Aa
new drugs and Geno 2 & 3
i'm asking for a friend of mine, are any of the new drugs in trial for 2 & 3's? my friend claims his doctor told him that they were only for 1's and it would be much longer to get approval for 2 & 3's. is this true? i think with VX-950 all the trials have been with 1's, will they be able to use it with 2 & 3's even if it had only been trialed with 1's when approved? does anyone have study links that include GT 2 & 3's i would like to provide him with these if there are any. the links could be from any new drug. i just want to give him some hope. thanks
you are absolutely right there, entering the field, one can choose what to research quite often, as far a disease...take Jarvik and his famly heart history...and on and on...but once you are down to brass tacks, and assuming either you have a government grant or are running pharmaceutical trials, either way the criteria, method, parameters tend to be spelled out by other than the researcher,
I think that;;s the whole point of raising funds for private research receiving as much as they do.....because some are so frustrated by the regulations they try to circumvent them.
this may speed up research but slows drug approval to a crawl, I'm not a big fan of FDA but it does seem that unless the dots are connected we could end up with things on the market that make all the e-coli outbreaks and recall scares look like a cake walk. I'm not sure we want that either.
As long as we have a corporate memory of things like thalidomide for example, there are going to be very extensive trials before things are let go....the motto being similar to that of the physicians...first, do no harm. Can't always mean no sides of course, but there have to be trade off.
It get;s pretty scary when the new chemos have 5 percent mortality rates and we can correlate that with treatment not disease advancement.
Right now, I think the system is working fairly well, since the majority of trial recipients are those not helped by SOC or uninsured and unable to get meds. In both cases the trials allow research to go forward both where the need is greatest, and the most good may be being done, albeit not without some risk. Still, this seems a netter approach than Europe for instance where things are kicked ouy there almost overnight, and then they pray things don't come back to haunt them.
some of that might have seemed neccessary to research in say WWII, when Oppenheimer held his ears, and hoped the entire planet atmosphere didn't ignite in a perpetual domino effect...but it seems a little irresponsible to apply to same tactics to new medical molecules.
Did you read the piece about the 4th largest pollutant in our rivers now being Vicodine???
So makes me wonder, well just how are the sharks and jellyfish feeling these days???
I think that;;s the whole point of raising funds for private research receiving as much as they do.....because some are so frustrated by the regulations they try to circumvent them.
this may speed up research but slows drug approval to a crawl, I'm not a big fan of FDA but it does seem that unless the dots are connected we could end up with things on the market that make all the e-coli outbreaks and recall scares look like a cake walk. I'm not sure we want that either.
As long as we have a corporate memory of things like thalidomide for example, there are going to be very extensive trials before things are let go....the motto being similar to that of the physicians...first, do no harm. Can't always mean no sides of course, but there have to be trade off.
It get;s pretty scary when the new chemos have 5 percent mortality rates and we can correlate that with treatment not disease advancement.
Right now, I think the system is working fairly well, since the majority of trial recipients are those not helped by SOC or uninsured and unable to get meds. In both cases the trials allow research to go forward both where the need is greatest, and the most good may be being done, albeit not without some risk. Still, this seems a netter approach than Europe for instance where things are kicked ouy there almost overnight, and then they pray things don't come back to haunt them.
some of that might have seemed neccessary to research in say WWII, when Oppenheimer held his ears, and hoped the entire planet atmosphere didn't ignite in a perpetual domino effect...but it seems a little irresponsible to apply to same tactics to new medical molecules.
Did you read the piece about the 4th largest pollutant in our rivers now being Vicodine???
So makes me wonder, well just how are the sharks and jellyfish feeling these days???
Just keep prayin the little test tube nerds are hard at it
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That's pretty funny. ;)
I do have to say though, my best friend (ya know, the one who came over and cleaned everyone's barf up this weekend) is in an online class with a girl who works for the company that produces alinia. The girl said that she specifically is interested in her job because her mother is a hepc non-responder. So... you have to think that at least sometimes, people do have a personal medical or family medical reason for doing this type of research. I have found in medicine that this is frequently the case, that people enter the field in certain venues due to a family member's death or illness.
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That's pretty funny. ;)
I do have to say though, my best friend (ya know, the one who came over and cleaned everyone's barf up this weekend) is in an online class with a girl who works for the company that produces alinia. The girl said that she specifically is interested in her job because her mother is a hepc non-responder. So... you have to think that at least sometimes, people do have a personal medical or family medical reason for doing this type of research. I have found in medicine that this is frequently the case, that people enter the field in certain venues due to a family member's death or illness.
I know it seems hard to be excluded, it's the pits. I think they have to balance who stands to benefit, and the money, and how to get it to pass. Limited numbers allowed since money per hospital is doled out. then you have 90 cured on typeb-c...so the 2 ers, well they can benefit most, and their troals if possiyve will endure drug passage...cause this is noy where SOC is at 90...its at 50 percent/
this will all prove the drug more than leave it floundering as to voracity.
glad to hear non=responders are getting in though.
the idea is to prove a higher success rate than with current SOC....which is why this all makes sense...unless you are being left out...anf then it really never does or can.
Just keep prayin the little test tube nerds are hard at it. A lot of how they must do the research is laid out by government FDA control regulations and not just the product of someones own discriminatoy nature.
hope that helps.
this will all prove the drug more than leave it floundering as to voracity.
glad to hear non=responders are getting in though.
the idea is to prove a higher success rate than with current SOC....which is why this all makes sense...unless you are being left out...anf then it really never does or can.
Just keep prayin the little test tube nerds are hard at it. A lot of how they must do the research is laid out by government FDA control regulations and not just the product of someones own discriminatoy nature.
hope that helps.
I am in the same trial as maryh685-Albumin Interferon versus Pegasy. I 'drew' the Pegasy tho.
To my understanding , Albumin Interferon is 'simply' the reg. interferon moleculed to Albumin for longer half life, less shots, perhaps better tolerated.
I am at Shands in my trial. Pull up Human Genome Sciences. They are quoting this to be 'out' by 2009-2010.
mary, which one did you 'draw' ? The 180mg peg/800 Riba is kicking my 125 (now) a*s!!
Discussing reducing dose's today, tho harder to get done in their 'standard' per trial.
Myown, sad but true. So few 2-3's don't make SVR I do believe we get left behind in studies. I 'think' you did the whole 24 weeks?
VERY sorry for you, if I haven't said it in other post.
LL
To my understanding , Albumin Interferon is 'simply' the reg. interferon moleculed to Albumin for longer half life, less shots, perhaps better tolerated.
I am at Shands in my trial. Pull up Human Genome Sciences. They are quoting this to be 'out' by 2009-2010.
mary, which one did you 'draw' ? The 180mg peg/800 Riba is kicking my 125 (now) a*s!!
Discussing reducing dose's today, tho harder to get done in their 'standard' per trial.
Myown, sad but true. So few 2-3's don't make SVR I do believe we get left behind in studies. I 'think' you did the whole 24 weeks?
VERY sorry for you, if I haven't said it in other post.
LL
i am type 3 and in a study right now for alnumin interferon the holder of the study is HGS
they are on line as albuinterferon also
maryh685
they are on line as albuinterferon also
maryh685
i hope so. NO one should be left out. but i would think once approved it can be dosed for anyone with HCV.
when I was up in Boston (consult), I asked the liver fellow why aren't the 2 and 3's involved in any studies and he said.. M o n e y.
If there aren't a whole lot of us I guess they're not interested. I get disgusted about that. Yeah you're lucky to be a geno 2 people say, but thats IF you clear as far as I am concerned..... and there still "should be" studies that include 2's and 3's and SO what if ..... your geno 2 "relapser" as in my case,,,not even just ..why aren't they using 2's,,,but NOW I have to concern myself with .. are they going to use geno 2 relapsers in studies cause when you think of it, if the stats are accurate,,,,there are NOT a whole lot of geno 2's who didn't make it to the other side,,,so will these studies include "a small minority within a minority?"
If there aren't a whole lot of us I guess they're not interested. I get disgusted about that. Yeah you're lucky to be a geno 2 people say, but thats IF you clear as far as I am concerned..... and there still "should be" studies that include 2's and 3's and SO what if ..... your geno 2 "relapser" as in my case,,,not even just ..why aren't they using 2's,,,but NOW I have to concern myself with .. are they going to use geno 2 relapsers in studies cause when you think of it, if the stats are accurate,,,,there are NOT a whole lot of geno 2's who didn't make it to the other side,,,so will these studies include "a small minority within a minority?"
Oops line 2 should have read "have not been tested in a single live G2 or G3 patient"
Didnt mean to imply that anyone taking vx isnt a live patient.
CS
Didnt mean to imply that anyone taking vx isnt a live patient.
CS
Drofi the study above is fine but VX-950 or any of the other new drugs for that matter have not been tested in a single live patient.
My understanding is that his will occur for vx next year,
So copy i think your friends Doc is right. No new drugs for us 2s&3s yet
CS
My understanding is that his will occur for vx next year,
So copy i think your friends Doc is right. No new drugs for us 2s&3s yet
CS
TELAPREVIR (VX-950) IS A POTENT INHIBITOR OF HCV NS3 PROTEASES DERIVED FROM
GENOTYPE NON-1 HCV-INFECTED PATIENTS
C. Lin 1, B.L. Hanzelka 1, U. Muh 1, L. Kovari 1, D.J. Bartels 1, A.M.
Tigges 1, J. Miller 1, B.G. Rao 1, A.D. Kwong 1
1 Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA
Background: Telaprevir (TVR, VX-950) is a highly selective HCV NS3•4A
protease inhibitor. Strong antiviral activity, such as a continuous,
multi-log10 decline in plasma viral RNA levels, has been observed in
genotype 1 HCV-infected subjects, who received telaprevir alone (> 4-log10
reduction) or in combination with peginterferon alfa with or without
ribavirin (> 5-log10 reduction). While genotype 1 HCV accounts for the
majority of the HCV-infected population, a substantial portion of patients
are infected with genotype non-1 HCV. In this report, we evaluated in vitro
activity of telaprevir against HCV NS3•4A proteases derived from patients
infected with HCV of genotypes 2, 3, or 4.
Methods: Plasma HCV RNA was isolated from patients infected with genotypes
2, 3, or 4 HCV. A cDNA encompassing the full-length NS3 and NS4A proteins
was amplified by nested RT-PCR, cloned and sequenced. Depending on the amino
acid polymorphisms in the HCV NS3 protease domain of individual patients,
one or more clones were selected for expression and enzyme purification of
the NS3 protease domain, which was fused to the NS4A co-factor. The activity
of telaprevir against these patient-specific NS3•4A proteases was determined
in enzyme assays.
Results: The activity of telaprevir against patient isolates of genotype 2a,
2b, 3a, or 4a HCV proteases was comparable (within 10-fold) to that against
HCV proteases of genotype 1a or 1b. Computational modeling analysis suggests
that genotype-specific signature residues, such as residues 78-80 of
genotype 2 or residue 168 of genotype 3, may not significantly affect the
binding of telaprevir to these HCV proteases. In addition, polymorphic
variations within each genotype or subtype did not seem to have dramatic
impact on the inhibition by telaprevir, which is consistent with the
observation that most of the polymorphic variations are located far away
from the active site of the HCV protease.
Conclusions: These in vitro studies demonstrate that telaprevir is a potent
inhibitor of HCV NS3•4A proteases from genotypes 2, 3, or 4. These results
support the clinical investigation of the antiviral activity of telaprevir
in patients infected with genotypes 2, 3 or 4 HCV.
GENOTYPE NON-1 HCV-INFECTED PATIENTS
C. Lin 1, B.L. Hanzelka 1, U. Muh 1, L. Kovari 1, D.J. Bartels 1, A.M.
Tigges 1, J. Miller 1, B.G. Rao 1, A.D. Kwong 1
1 Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA
Background: Telaprevir (TVR, VX-950) is a highly selective HCV NS3•4A
protease inhibitor. Strong antiviral activity, such as a continuous,
multi-log10 decline in plasma viral RNA levels, has been observed in
genotype 1 HCV-infected subjects, who received telaprevir alone (> 4-log10
reduction) or in combination with peginterferon alfa with or without
ribavirin (> 5-log10 reduction). While genotype 1 HCV accounts for the
majority of the HCV-infected population, a substantial portion of patients
are infected with genotype non-1 HCV. In this report, we evaluated in vitro
activity of telaprevir against HCV NS3•4A proteases derived from patients
infected with HCV of genotypes 2, 3, or 4.
Methods: Plasma HCV RNA was isolated from patients infected with genotypes
2, 3, or 4 HCV. A cDNA encompassing the full-length NS3 and NS4A proteins
was amplified by nested RT-PCR, cloned and sequenced. Depending on the amino
acid polymorphisms in the HCV NS3 protease domain of individual patients,
one or more clones were selected for expression and enzyme purification of
the NS3 protease domain, which was fused to the NS4A co-factor. The activity
of telaprevir against these patient-specific NS3•4A proteases was determined
in enzyme assays.
Results: The activity of telaprevir against patient isolates of genotype 2a,
2b, 3a, or 4a HCV proteases was comparable (within 10-fold) to that against
HCV proteases of genotype 1a or 1b. Computational modeling analysis suggests
that genotype-specific signature residues, such as residues 78-80 of
genotype 2 or residue 168 of genotype 3, may not significantly affect the
binding of telaprevir to these HCV proteases. In addition, polymorphic
variations within each genotype or subtype did not seem to have dramatic
impact on the inhibition by telaprevir, which is consistent with the
observation that most of the polymorphic variations are located far away
from the active site of the HCV protease.
Conclusions: These in vitro studies demonstrate that telaprevir is a potent
inhibitor of HCV NS3•4A proteases from genotypes 2, 3, or 4. These results
support the clinical investigation of the antiviral activity of telaprevir
in patients infected with genotypes 2, 3 or 4 HCV.
The trials for the new drugs generally use naive G1's. However, when these drugs get approved by the FDA, (2-3 yrs) They can be prescribed to any Genotype at doctors discretion of course. Others with far more knowledge will weigh in soon. In the mean time take a look at the previous threads on Alinia.
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