Aa
Alinia trial results at 2010 EASL (on CCO)
CCO has posted (April 18) results of an Alinia trial reported at the 2010 EASL conference. The results don't look too promising (granted that the subjects were all previous non-responders). But is this the same study (and same results) that came out previously? They don't state when the trial being reported was done. Very confusing. Is this Romark just trying to keep their name in the news? CCO puffing up their reports? Or real news? It's anyone's guess.
Thanks, Romark, CCO, and the medical profession (this means you, all you quacks, pill-pushers, saw-bones, and self-righteous suborned confessed pharma-consultants), for once again helping us hep C infectees out with all this useful data (yes, I am being sarcastic). Tens of millions of people with geno 1 are grasping at straws, we want to take Alinia if it works, and gee, Nitazoxanide is such a cool-sounding word it must do something good, huh? But... does it work?
Nobody knows. Nobody can figure out how to test it. We're up the proverbial creek without the proverbial paddle.
So, what else is new?
Mike
Thanks, Romark, CCO, and the medical profession (this means you, all you quacks, pill-pushers, saw-bones, and self-righteous suborned confessed pharma-consultants), for once again helping us hep C infectees out with all this useful data (yes, I am being sarcastic). Tens of millions of people with geno 1 are grasping at straws, we want to take Alinia if it works, and gee, Nitazoxanide is such a cool-sounding word it must do something good, huh? But... does it work?
Nobody knows. Nobody can figure out how to test it. We're up the proverbial creek without the proverbial paddle.
So, what else is new?
Mike
I'm terminally depressed on the whole subject, Merry. The gov isn't gonna let anything pass that cuts into their stock profits. And things are gonna get worse before they get any better.
Down here in the Southern Hemisphere the illicit profits and corruption are less, but at this point in the globalization of evil there's nowhere to hide.
Mike
Down here in the Southern Hemisphere the illicit profits and corruption are less, but at this point in the globalization of evil there's nowhere to hide.
Mike
PPC is here now, and can at least slow things down for you Mike.
Electraporation is here now...that's just a delivery machine...and since it works by delivering drugs within the cell wall, it should not take as long to implement it. It should work on a variety of drugs that have trouble permeating cell walls...not just the hcv vaccine, but Riba which takes months to penetrate, and other drugs as well.
In theory the machine would be safer than the one day pills they are working on.
The one day pills are promising until you read the black box info., and then they give us pause.
If Sweden can build upteen thousands of Volvo's every year, they could sure enough gear up and get those machine built if they have the will to do it.
If one could get a 2 or yes a 10 log drop in a day ....it would make sense to think the SOC could be shortened by 2 to 6 months perhaps, and this would allow sides and disability to be severely curtailed. Many folks who can't take a year of tx could retreat, and get better results on 8 months than they got on 12, in theory.
Of course in my perfect world docs would also do the Riba blood level tests they should have been doing all along...chorkle.
The issue is going to be whether the doctors and big Pharm will ever let it happen.
If you knock out 98% of virun in a day, that means tx can be shortened, and that hits everyones bottom line...hate to sound so cynical...but don't hold your breath.
I can just see the board rooms cringing at the idea that everyones treatment plan would now be 10K cheaper...multiply that by a few million treaters (700 million worldwide)
yeah, so this will get the fast track...not.
Electraporation is here now...that's just a delivery machine...and since it works by delivering drugs within the cell wall, it should not take as long to implement it. It should work on a variety of drugs that have trouble permeating cell walls...not just the hcv vaccine, but Riba which takes months to penetrate, and other drugs as well.
In theory the machine would be safer than the one day pills they are working on.
The one day pills are promising until you read the black box info., and then they give us pause.
If Sweden can build upteen thousands of Volvo's every year, they could sure enough gear up and get those machine built if they have the will to do it.
If one could get a 2 or yes a 10 log drop in a day ....it would make sense to think the SOC could be shortened by 2 to 6 months perhaps, and this would allow sides and disability to be severely curtailed. Many folks who can't take a year of tx could retreat, and get better results on 8 months than they got on 12, in theory.
Of course in my perfect world docs would also do the Riba blood level tests they should have been doing all along...chorkle.
The issue is going to be whether the doctors and big Pharm will ever let it happen.
If you knock out 98% of virun in a day, that means tx can be shortened, and that hits everyones bottom line...hate to sound so cynical...but don't hold your breath.
I can just see the board rooms cringing at the idea that everyones treatment plan would now be 10K cheaper...multiply that by a few million treaters (700 million worldwide)
yeah, so this will get the fast track...not.
The answer is that Alinia is available now, whereas the others aren´t available (and may never be).
what I'm also wondering is why there's so little discourse on other more promising new drugs right on the horizon. Debio 025, other inhibitors, and the other 20 or so currently showing promise....and in many cases far more promise than Alinia.
Hey there, sorry I didn't see your ?? until now, up to my elbows in home reno right now.
I see how unclear I was..ok, here's the issue as I see it...yes they lead in with the alinia...but that's not what I think needs to happen, the real lead in we need to focus on is how to get the non-absorbable drugs into absorbable forms and into the blood in2 days not 2 months!!!!.
The key became obviobvious when I saw the difference between the PI results for boceprevir vs. teleprevir. One allowed Riba to build before the PI punch, one did not, this then lead me to all sorts of other pet theories I'd been working on which led to some conclusions. It deals of course with the mutation rates and why the SVR rates are so low, and quite frankly everything points to that 72 hour window, meaning VEVR should be the goal.
To that end we don't just need Alinai, we need to hit this virus from every side with every means possible.
I'm inclined to think that the hydrophobic cells are a key factor and that we could use dialysis to remove virus followed by electraporation with Inoivio's vaccine (these 2 would remove 99.99% of the virus in ONE DAY... followed by electraporation to infuse Riba IN and permeate those resistant membranes...I'd add PPC for the same reason, to help get riba in,, AND I'd lower lower insulin by whatever means to enhance the INF AND I'd then hit the Alinia and the Infergen every 8 hrsby injection, not 12, and not the PEG?INF as it's not as relieble for plasma levels.
In other words in a perfect world one would not just hit or miss this or that, but raise levels of all drugs to optimal levels and do it in a 24-48 hour period as the window before mutation becomes the issue is only 72 hours...which of course no one wants to talk about. Of course my treatment wishlist is ever evolving based on the science.
I'f you want to discuss all this privately it would perhaps be best.
Not wanting to scare anyone, just saying there's lot of ways to approach this, we need to approach it with the goal being 99% effective, not just hey, add this and chances go up from 50 to 55%..whoopdeedo...not.
My take, having relasped in spite of and with supreme effort no to, would be to go nuclear next time around and that will involve using every weapon at our disposal. I'd use napam (rotinivir) or Bristol-1 even, although I would perfer the electropolation to get the riba up if that becomes available as the other way is more toxic.
Look, I'm not opposed to Alina if it works, and you are right the African addition made the study harder, and that's a good point...I just don't like the way they equated this small study with overall conclusions.
I've participated in studies myself. Often folks in studies are more compliant, they are getting more feedback, they take their duty to the study seriously. They know their results may help others. The Egyptian study had a VERY motivated doctor and he made sure he had complete compliance. The down side then is that the numbers don't reflex well the true result. Why? Because, if you had complete compliance in the general treating populace you would also see a bump of 5-10%. You don't see that because folks aren't all compliant. The sides are so great people skip dosages...heck...I've even heard people in here tell others 80% of dosing is OK.
It's not, but you well know how these things effect outcomes.
Ergo I'm just saying I'm not convinced, not saying it might not help, just saying that a 5% bump is hardly convincing.
I think we should be discussing PPC, if you look at studies where children with LD (and motivated parents dosing them) had results that were stellar across the board, I think some arguments could be made for dosing things that allow for better hepatic penetration and we need to look at the products that do this first and formost such as PPC, R-ALA etc etc etc..
Just my opinion, I could be wrong, but there are several hundred pubmed studies now that indicate that changing the whole glutathione methylation profile is key not only to oxidative relief and fibrotic prevention/reversals but ALSO to the actual way the drug therapies work (or don't work) to begin with.
When I came into this forum one person mentioned fat would help Riba absorb...well let's take that to the next level shall we....why is that, and what fat does that best, and why is this so impotant. No one explained that to me, I wish they had,
The trouble with current SOC is even though they know the window is 72 hours they are still sticking with an arachic delivery system that assures failure in half the G1's and adds to the chances of superstrains. Why nobody is paying attention to electrporation is beyond me. But then, noone is paying attention to IPT therapy either, and there you see 50% bumps in success rate. It goes to show that mainstream medicals are generally 50 years behinds the Pasteurs and the Salks of the world. Very few think outside of the box.
(It's PPC by the way, just as HR said it was that aides riba's effects. Wish more of us had paid attention to his input. Why would some board members harass a leading researcher in the field....that was beyond me. )
PM me if you wnat to about all this....I'd love to pick your brain.
merrybe
I see how unclear I was..ok, here's the issue as I see it...yes they lead in with the alinia...but that's not what I think needs to happen, the real lead in we need to focus on is how to get the non-absorbable drugs into absorbable forms and into the blood in2 days not 2 months!!!!.
The key became obviobvious when I saw the difference between the PI results for boceprevir vs. teleprevir. One allowed Riba to build before the PI punch, one did not, this then lead me to all sorts of other pet theories I'd been working on which led to some conclusions. It deals of course with the mutation rates and why the SVR rates are so low, and quite frankly everything points to that 72 hour window, meaning VEVR should be the goal.
To that end we don't just need Alinai, we need to hit this virus from every side with every means possible.
I'm inclined to think that the hydrophobic cells are a key factor and that we could use dialysis to remove virus followed by electraporation with Inoivio's vaccine (these 2 would remove 99.99% of the virus in ONE DAY... followed by electraporation to infuse Riba IN and permeate those resistant membranes...I'd add PPC for the same reason, to help get riba in,, AND I'd lower lower insulin by whatever means to enhance the INF AND I'd then hit the Alinia and the Infergen every 8 hrsby injection, not 12, and not the PEG?INF as it's not as relieble for plasma levels.
In other words in a perfect world one would not just hit or miss this or that, but raise levels of all drugs to optimal levels and do it in a 24-48 hour period as the window before mutation becomes the issue is only 72 hours...which of course no one wants to talk about. Of course my treatment wishlist is ever evolving based on the science.
I'f you want to discuss all this privately it would perhaps be best.
Not wanting to scare anyone, just saying there's lot of ways to approach this, we need to approach it with the goal being 99% effective, not just hey, add this and chances go up from 50 to 55%..whoopdeedo...not.
My take, having relasped in spite of and with supreme effort no to, would be to go nuclear next time around and that will involve using every weapon at our disposal. I'd use napam (rotinivir) or Bristol-1 even, although I would perfer the electropolation to get the riba up if that becomes available as the other way is more toxic.
Look, I'm not opposed to Alina if it works, and you are right the African addition made the study harder, and that's a good point...I just don't like the way they equated this small study with overall conclusions.
I've participated in studies myself. Often folks in studies are more compliant, they are getting more feedback, they take their duty to the study seriously. They know their results may help others. The Egyptian study had a VERY motivated doctor and he made sure he had complete compliance. The down side then is that the numbers don't reflex well the true result. Why? Because, if you had complete compliance in the general treating populace you would also see a bump of 5-10%. You don't see that because folks aren't all compliant. The sides are so great people skip dosages...heck...I've even heard people in here tell others 80% of dosing is OK.
It's not, but you well know how these things effect outcomes.
Ergo I'm just saying I'm not convinced, not saying it might not help, just saying that a 5% bump is hardly convincing.
I think we should be discussing PPC, if you look at studies where children with LD (and motivated parents dosing them) had results that were stellar across the board, I think some arguments could be made for dosing things that allow for better hepatic penetration and we need to look at the products that do this first and formost such as PPC, R-ALA etc etc etc..
Just my opinion, I could be wrong, but there are several hundred pubmed studies now that indicate that changing the whole glutathione methylation profile is key not only to oxidative relief and fibrotic prevention/reversals but ALSO to the actual way the drug therapies work (or don't work) to begin with.
When I came into this forum one person mentioned fat would help Riba absorb...well let's take that to the next level shall we....why is that, and what fat does that best, and why is this so impotant. No one explained that to me, I wish they had,
The trouble with current SOC is even though they know the window is 72 hours they are still sticking with an arachic delivery system that assures failure in half the G1's and adds to the chances of superstrains. Why nobody is paying attention to electrporation is beyond me. But then, noone is paying attention to IPT therapy either, and there you see 50% bumps in success rate. It goes to show that mainstream medicals are generally 50 years behinds the Pasteurs and the Salks of the world. Very few think outside of the box.
(It's PPC by the way, just as HR said it was that aides riba's effects. Wish more of us had paid attention to his input. Why would some board members harass a leading researcher in the field....that was beyond me. )
PM me if you wnat to about all this....I'd love to pick your brain.
merrybe
evangelin : thanks for the good wishes - I emailed my Dr. today with a proposed plan and will be seeing him Monday - we'll see. As I understand it NTZ, like RBV increases effectiveness of IFN. If Joe will try again after release of one of the 1st-gen PIs it's probably worth adding it back to the mix. Of course the ideal would be for him to benefit from two antivirals with different targets - thus minimizing the need for ifn, but that's still a few years out. Anyway, all the best to both of you (and about the brainy comments you must be thinking of GD; me I'm still trying to sort out what Trin's hummingbirds are going to do after she takes all their toilet paper out of her trees).
MerryBe: uh- sorry but I'm not following you again . The study linked
http://www.kenes.com/easl2010/Posters/Abstract130.htm
provides "VRVR, RVR, early virologic response (EVR), End Treatment Response(ETR) and Sustained Viral response(SVR) in naïve patients with chronic hepatitis C genotype 1 (GT1)" thus not restricted to EVR and clearly targets G1s. Also the fact that they went after an admittedly tough-to-treat crowd (21% Black and mean BMI 27.9) makes their results look better, not worse. Since the drug is already in use I assume there was no FDA requirement to run a placebo arm. And, again, have a look at the reported relapse rate.
MerryBe: uh- sorry but I'm not following you again . The study linked
http://www.kenes.com/easl2010/Posters/Abstract130.htm
provides "VRVR, RVR, early virologic response (EVR), End Treatment Response(ETR) and Sustained Viral response(SVR) in naïve patients with chronic hepatitis C genotype 1 (GT1)" thus not restricted to EVR and clearly targets G1s. Also the fact that they went after an admittedly tough-to-treat crowd (21% Black and mean BMI 27.9) makes their results look better, not worse. Since the drug is already in use I assume there was no FDA requirement to run a placebo arm. And, again, have a look at the reported relapse rate.
I totally agree. Romark is fudging their test results. No clarity. It's a shame, because nitazoxanide probably does do some good. But they are not creating confidence with all these confusing and contradictory results. They have made such a hash of the lead-in-time question (Alinia first? Ribavirin first?) that everyone's fed up with the subject.
The PI trial results are also being obfuscated, I fear. They're claiming 80% SVR for geno 1s, but it looks more like 60%-70% to me, and it's still too soon to tell just how sustained the response really is. (Now a whole slew of forum members are gonna get on my case for knocking the PIs again, as if I were the cause of the problems with them {grin}.)
It'll be a poor joke if it turns out that the new SVRs with the PIs are false, and that it's just the escape variants not being triggered by the PCR primers. Which is the spooky thing about Riba/Interferon (viz HIV).
You'd think the people publishing articles and running conferences would impose higher standards, but...what can we expect? Science went down the drain long ago. (Okay, now you can jump on my head and call me "negative" and a "pessimist", all you goody-two-shoes out there.)
M.
The PI trial results are also being obfuscated, I fear. They're claiming 80% SVR for geno 1s, but it looks more like 60%-70% to me, and it's still too soon to tell just how sustained the response really is. (Now a whole slew of forum members are gonna get on my case for knocking the PIs again, as if I were the cause of the problems with them {grin}.)
It'll be a poor joke if it turns out that the new SVRs with the PIs are false, and that it's just the escape variants not being triggered by the PCR primers. Which is the spooky thing about Riba/Interferon (viz HIV).
You'd think the people publishing articles and running conferences would impose higher standards, but...what can we expect? Science went down the drain long ago. (Okay, now you can jump on my head and call me "negative" and a "pessimist", all you goody-two-shoes out there.)
M.
I didn't have time to really read the above posts but I remember reading earlier today that you were considering Alinia and SOC for a retry. Joe tried it after 2 previous TX failures and although he didn't clear, he came much closer than he did the first two times with just plain SOC. The first two failures, he was stopped at 13 weeks because he hadn't even had a 2 log drop. With Alinia added, he did have a good 2 log drop by 12 wks. but unfortunately, his viral load stalled in the low hundreds and wouldn't budge. He tried for 15 months and finally had to quit. My point is, it got a non-responder a better response than he ever had prior so maybe it will be just what you need to finish the job. Did you ever read what CS did to finally SVR after 2 previous failures? SamE, TMG B12 and folic acid were part of his tactics and it worked this time. He had quite a lot of research to back up his reasoning and it is hard to argue with his success. He tried to take Alinia but it caused him too much diarrhea and he had to stop it. Joe had trouble with that too but lots of others don't seem to. Joe never stopped taking it but he would have liked to. I know someone else that took it and had absolutely no SX at all.
I wish you well and always look forward to your brainy comments:>)
Ev
I wish you well and always look forward to your brainy comments:>)
Ev
I can see now why confusion got in there....we were discussing alinia initially, but it bled into the other PI's.
Bottom line is this, the new PI's will work better with lead-ins, it's a measurably better SVR result. Teleprevir with lead-in should more closely approximate the boceprvir results IMHO.
as to Alinia, well yes they used lead in in the study you gave Willing, but here's the rub.
first, a lead in is great if it helps in the end. the stats show the phase 2 studies gave better VEVR etc but it didn't really translate into better SVR's in the end.
also the study is skewed. For one thing, your study had 23 patients only.
For another it is harldly a cross section of the average geno 1's, unless 25% of geno 1's are black, which they aren't.
For another they state the overall cure as 46%...low and incorrect for type 1.
If we factor the true number of minorities we get very different numbers. Each study should be taylored to represent the true ratio's for that genotype worldwide, otherwise we get skewed results. At this point, since we know now that genetics are a factor, it would help africans to know what they can expect apart from other races. Folks with genetic disadvantages should know what their odds really are, not what they are when adding people without that handicap are factored in.
I was on board with the Alinia excitement initially...but in retrospect I think they leave out some important info....
example:
here's a blip from one of their press releases:
.........Front-runner Vertex Pharmaceuticals of Cambridge, Mass., reported its experimental compound, telaprevir, eliminated the hepatitis C virus in 61 percent of patients. Alinia, meanwhile, had been successful in 79 percent of its Egyptian patients. Both companies tested their drugs in conjunction with the current hepatitis C treatment of interferon and ribavirin. The standard treatment has a success rate of just 40 to 50 percent. <<<<<<<<<<<<<
WRONG....totally wrong!!
OK, reading that, I would assume that they have upped the results by 30% on Alinia...but on closer examination let's look at some facts...for one thing, geno type 4 has a higher SOC success rate, not 50% as stated (that's geno1) and geno 4 is closer to 60% naturally.
Notice no mention was made of genotypes whatsoever in that clip???
For another thing, the slight rise in geno 4 results could have been due to adherance rather than the drug. If you tack on 10-15% better result for adherance, that means the Alinia gave a 5-10% bump at best.
I know how the study was done...this doctor hand picked very motivated immigrants to egypt, without any other way of ever treating and then he suppervised them relentlessly to get 100% compliance. 100% compliance with the INF/Riba regime always produces better results than 80 or 90% compliance, we do know this
Furthermore O'keefe at Stanford has not been able to get numbers to get very excited about.
plus if you reread the clip I just gave, you can see they are trying to tie their drug in with PI's that actually work, and trying to cojoin genotype 4 and 1 results...as if that will pass muster in any save a naive patient...info challenged that is.... I smell a rat.
The cross section they used for the study (the 23 patients) fit more closely a cross section of geno 4's, but even if that was their goal they fell short, since a truer result would be if you placed middle easterners into the caucasian slot. That would then refect the type 4 populace.
Mind you, whether we speak of type 1, 4 , 2 or 3, I'm not opposed to adjunct that actually do improve over SVR. But mixing apples with oranges when strains vary greatly in their responses hardly seems the way to go.
Also, I'm not buying the small lab theory, a small lab still knows that they need double blinds AND accurate stats AND refective populace AND that they shouldn't mix information from 2 different genotypes when touting the efficacy of their product.
JUst to be devils advocate here, I could probaly get a VEVR by taking extra zinc or vitamin C or any number of other compounds, including chicken soup...anything that temporarily lowers viral load or boost interferon (now that we can measure virons down to parts per million) could give an early of very early viral response....that does not however mean it will translate into actual cures at days end and THAT is the high water mark.
final remark, did you notice that the heading for that study was SVR for ALL genotypes"
yet further on they mention only treating GT1's....
can they make it more confusing? Either you are studing all geno's or just 1 genotype.
since the study can't seem to make up it's mind, I suggest we not make up ours either.
It is certainly in Romarks interest to sell what was a 10 dollar drug to the hcv community for 1000 a month, the question is, have they proved this works, or are we just seeing another Benny Hinn moment, a white Armani suit waving in the breeze and claiming to heal people without any real result and no palpable proofs.
Bottom line is this, the new PI's will work better with lead-ins, it's a measurably better SVR result. Teleprevir with lead-in should more closely approximate the boceprvir results IMHO.
as to Alinia, well yes they used lead in in the study you gave Willing, but here's the rub.
first, a lead in is great if it helps in the end. the stats show the phase 2 studies gave better VEVR etc but it didn't really translate into better SVR's in the end.
also the study is skewed. For one thing, your study had 23 patients only.
For another it is harldly a cross section of the average geno 1's, unless 25% of geno 1's are black, which they aren't.
For another they state the overall cure as 46%...low and incorrect for type 1.
If we factor the true number of minorities we get very different numbers. Each study should be taylored to represent the true ratio's for that genotype worldwide, otherwise we get skewed results. At this point, since we know now that genetics are a factor, it would help africans to know what they can expect apart from other races. Folks with genetic disadvantages should know what their odds really are, not what they are when adding people without that handicap are factored in.
I was on board with the Alinia excitement initially...but in retrospect I think they leave out some important info....
example:
here's a blip from one of their press releases:
.........Front-runner Vertex Pharmaceuticals of Cambridge, Mass., reported its experimental compound, telaprevir, eliminated the hepatitis C virus in 61 percent of patients. Alinia, meanwhile, had been successful in 79 percent of its Egyptian patients. Both companies tested their drugs in conjunction with the current hepatitis C treatment of interferon and ribavirin. The standard treatment has a success rate of just 40 to 50 percent. <<<<<<<<<<<<<
WRONG....totally wrong!!
OK, reading that, I would assume that they have upped the results by 30% on Alinia...but on closer examination let's look at some facts...for one thing, geno type 4 has a higher SOC success rate, not 50% as stated (that's geno1) and geno 4 is closer to 60% naturally.
Notice no mention was made of genotypes whatsoever in that clip???
For another thing, the slight rise in geno 4 results could have been due to adherance rather than the drug. If you tack on 10-15% better result for adherance, that means the Alinia gave a 5-10% bump at best.
I know how the study was done...this doctor hand picked very motivated immigrants to egypt, without any other way of ever treating and then he suppervised them relentlessly to get 100% compliance. 100% compliance with the INF/Riba regime always produces better results than 80 or 90% compliance, we do know this
Furthermore O'keefe at Stanford has not been able to get numbers to get very excited about.
plus if you reread the clip I just gave, you can see they are trying to tie their drug in with PI's that actually work, and trying to cojoin genotype 4 and 1 results...as if that will pass muster in any save a naive patient...info challenged that is.... I smell a rat.
The cross section they used for the study (the 23 patients) fit more closely a cross section of geno 4's, but even if that was their goal they fell short, since a truer result would be if you placed middle easterners into the caucasian slot. That would then refect the type 4 populace.
Mind you, whether we speak of type 1, 4 , 2 or 3, I'm not opposed to adjunct that actually do improve over SVR. But mixing apples with oranges when strains vary greatly in their responses hardly seems the way to go.
Also, I'm not buying the small lab theory, a small lab still knows that they need double blinds AND accurate stats AND refective populace AND that they shouldn't mix information from 2 different genotypes when touting the efficacy of their product.
JUst to be devils advocate here, I could probaly get a VEVR by taking extra zinc or vitamin C or any number of other compounds, including chicken soup...anything that temporarily lowers viral load or boost interferon (now that we can measure virons down to parts per million) could give an early of very early viral response....that does not however mean it will translate into actual cures at days end and THAT is the high water mark.
final remark, did you notice that the heading for that study was SVR for ALL genotypes"
yet further on they mention only treating GT1's....
can they make it more confusing? Either you are studing all geno's or just 1 genotype.
since the study can't seem to make up it's mind, I suggest we not make up ours either.
It is certainly in Romarks interest to sell what was a 10 dollar drug to the hcv community for 1000 a month, the question is, have they proved this works, or are we just seeing another Benny Hinn moment, a white Armani suit waving in the breeze and claiming to heal people without any real result and no palpable proofs.
I've got to find more time to study the test results, it seems. Many thanks for the heads-up!
Mike
Mike
kittyface: thanks
merryBe,mike: am having a hard time following your criticisms as one of the trials linked above clearly included a lead-in:
"All received NTZ 500 mg bid - first 2 weeks; RBV 800 mg(AM) + 600 mg(night) added to NTZ for next 2 weeks; subcutaneous PegIFN alfa-2a 180 mcg weekly added to RBV and NTZ at the same dose for next 12 weeks. "
from
http://www.kenes.com/easl2010/Posters/Abstract130.htm
I thought the results were pretty impressive given the baseline stats. Note also that though they had a couple of breakthroughs between w24 and EOT the relapse rate was 0
ALL 13 who were UND at EOT got to stay that way.
Looks like a pretty compelling argument for considering this as an add-on for any relapser, w or w/o a PI.
merryBe,mike: am having a hard time following your criticisms as one of the trials linked above clearly included a lead-in:
"All received NTZ 500 mg bid - first 2 weeks; RBV 800 mg(AM) + 600 mg(night) added to NTZ for next 2 weeks; subcutaneous PegIFN alfa-2a 180 mcg weekly added to RBV and NTZ at the same dose for next 12 weeks. "
from
http://www.kenes.com/easl2010/Posters/Abstract130.htm
I thought the results were pretty impressive given the baseline stats. Note also that though they had a couple of breakthroughs between w24 and EOT the relapse rate was 0
ALL 13 who were UND at EOT got to stay that way.
Looks like a pretty compelling argument for considering this as an add-on for any relapser, w or w/o a PI.
I'll throw in my anecdotal two cents. Alinia plus SOC equalled SVR for me. I was geno 1a, 80 million VL and diabetic (caused by HCV) which are all negative indicators for SVR. I went UND at 5 weeks and did 48 weeks.
Comparing Alinia sx's to those of IFN/Riba are like comparing a lamb to a T-Rex. It is expensive but with a little creativity and an open minded doctor it is possible to defray some costs. I received it for free along with Pegasys and Copegasys.
It is my firm belief that adding Alinia to the mix greatly increases SVR odds while producing negligible sx. And there doesn't seem to be any lasting effects. Most of my complaints are SOC related.
Kittyface
Comparing Alinia sx's to those of IFN/Riba are like comparing a lamb to a T-Rex. It is expensive but with a little creativity and an open minded doctor it is possible to defray some costs. I received it for free along with Pegasys and Copegasys.
It is my firm belief that adding Alinia to the mix greatly increases SVR odds while producing negligible sx. And there doesn't seem to be any lasting effects. Most of my complaints are SOC related.
Kittyface
Hi, Ev. I have some links to HR's posts saved in a file, but if you have that particular one at hand, please post it for me. I'd like to re-read it.
Regarding ALA in general, I take it but from what I've read so little actually gets into the blood that you really need to inject large does for it to boost the body's glutathione, which I believe is its principle function. I plan on upping the pill dose soon, in any case.
I agree with you about not changing things if it is working.
Myself, I have more faith in the PPC than anything else. That's probably because more positive litterature on it has been published than on the other CAMs (exceot for silibin). Plus the biochem arguments for PPC protecting liver cells are so logical.
Vitamin E supplement is a good thing to do for older people regardless if they are infected with HCV, so it can't hurt (unless you have a coogulation problem) and probably does good.
Personally, I believe that all the antioxidants help to limit the damage caused to liver cells by the virus, which has been proved to be due to oxidative processees caused by free radical formation in the liver. The only limiting factor to the use of antioxidants as a treatment, as I see it, is their possible side effects. So far I haven't seen any with what I'm taking, and it sounds like Joe hasn't had any either.
We make good guinea pigs, huh? Some researchers should be documenting all this. But heck, there's no money in it [cynical grin].
Mike
Regarding ALA in general, I take it but from what I've read so little actually gets into the blood that you really need to inject large does for it to boost the body's glutathione, which I believe is its principle function. I plan on upping the pill dose soon, in any case.
I agree with you about not changing things if it is working.
Myself, I have more faith in the PPC than anything else. That's probably because more positive litterature on it has been published than on the other CAMs (exceot for silibin). Plus the biochem arguments for PPC protecting liver cells are so logical.
Vitamin E supplement is a good thing to do for older people regardless if they are infected with HCV, so it can't hurt (unless you have a coogulation problem) and probably does good.
Personally, I believe that all the antioxidants help to limit the damage caused to liver cells by the virus, which has been proved to be due to oxidative processees caused by free radical formation in the liver. The only limiting factor to the use of antioxidants as a treatment, as I see it, is their possible side effects. So far I haven't seen any with what I'm taking, and it sounds like Joe hasn't had any either.
We make good guinea pigs, huh? Some researchers should be documenting all this. But heck, there's no money in it [cynical grin].
Mike
the one I'm most intersted in right now is dashan, and the formula fuzheng huayu, I have a thread on it in here.
I agree that the things HR suggested are helpful, there are may ways to soften up and get fibrotic reversal, and even if you get pockets of softening it will help.
The latest fibroscan's show folks on these regimes are getting measurable improvements in their tissue stuctures and livers become much closer to normal where blood flow brings these helpful compounds.
Mhudnail is on quite a cocktail of stuff, HR's suggestions as well as Zhang's herbs, LDN and more.
His fibroscans have proven reversals, reversals seldom seen I might add, and done by one of the world's formost authorites to boot.... but the drop in his VL after adding the LDN was most impressive.
I asked to see and review his labs before believing it, and he was gracious enough to accomodate that.
You may want to PM him and pick his brains, it seems he has made some opponents in here, but he is very well versed and in a medical field.
As far as the PPC goes, I have a purer source than LEF for you, if you are interested.
Yes, it's too bad about the Alinia, I think Romark may have rushed things because they saw so much potential with the geno 4's they wanted on board (cha-ching), and we all hoped they's be right and it would be a final nail in the hcv coffins....unfortunately geno 4 is like a mild cold, and geno 1 is like the the worst kick-a.s.s. version of the same....it's almost criminal to even call them the same thing considering their adaptbilities and responses to therapies are so far removed from each other.
I agree that the things HR suggested are helpful, there are may ways to soften up and get fibrotic reversal, and even if you get pockets of softening it will help.
The latest fibroscan's show folks on these regimes are getting measurable improvements in their tissue stuctures and livers become much closer to normal where blood flow brings these helpful compounds.
Mhudnail is on quite a cocktail of stuff, HR's suggestions as well as Zhang's herbs, LDN and more.
His fibroscans have proven reversals, reversals seldom seen I might add, and done by one of the world's formost authorites to boot.... but the drop in his VL after adding the LDN was most impressive.
I asked to see and review his labs before believing it, and he was gracious enough to accomodate that.
You may want to PM him and pick his brains, it seems he has made some opponents in here, but he is very well versed and in a medical field.
As far as the PPC goes, I have a purer source than LEF for you, if you are interested.
Yes, it's too bad about the Alinia, I think Romark may have rushed things because they saw so much potential with the geno 4's they wanted on board (cha-ching), and we all hoped they's be right and it would be a final nail in the hcv coffins....unfortunately geno 4 is like a mild cold, and geno 1 is like the the worst kick-a.s.s. version of the same....it's almost criminal to even call them the same thing considering their adaptbilities and responses to therapies are so far removed from each other.
Did you read HR's latest comments on alpha lipoic acid? He said the R form of it is more effective. Check it out. He goes in to effective doses also. You don't want to miss anything HR writes.
We tried lots of stuff with Joe but doing what HR said to do is the only thing that made a measurable and obvious difference. Joe is taking LDN also. Our Dr. did not have any qualms about prescribing it. He didn't know if it would help but he didn't see it as potentially harmful either. I am inclined to think it has helped in his recovery from a long,difficult and unsuccessful TX. He has only had one lab since his last TX failure and his viral load was in the 6,000,000 range which I didn't see as bad for a geno 1 with cirrhosis. Joe has had some much higher viral loads than that before but not since using HR's supplements. Joe's recovery time and improvements may be all due to HR's supplements instead of the LDN and I have no way of knowing for sure but I don't feel inclined to change anything.The boat is afloat so we aren't going to rock it. He has been on LDN since early September.
Ev
We tried lots of stuff with Joe but doing what HR said to do is the only thing that made a measurable and obvious difference. Joe is taking LDN also. Our Dr. did not have any qualms about prescribing it. He didn't know if it would help but he didn't see it as potentially harmful either. I am inclined to think it has helped in his recovery from a long,difficult and unsuccessful TX. He has only had one lab since his last TX failure and his viral load was in the 6,000,000 range which I didn't see as bad for a geno 1 with cirrhosis. Joe has had some much higher viral loads than that before but not since using HR's supplements. Joe's recovery time and improvements may be all due to HR's supplements instead of the LDN and I have no way of knowing for sure but I don't feel inclined to change anything.The boat is afloat so we aren't going to rock it. He has been on LDN since early September.
Ev
Hi, Merry! Nice to hear from you. Yes, I am eating my chicken soup, but so far it's just giving me a stomach ache and making me sweat. I will admit, however, that I don't know how to make it like momma did.
Your analysis of the research sounds right. It really is too bad that they don't all do timing studies on lead-ins, since the whole game is viral load dynamics. I can't figure out why Romark isn't following through with this, as they started out on the right track, comparing 4-week to 12-week lead-ins and also making a time-release capsule. They're obviously forced to make some serious research decisions, since it's a relatively small lab, and I guess they went for the non-responder niche with the geno 1s (which is certainly too bad as far as I'm concerned), but how they could have lost sight of the lead-in advantage is a big question.
As you say, a lot of this research is off base on fundamental theory and gets side-tracked, then they wake up when it's too late (too costly) to go back and do it right.
I haven't been following Muhudnail's threads, but I will look at them now. I did check out LDN therapy a while back, and there just wasn't enough info on its effectiveness with HCV, nor its side effects, for me to have much immediate interest in it. Sometimes I do get the urge to experiment on myself with a combination cocktail of Alinia, LDN, PPC, and a couple of other things. My latest bloods (done last week in NYC) came back with ALT and AST down to within normal range and my platelets back up above the lower limit of normal, both for the first time in four years! The only thing I can attribute this startling surprise to is the PPC-ALA-Vitamin E-Siliphos I have been taking for the past six months, unless it's my immune system that has somehow gotten reactivated, which I seriously doubt.
I'm obviously gonna keep doing the CAMs, and I'll just wait for the second biopsy sometime this year or next. By then one or another of the PIs should be approved, in case my fibrosis stage has moved up and I'm forced to treat.
Gee, I wonder if there's anything I can put into this chicken soup that would make it less obnoxious. Grated cheese? Lemon? Matzoh balls?
Mike
Your analysis of the research sounds right. It really is too bad that they don't all do timing studies on lead-ins, since the whole game is viral load dynamics. I can't figure out why Romark isn't following through with this, as they started out on the right track, comparing 4-week to 12-week lead-ins and also making a time-release capsule. They're obviously forced to make some serious research decisions, since it's a relatively small lab, and I guess they went for the non-responder niche with the geno 1s (which is certainly too bad as far as I'm concerned), but how they could have lost sight of the lead-in advantage is a big question.
As you say, a lot of this research is off base on fundamental theory and gets side-tracked, then they wake up when it's too late (too costly) to go back and do it right.
I haven't been following Muhudnail's threads, but I will look at them now. I did check out LDN therapy a while back, and there just wasn't enough info on its effectiveness with HCV, nor its side effects, for me to have much immediate interest in it. Sometimes I do get the urge to experiment on myself with a combination cocktail of Alinia, LDN, PPC, and a couple of other things. My latest bloods (done last week in NYC) came back with ALT and AST down to within normal range and my platelets back up above the lower limit of normal, both for the first time in four years! The only thing I can attribute this startling surprise to is the PPC-ALA-Vitamin E-Siliphos I have been taking for the past six months, unless it's my immune system that has somehow gotten reactivated, which I seriously doubt.
I'm obviously gonna keep doing the CAMs, and I'll just wait for the second biopsy sometime this year or next. By then one or another of the PIs should be approved, in case my fibrosis stage has moved up and I'm forced to treat.
Gee, I wonder if there's anything I can put into this chicken soup that would make it less obnoxious. Grated cheese? Lemon? Matzoh balls?
Mike
we used to get told to "eat our chicken soup"..turns out, it was the onions and garlic in the mix that had the anti-viral properties that were helping folks recover from flus etc.
I think Alinia may end up in that category...yes it's anti-parisitical, yes, it's somewhat antiviral, but bottom line is stats were not much better except in the geno 4 category, which makes sense since they have the weakest strain of the virus anyway.
Going forward it might prove helpful for that genotype certainly, but Keefe's numbers weren't as stellar as the Eyptian studies, and you are right, the lead-in's wren't done.
But then, to give the devil his due, no one really focused on lead-in's save boceprevir...in future I think more studies will, now that they've figured out the benefits, but it's hard to go back and repeat multimillion dollar studies after the fact.
It's hard enough to get research for new drugs let alone back the train over old ones.
It's just unfortunate that no one thought to raise the Riba to therapeutic levels before introducing the 1-2 punch sooner.
I don't think this was intentional...like a lot of things...there was probably an oh-duh moment heard throughout the research world on that one.
Have a little chicken soup Mike....and say...have you looked into LDN therapy?
Muhudnail's VL labs were impressive, he's down to almost nothing on VL since getting on it. This at least would be an arm in the dike, so to speak,
mb
I think Alinia may end up in that category...yes it's anti-parisitical, yes, it's somewhat antiviral, but bottom line is stats were not much better except in the geno 4 category, which makes sense since they have the weakest strain of the virus anyway.
Going forward it might prove helpful for that genotype certainly, but Keefe's numbers weren't as stellar as the Eyptian studies, and you are right, the lead-in's wren't done.
But then, to give the devil his due, no one really focused on lead-in's save boceprevir...in future I think more studies will, now that they've figured out the benefits, but it's hard to go back and repeat multimillion dollar studies after the fact.
It's hard enough to get research for new drugs let alone back the train over old ones.
It's just unfortunate that no one thought to raise the Riba to therapeutic levels before introducing the 1-2 punch sooner.
I don't think this was intentional...like a lot of things...there was probably an oh-duh moment heard throughout the research world on that one.
Have a little chicken soup Mike....and say...have you looked into LDN therapy?
Muhudnail's VL labs were impressive, he's down to almost nothing on VL since getting on it. This at least would be an arm in the dike, so to speak,
mb
Thanks for the URLs. I'll check them out tomorrow. Yes, I think you're right, there's probably enough data in by now to believe that NTZ does help. But there are some big questions still unanswered, like lead-in or not and lead-in times, dosage (time-release?), and sides. Frankly, I don't understand why Romark is putting so much effort into a non-resonders trial when nothing definitive is out yet about their naive geno 1s trial. Something's fishy about their trials sequencing. I'm a stickler for logic, and it makes me nervous.
M.
M.
You have just made my night. Still laughing.. Thank you from those of us grasping at straws!
interesting.. robo-mails or human-mails? If the former possibly a failure to award the much coveted BGC? it's getting wierder around here..
anyway, with respect to Romark best place to look for updates is the EASL-10 site iself (scientific program/search)
checking for NTZ in abstract text gives three presentations:
http://www.kenes.com/easl2010/Posters/Abstract130.htm
http://www.kenes.com/easl2010/Posters/Abstract1.htm
http://www.kenes.com/easl2010/Orals/296.htm
the 1st (high dose) report yielded decent results: 56% SVR in a group with 21% blacks and mean BMI 28. Though the results among non-responders weren't that great, the mechanism is completely independent of DAAs - so it's likely a helpful adjunct to non-responders treating with a PI. I'm seeing my heppo in a couple of weeks and will check whether he's on board with following that dosing regimen for my next try.
anyway, with respect to Romark best place to look for updates is the EASL-10 site iself (scientific program/search)
checking for NTZ in abstract text gives three presentations:
http://www.kenes.com/easl2010/Posters/Abstract130.htm
http://www.kenes.com/easl2010/Posters/Abstract1.htm
http://www.kenes.com/easl2010/Orals/296.htm
the 1st (high dose) report yielded decent results: 56% SVR in a group with 21% blacks and mean BMI 28. Though the results among non-responders weren't that great, the mechanism is completely independent of DAAs - so it's likely a helpful adjunct to non-responders treating with a PI. I'm seeing my heppo in a couple of weeks and will check whether he's on board with following that dosing regimen for my next try.
Medhelp sent me an email telling me there were answers to my post (as if I didn't know) and that I should reply to them and thank people for posting (as if I hadn't done so). As a matter of fact I never received emails from Medhelp about the postings, but as I always monitor my threads I caught them.
I don't know what gives with Medhelp, but I've learned that it isn't wise to cross them, so let me take this opportunity to thank everyone who posted to this thread. I love you all. (Aw, gee...) And if the Medhelp crew are eavesdropping, I love you guys and gals, too. So, there!
Mike
I don't know what gives with Medhelp, but I've learned that it isn't wise to cross them, so let me take this opportunity to thank everyone who posted to this thread. I love you all. (Aw, gee...) And if the Medhelp crew are eavesdropping, I love you guys and gals, too. So, there!
Mike
Have an Answer?
You are reading content posted in the Hepatitis C Community
Learn about this treatable virus.
Getting tested for this viral infection.
3 key steps to getting on treatment.
4 steps to getting on therapy.
What you need to know about Hep C drugs.
How the drugs might affect you.
These tips may up your chances of a cure.
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.
