Aa
Alinia undergoing trials for Hep C
Of course, I am hopeful that my hep c will clear with regular combo therapy. However, I recently came into contact with a girl from Romark whose mother has Hep C. Romark is trials both with Alinia in conjunction with interferon alone, as a monotherapy by itself, and as an adjunct to the the combo therapy. Alinia is an already on the books drug FDA approved for treatment of giardia, which I believe is a parasitic intestinal disorder. Which means that until the FDA approves it. treatment of Hep C outside the studies would, I suppose, be off-label. I am posting this info for those who relapsed after first tx to see if anyone else has heard about this tx/drug.
http://www.romark.com/news/08152007.aspx
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/01-10-2006/0004246208&EDATE=
http://www.romark.com/news/08152007.aspx
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/01-10-2006/0004246208&EDATE=
Orleans, I think you are right...getting my geno's a fuzzy, sorry. I read somewhere it's a little easier...but maybe it's 2 that's easiest.
I think the stealth studies said type 4 had a 60% success rate (better than 1's) but that alinia increase their SVR even higher.
It's hard to keep all these studies straight in my mind anymore...but Emett Keefe I believe is the one who did the Stealth trials...at Stanford so the abstracts are out there.
one group had about 20% improvement in Svr...i'll see if I can relocate that abstract.]
mb
I think the stealth studies said type 4 had a 60% success rate (better than 1's) but that alinia increase their SVR even higher.
It's hard to keep all these studies straight in my mind anymore...but Emett Keefe I believe is the one who did the Stealth trials...at Stanford so the abstracts are out there.
one group had about 20% improvement in Svr...i'll see if I can relocate that abstract.]
mb
I think Merry mis-spoke, G-4s are not the easiest to tx, in fact they are much nearer g-1s than 3s or 2s which are eaiser to treat. jerry
I am geno 4a/c , naive , VL 100K IU/ml (3weeks ago) FibroScan F2 , FibroSure F2
got Alina sitting on my desk both generic and brand.
I understand the argument anything mono won`t work . However the mono trial
did produce a 17.4% SVR (24wk after) in a very small group with very minor Sx.
The only reason not to try it mono would be creating resistance.
Now in laboratory tests the virus did not built up resistance to Nitazoxanide
and a hepatologist @ Romark says he has no reason to believe why it
should be any different in clinical use.
My concern still is that if I do mono first and than add SOC later if mono is unsuccessful
I am not 100% conform with trial data.
Here is what a doctor @ Romark said:
Q:
Is there any reason that speaks strongly against attempting an Alinia monotherapy (geno4, <400kIU/ml) of six months first
before trying the lead in + SOC treatment at a later date (health permitting) ?
A:
This has not been formally tested, but I cannot think of any theoretical reasons why a course of Alinia monotherapy should have an impact on future combination therapy.
What bothers me is I saw some posts where geno 1s started with Alinia
mono and actually saw there VL go up from it initially.
By the way for geno 1s there will be new information from the ongoing Alinia+SOC
trials beginning 2010.
Bali05
got Alina sitting on my desk both generic and brand.
I understand the argument anything mono won`t work . However the mono trial
did produce a 17.4% SVR (24wk after) in a very small group with very minor Sx.
The only reason not to try it mono would be creating resistance.
Now in laboratory tests the virus did not built up resistance to Nitazoxanide
and a hepatologist @ Romark says he has no reason to believe why it
should be any different in clinical use.
My concern still is that if I do mono first and than add SOC later if mono is unsuccessful
I am not 100% conform with trial data.
Here is what a doctor @ Romark said:
Q:
Is there any reason that speaks strongly against attempting an Alinia monotherapy (geno4, <400kIU/ml) of six months first
before trying the lead in + SOC treatment at a later date (health permitting) ?
A:
This has not been formally tested, but I cannot think of any theoretical reasons why a course of Alinia monotherapy should have an impact on future combination therapy.
What bothers me is I saw some posts where geno 1s started with Alinia
mono and actually saw there VL go up from it initially.
By the way for geno 1s there will be new information from the ongoing Alinia+SOC
trials beginning 2010.
Bali05
I used it for over a year of my 88 week treatment along with SOC. I was UND the last 68 wks of tx, the Alinia was easily tolerated, however I did relaspe. I'm type 1a geno.
Alinia seems to help genotypes 4 quite a bit in egyptian studies, and the Stealth trials also showed promise. However, based on what happen to me I'd conclude that it may have more to do with the strength of the strain you have, as well as your own genetic predictors as to whether you clear or not with type 1. (see Newleaf's journal for genetic predictors.
Not all hep C is created equal you see. Type 4 is the weakest and has a 80-90% success rate on 6 mo. of SOC where as type 1 has only 50% SVR on 1 year of SOC.
Certainly at this point it's hard to say for certain that Alinia will help everyone, however, if I was treating again today (which I would were the PI's were available,) I don't think adding it at the front end would be a bad idea.
It is well tolerated by most.
It does seem to help knock down viral loads more quickly in most patients, and that early viral response makes treatment success more likely. If I were to treat today, I would in an ideal world do the following:
A. get the Inovio vaccine to knock out 95-99% of the virus (not likely anytime soon)
B. pretreat with antidepressants and Alinia for at least one month prior to commencement.
C. Then do a SOC lead in of one month with weight based RIba and peg or Infergen
D. Then add boceprevir after the one month LEAD IN with SOC..
E. Add the procrit somewhere in that first month before anemia becomes debilitating.
(an ounce of prevention here is worth a pound of cure. Had it been added when I was at 12 I could have functioned, at 10 I barely could, and the procrit then only kept it from dropping lower it was not able to restore a functional level to me.)
F. Stay on the tx for at least 9 months even though some are saying 6 months ought to do it.
G. make sure my blood sugars and insulin resistance is kept under perfect control the whole time, whether having recieved a type 2 diagnosis or not.
Now that's based on my type, my stage, and what my ultimate wish list would be right now based on the current science. It is subject to change any day I find out more.
mb
Alinia seems to help genotypes 4 quite a bit in egyptian studies, and the Stealth trials also showed promise. However, based on what happen to me I'd conclude that it may have more to do with the strength of the strain you have, as well as your own genetic predictors as to whether you clear or not with type 1. (see Newleaf's journal for genetic predictors.
Not all hep C is created equal you see. Type 4 is the weakest and has a 80-90% success rate on 6 mo. of SOC where as type 1 has only 50% SVR on 1 year of SOC.
Certainly at this point it's hard to say for certain that Alinia will help everyone, however, if I was treating again today (which I would were the PI's were available,) I don't think adding it at the front end would be a bad idea.
It is well tolerated by most.
It does seem to help knock down viral loads more quickly in most patients, and that early viral response makes treatment success more likely. If I were to treat today, I would in an ideal world do the following:
A. get the Inovio vaccine to knock out 95-99% of the virus (not likely anytime soon)
B. pretreat with antidepressants and Alinia for at least one month prior to commencement.
C. Then do a SOC lead in of one month with weight based RIba and peg or Infergen
D. Then add boceprevir after the one month LEAD IN with SOC..
E. Add the procrit somewhere in that first month before anemia becomes debilitating.
(an ounce of prevention here is worth a pound of cure. Had it been added when I was at 12 I could have functioned, at 10 I barely could, and the procrit then only kept it from dropping lower it was not able to restore a functional level to me.)
F. Stay on the tx for at least 9 months even though some are saying 6 months ought to do it.
G. make sure my blood sugars and insulin resistance is kept under perfect control the whole time, whether having recieved a type 2 diagnosis or not.
Now that's based on my type, my stage, and what my ultimate wish list would be right now based on the current science. It is subject to change any day I find out more.
mb
Yup, Along w/ SOC. UND @ 2weeks, 12 weeks post too. My 24 wk post is due but may put it off till after holidays. jerry
has anyone used alinia? I have been prescribed it. Previously failed standard tx twice
Very good to see you, too. Hope all is well these days with you and family.
Also good to see our friend back on here. He's a wonderful resource - and a darn good man, too.
As far as obtaining Alinia goes, I haven't looked into it. But there are all kinds of overseas/over-the-border opportunities out there. As an aside, a few years back I was able to get my Mom on an anti-dementia medication one year ahead of FDA approval, since it was already approved in Europe at that time. I found it to be relatively easy to obtain that particular drug at an on-line pharmacy and have it shipped here.
TnHepGuy
Also good to see our friend back on here. He's a wonderful resource - and a darn good man, too.
As far as obtaining Alinia goes, I haven't looked into it. But there are all kinds of overseas/over-the-border opportunities out there. As an aside, a few years back I was able to get my Mom on an anti-dementia medication one year ahead of FDA approval, since it was already approved in Europe at that time. I found it to be relatively easy to obtain that particular drug at an on-line pharmacy and have it shipped here.
TnHepGuy
just heard, on good authority, that you can get it from on=line pharmacies in Canada (though, I think, with a prescription), of very good quality, and at a much better price then here...for anyone concerned...
Hi, nice to see you. Well, a friend of mine got theirs in Mexico (another thing I'm hesitant to say) and it checked out pretty well. That's going into a pharmacy there, not online...I think they do a bang up business selling drugs to undercut drug prices here (so does Canada), so maybe they can't afford many quality control issues...When I went online to find out if I could get it from online pharmacies I found out I couldn't, but maybe I didn't know what I was doing. I don't know much about online pharmacy buying...where I'd be hesitant in buying drugs (and a few other things come to think of it) is China. Though I'm sure they are working on these issues.
To piggyback onto what willing said: many, many moons ago - before I knew any better - I was considering taking riba as a mono-tx/maintenance. This was around 1996/97 after having failed mono alpha-interferon in 1992 (and getting somewhat tired and anxious of waiting for the promised 'next miracle'). At that point riba was relatively 'new' to the combo mix and was being tested in trials. The further I looked into it the more intrigued I became - and I took it to the point of finding potential suppliers in Europe and Canada where I could purchase it for import. But the more I learned, the more concerned I became about the potential for viral variants/resistance if I were to do riba as mono. And so that was the end of that.
The point of my little story is that Alinia, too, is out there and available, should you so desire - be it Mexico, Canada or Europe. I guess one of the biggest concerns in ordering it, though, would be in somehow trying to ascertain that you are receiving the real McCoy - and not the Alinia equivalent of baby laxative.
TnHepGuy
The point of my little story is that Alinia, too, is out there and available, should you so desire - be it Mexico, Canada or Europe. I guess one of the biggest concerns in ordering it, though, would be in somehow trying to ascertain that you are receiving the real McCoy - and not the Alinia equivalent of baby laxative.
TnHepGuy
I just found out that the company that has Alinia, isn't really picky about it's form for getting it (as a financial hardship case) Hesitate to throw that out there, but this is a very serious situation, and sometimes we have to do what we have to do.
HR : thanks for your thoughts on this; in fact the cognitive disorders, particularly poor-memory, associated with both untreated hcv and tx are a standing joke around here (makes one wonder whether Alberto Gonzales shouldn't be going in for an hcv test).
In light of that paper, perhaps both are at least in part due to ifn-induced phosphorylation of eIF2-alpha's Ser-51. The existence of a connection between such a fundamental cog in translational machinery and higher level brain function seems absolutely astounding to me!
I don't understand your comment about the "totally independent nature" of NTZ's mechanism: inhibition of eIF2-alfa dephosphorylation seems more complementary-to than independent-of ifn's action on that IF (I assumed that was part of why the non-naive results didn't look so great). Also, with regards to viral mutation, it'll be interesting to see what sort of NTZ resistance is reported, but I'm betting against the virus on this one. The ribosome is an ancient and very-conserved bit of machinery and no matter how adaptable the virus there's relatively little negotiating room if it wants to get its proteins translated. The Robert'06 study linked above seems to indicate that HCV has access to a "non-standard" way of binding eIF2-alpha (ie without the eIF2-alpah-GTP-Met-tRNA-Met TC complex) but presumably it still needs unphosphorylated eIF2 to get the job done.
ForeSee : yes, thanks-you! I'll be in touch. Sounds like you've got a good plan. For what it's worth, and I hope somebody proves me wrong if I'm off base on this, but I've never been much of a believer in developing ifn-resistance through tx. The ifn response is just too multi-faceted for the virus to wriggle out of, as it can with a single mutation in the case of vx. As far as I can tell, people have been poring over sequences of patients for whom tx did/didn't work for years now and haven't found anything convincing yet.
Gauf: if you decide to go that route it might be worth trying online pharmacies in Mexico/Canada. I found out a while back riba is apparently available over-the-counter in Mexico.
In light of that paper, perhaps both are at least in part due to ifn-induced phosphorylation of eIF2-alpha's Ser-51. The existence of a connection between such a fundamental cog in translational machinery and higher level brain function seems absolutely astounding to me!
I don't understand your comment about the "totally independent nature" of NTZ's mechanism: inhibition of eIF2-alfa dephosphorylation seems more complementary-to than independent-of ifn's action on that IF (I assumed that was part of why the non-naive results didn't look so great). Also, with regards to viral mutation, it'll be interesting to see what sort of NTZ resistance is reported, but I'm betting against the virus on this one. The ribosome is an ancient and very-conserved bit of machinery and no matter how adaptable the virus there's relatively little negotiating room if it wants to get its proteins translated. The Robert'06 study linked above seems to indicate that HCV has access to a "non-standard" way of binding eIF2-alpha (ie without the eIF2-alpah-GTP-Met-tRNA-Met TC complex) but presumably it still needs unphosphorylated eIF2 to get the job done.
ForeSee : yes, thanks-you! I'll be in touch. Sounds like you've got a good plan. For what it's worth, and I hope somebody proves me wrong if I'm off base on this, but I've never been much of a believer in developing ifn-resistance through tx. The ifn response is just too multi-faceted for the virus to wriggle out of, as it can with a single mutation in the case of vx. As far as I can tell, people have been poring over sequences of patients for whom tx did/didn't work for years now and haven't found anything convincing yet.
Gauf: if you decide to go that route it might be worth trying online pharmacies in Mexico/Canada. I found out a while back riba is apparently available over-the-counter in Mexico.
Actually, if I lost all memory of events prior to 1987 or so, I would consider that a real plus! Anyway, I have read all I can find on this (not much yet); looks almost too good to be true. So many disappointments thus far with tx. BUT, it seems relatively safe and the risk to reward ratio for heppers in my position... well, I will run my own little study if i can I can get it in time!
-Geof
-Geof
MEDICAL PROFESSIONAL
re the cell paper re blockage of the elongation factor and long term memory problems:
It should be enough of a concern to require psychometric testing in the US trials to show if such effect would exist in humans at the dosage used.
The effect if any does not seem strong enough to be obvious. Given that it would likely be temporary ( since rapid protein synthesis seems required for LT memory), this is a dynamic process that can be turned on or off and the drug disappears rapidly from the circulation - hence twice a day dosing.
Even if mildy present it might not be a real problem due to the temporary nature.
We can speculate, that the virus requires rapid synthetic activity more than the host and is therefore selectively impeded. The totally independent nature of this particular impediment to viral reproduction makes it likely to provide a truly synergistic effect with other treatment modalities.
I dont think there was any reason to do the 12wk monophase with NTZ other than to see its monopotential.Maybe there was hope for a stronger mono effect , that could strengthen the position in a future partnership. It would be very interesting to see a real from the start combotrial.
While NTZ blocks a host function, resistance is still possible by viral mutations reducing the reliance on such host function. This can only be tested, not reasonable predicted, like the quick resistance to nonnucleoside Polymerase inhibitors.
On a lighter note, consider the potential benefits of this memory effect in the combo: "How bad was your SOC Alinia combo treatment"? Patient: " As far as I remember, no problems, really".
It should be enough of a concern to require psychometric testing in the US trials to show if such effect would exist in humans at the dosage used.
The effect if any does not seem strong enough to be obvious. Given that it would likely be temporary ( since rapid protein synthesis seems required for LT memory), this is a dynamic process that can be turned on or off and the drug disappears rapidly from the circulation - hence twice a day dosing.
Even if mildy present it might not be a real problem due to the temporary nature.
We can speculate, that the virus requires rapid synthetic activity more than the host and is therefore selectively impeded. The totally independent nature of this particular impediment to viral reproduction makes it likely to provide a truly synergistic effect with other treatment modalities.
I dont think there was any reason to do the 12wk monophase with NTZ other than to see its monopotential.Maybe there was hope for a stronger mono effect , that could strengthen the position in a future partnership. It would be very interesting to see a real from the start combotrial.
While NTZ blocks a host function, resistance is still possible by viral mutations reducing the reliance on such host function. This can only be tested, not reasonable predicted, like the quick resistance to nonnucleoside Polymerase inhibitors.
On a lighter note, consider the potential benefits of this memory effect in the combo: "How bad was your SOC Alinia combo treatment"? Patient: " As far as I remember, no problems, really".
Try to find a friendly, "open minded" doc that will prescribe you Alinia. It's a relatively innocuous drug so that shouldn't be too difficult.
Kittyface
Kittyface
I would only use it as a suplemental to the combo prescribed. Hope I can find a way to get it. I cannot change docs again...I just finally got to see a real Hepatologist. Thank you for the blessing and back at you.
You wouldn't want to do Alinia as mono-tx - unless you are thinking of using it strictly in a maintenance application (of which there is zero information out there, so you'd truly be swimming alone). The concern with any mono-tx is the potential for resistant viral variants to arise (perhaps HR and/or willing could better address this possibility w/ Alinia), therefore rendering the drug possibly useless for you to use in a future combo tx. If you are attempting viral eradication w/ a goal of SVR, it would probably be best to place Alinia into a combo tx setting.
Given you circumstances - and failed tx history - you need to educate your current doc on the ongoing Alinia trials and tell him just how interested you are in it. Or, consider finding a new doc who would be more 'open' to experimentation (alot easier said-than-done, of course).
May God's blessings and mercy be upon you.
TnHepGuy
Given you circumstances - and failed tx history - you need to educate your current doc on the ongoing Alinia trials and tell him just how interested you are in it. Or, consider finding a new doc who would be more 'open' to experimentation (alot easier said-than-done, of course).
May God's blessings and mercy be upon you.
TnHepGuy
Hey, according to our mutual friend, you need some info...feel free to contact me through my profile...be well...hey, and thanks for the document I'm faxing this to my doc...
As a 3a and 2x relapser with cirrhosis, I would be willing to try almost anything relatively safe and promising. I have got to clear next treatment as I am running out of time. I cannot wait for teleprevir. Now, Alinia is sitting out there and has few sides and looks promising, but I don't have parasites, so how to get a hold of it? My hep guy would never go for it, but it is MY decision. It is frustrating to see hope for us around the corner, but some of us can't wait that long. You bet I will take Alinia if I can figure out a way to get my hands on it!!
I put you on there too, but the name block doesn't register everyone after a certain point, hope youre feeling better too! some more seafaring journals please!
That's why, after all of this, I'm willing to try treatment, knowing, that I might not get rid of this fatigue, and all the pitfalls. But I'm taking a risk that clearing up the virus might give me that ultimate energy (at least some of it back.) Though I'm not putting a lot into "expectations" a fools errand I know. Expectations can kick you in the a$$ big time, so I'm just hoping for "better." Even though I know there's a chance that I may be worse in the fatigue dept.
Something I wrote on another thread, thanks soooo much for your concern guys, but I think what I'm doing is going to be okay...I am trying to get in the next Vertex trial, see if I can...still awaiting a response from the trial coordiantor, she got a little pssed that I didn't go into to the last trial, so I'm hoping she doesn't think I'll flake on her, etc...it's bad that we have to still count on people and their prejudices for such major decisions, etc...love you guys...
Something I wrote on another thread, thanks soooo much for your concern guys, but I think what I'm doing is going to be okay...I am trying to get in the next Vertex trial, see if I can...still awaiting a response from the trial coordiantor, she got a little pssed that I didn't go into to the last trial, so I'm hoping she doesn't think I'll flake on her, etc...it's bad that we have to still count on people and their prejudices for such major decisions, etc...love you guys...
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