already on the market and obviously hasn't had significant safety problems, it should sail through pretty quickly. The length of treatment might be the only problem the FDA could be concerned about - normal diarrhea treatment is probably 2-3 weeks, not 24. Anyway, 50% of genotype 4 (which is as difficult, if not more difficult to treat as geno 1) having ETR is exciting news indeed, though it's not the end of the story yet. We'll have to wait for how many it will be an SVR as well.
As greyhackles mentioned, off-label use would be a possibility today if you find a willing doc. Very small chance of any insurance picking up the tab, though, and it might be a better idea to wait a while until the initial results have been verified.
Thomas
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Doug - 13 Jan 2006 14:59 GMT >>I heard they 're using it solo as a monotherapy, or at least trying to. >>How [quoted text clipped - 15 lines] > > Thomas Thomas, thanks for the insight. I really appreciate it. Doug
Gordo Mondragon - 13 Jan 2006 04:40 GMT > This drug is on the market now for use in intestinal infections and now I > read that they have some studies that show effectiveness in HCV. A new study > is in the works. anyone know anything about it? > mc I could only find one reference, from the drug company that makes it:
"A phase II, double-blind, placebo-controlled clinical trial of Alinia as oral monotherapy in patients with chronic hepatitis C was initiated in early 2005 at the Romark Digestive Disease Research Center in Egypt. The patients were infected with HCV genotype 4. Approximately 10% of the patients had previously failed pegylated interferon and ribavirin combination therapy. 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). Importantly, the drug has been well tolerated by the patients with no significant side effects. The study is continuing with patients being followed up to evaluate the durability of response off-treatment."
This is the same dose that's used to treat intestinal parasites and the drug has been around for a few years and is still being used, so that's good news (although it's only given for 3 days.)
It's probably something they noticed, since it wasn't developed as an antiviral.
They don't say if the response started out at 100% and 50% developed resistance, or if it just doesn't work for some people from the get-go.
Interesting, thanks for the reference.
G
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