Aa
viral breakthrough
I have been doing some researching on this topic, As I understand it is that the virus changes DNA, and is resistant to interferons. I had a question asked that got me thinking,this virus is so elusive could it change it's DNA in a way that is undetectable by current PCR testing in some cases.Cringe at the thought, but it was A question that really got me to thinking.
howdeee....no bowling today?
have you heard from cquest? I sent her a couple emails and they came back as email no longer valid....
*dip*
have you heard from cquest? I sent her a couple emails and they came back as email no longer valid....
*dip*
Wow you have a lot of lifetime similarities with ME (my daughter too).
I know how much you've got on your plate but doesn't it seem like all things lined up perfectly for you to find out that you had HCV?
I think those of us who had NO idea - who have some strange way of finding out that we even HAVE it - we are the very blessed ones.
When I get depressed about tx I just stop and think WOW if not for the set of circumstances I could have gone on for another ten years not knowing.......and been completely out of liver cells by then and it could have been too late.
I think in the scheme of things....we are the lucky ones. I truly believe that the millions of people running around with these cooties in them that have NO idea - that will find out many years from now when it's too late.....they are the ones who have it hard.
Not us! :) :)
Debby
I know how much you've got on your plate but doesn't it seem like all things lined up perfectly for you to find out that you had HCV?
I think those of us who had NO idea - who have some strange way of finding out that we even HAVE it - we are the very blessed ones.
When I get depressed about tx I just stop and think WOW if not for the set of circumstances I could have gone on for another ten years not knowing.......and been completely out of liver cells by then and it could have been too late.
I think in the scheme of things....we are the lucky ones. I truly believe that the millions of people running around with these cooties in them that have NO idea - that will find out many years from now when it's too late.....they are the ones who have it hard.
Not us! :) :)
Debby
Sorry bout the hair! But, I hear it grows back. Let's just hope it doesn't grow back WHITE & fluffy!
Sorry to hear you have not responded well to tx. By all measures there are 2 new drugs, vx-950 and another; estimated to be out in 2009; at least by 2010. The down side is they are still looking into mixing cocktails with these drugs. VX-950 has already mentioned using interferon.
That complicates matters when alot of people that are in need of new drugs, have to also get away from the current meds. It's not as simple as adding something to become more effective. Some people can't take the interferon, or can't take the riba.
My sceptical side still sees them using one or both, and because of the way the new drugs are acting; I think they will probably still use the riba. Just one man's thoughts. Peace
That complicates matters when alot of people that are in need of new drugs, have to also get away from the current meds. It's not as simple as adding something to become more effective. Some people can't take the interferon, or can't take the riba.
My sceptical side still sees them using one or both, and because of the way the new drugs are acting; I think they will probably still use the riba. Just one man's thoughts. Peace
I understood your post. I do think that the next generation drugs, whether they be PI's Polymerase Inhibitors, or Helicase Inhibitors have major advantages over current SOC. There have been many lessons learned in the last 10 years that can be applied. For example, in the beginning, tx time. It was long for everyone. Then, they found that those who cleared early (4 weeks, mostly 2's and 3's) had the same odds of SVR if they treated only 12 weeks, etc.
Also, the next generation of drugs (at least 950 anyway) has identified the trough concentration level necessary to produce a continued decline, which is what got those 4 in TID to undetectable in 2 weeks.
For those who don't know what trough concentration levels are, that is the MINIMUM amount of drug in the liver due to dosing times, etc. I belive it is 1050 nanograms in TID, whereas the rebound groups only had about 700 nanograms. Again, that was without interferon, which will help that.
It is kind of like being the 3rd of 3 kids in a family. The oldest goes through all of the garbage-early curfews, less freedom, etc. By the time you get to the baby of the family, they're thankful for those who came before them. For example, my parents taught my older sister to drive. After that, thank God I had a driving school.
Also, the next generation of drugs (at least 950 anyway) has identified the trough concentration level necessary to produce a continued decline, which is what got those 4 in TID to undetectable in 2 weeks.
For those who don't know what trough concentration levels are, that is the MINIMUM amount of drug in the liver due to dosing times, etc. I belive it is 1050 nanograms in TID, whereas the rebound groups only had about 700 nanograms. Again, that was without interferon, which will help that.
It is kind of like being the 3rd of 3 kids in a family. The oldest goes through all of the garbage-early curfews, less freedom, etc. By the time you get to the baby of the family, they're thankful for those who came before them. For example, my parents taught my older sister to drive. After that, thank God I had a driving school.
I agree with you cougar, is just too soon to judge, and for some too long to wait for the final results, either because of liver damage or aging. it is ok for those with wiggle room.
CTON
it worries me that so many are waiting without the full knowledge of their liver damage status. Without a fibroscan+fibrotest(combo test that most accurately reflects bx results) available for most, biopsy is the best diagnostic tool still. I would be scared to wait without that knowledge, especially after reading lvdbygod and painintheside experiences.
Adverse events are so rare now that they use ultrasound guidance that it makes me wonder why drs are so reluctant.
Best to you
CTON
it worries me that so many are waiting without the full knowledge of their liver damage status. Without a fibroscan+fibrotest(combo test that most accurately reflects bx results) available for most, biopsy is the best diagnostic tool still. I would be scared to wait without that knowledge, especially after reading lvdbygod and painintheside experiences.
Adverse events are so rare now that they use ultrasound guidance that it makes me wonder why drs are so reluctant.
Best to you
They won't say, but if they file in early 2008, they would have the drug approved in less than 6 months. From there, it does take some time to get to market. I don't see how it could be any time before late 2008, and that of course, assumes everything goes according to plan. So far, the time line they have been giving from the start of the clinical trials is holding up, but the tough studies are ahead.
In order to cut down on time to market, they have stated they will be manufacturing to 1 ton scale up by 2006. They are preparing as if there will be high demand once approved. It is a large task, that is why they are starting it soon.
I guess with any drug, there is a window in between approval and time to launch, and I don't think they know what that would be right now.
In order to cut down on time to market, they have stated they will be manufacturing to 1 ton scale up by 2006. They are preparing as if there will be high demand once approved. It is a large task, that is why they are starting it soon.
I guess with any drug, there is a window in between approval and time to launch, and I don't think they know what that would be right now.
My doc isn't necessarily reluctant, if I wanted one tomorrow, he would whole-heartedly endorse it. I made the decision based on other diagnostic tests, etc., and other monitoring. The thing that most in here don't realize is, that I am NOT a good candidate at all for current treatment. Riba is not a good option for me, and interferon will exacerbate other problems, probably severely. Yes, it is good to know, and both docs agree with that.
I should add, that adverse events were not a factor in my decision.
it sounds as if you would not be able to do anything, even if you were close to stage 4, even scarier...
how do you deal with the mental part of those thoughts? is it mostly HOPE?
how do you deal with the mental part of those thoughts? is it mostly HOPE?
If I were there, then yes, I could try treatment. My other numbers as of last test were not indicative of that.
"how do you deal with the mental part of those thoughts? is it mostly HOPE?"
Those are not my thoughts. It is not good to make assumptions. This focus on me the last couple of days (where no one knows me or my situation) quite frankly, is making me uncomfortable. I don't like being a focus for attention, I never have. I usually don't post on most message boards because I like to leave ME out of things. I much prefer to pass along information.
"how do you deal with the mental part of those thoughts? is it mostly HOPE?"
Those are not my thoughts. It is not good to make assumptions. This focus on me the last couple of days (where no one knows me or my situation) quite frankly, is making me uncomfortable. I don't like being a focus for attention, I never have. I usually don't post on most message boards because I like to leave ME out of things. I much prefer to pass along information.
no focus just appreciation for all your knowledge&info-thank you v much&please continue helping.....
Thank you, I will. It is probably my own fault really, for bringing it up.
Hi there :)
I found this really neat site that has a chart that shows the "The New Drug Timelines" from research all the way through to market, but it's a jpeg file...I would like to post that here but I don't know how to post images in here...Anywhoo, it says the timeline from soup to nuts is 7-12 years...How long did it take Vertex for Phase I do you know?
*diipers*
I found this really neat site that has a chart that shows the "The New Drug Timelines" from research all the way through to market, but it's a jpeg file...I would like to post that here but I don't know how to post images in here...Anywhoo, it says the timeline from soup to nuts is 7-12 years...How long did it take Vertex for Phase I do you know?
*diipers*
My doctor said we have at least 10 years before better drugs. This is as good as it gets. I also heard that Hep C does not become resistant to the interferons. Meaning you can treat once and fail and do it again.
I believe this first started to be developed in 1995 or so, so it is already 10 years in. When things get into the clinic, then assumptions can start to be made. For example, lets take HGSI with Albuferon. Assuming it works and is safe, which available data supports, we know that trials will be up to 48 weeks with 6 month follow up. Depending on when P2 started and finishes, you can start to make an estimate. There is some time in between for data analaysis, etc.
There were 2 delays that I know of when it comes to VX-950. First, there was a legal battle with Chiron, who discovered the virus. They have patents on it, and no one can research it without settling with them first. I will bite my tongue here. Hard.
I think I might have a PR saved on that somewhere, otherwise I know I have read this in non-Vertex articles.
Second, they were originally partnered with Ely Lilly with this drug. A few years ago, Lilly decided to go in a different direction. At the time, phase 1 was planned to be started in 2003. The settlement took a while, and delayed phase 1 by a year.
I also get the feeling that it doesn't matter if the FDA fast tracks or not (different than priority review). Due to the large amount of work it will take to get the drug to market as quickly as possible, they don't feel they could get it out any sooner anyway.
I will mess this up, but fast tracking has to do with how the FDA speeds up the analysis of and submission of data (someone please correct me here, I don't think I am explaining this right).
Priority review happens AFTER clinical trials, where an NDA is submitted, and a ruling is made in under 6 months (might be 5 months or less, whereas normal timeframe is around 11 months).
There were 2 delays that I know of when it comes to VX-950. First, there was a legal battle with Chiron, who discovered the virus. They have patents on it, and no one can research it without settling with them first. I will bite my tongue here. Hard.
I think I might have a PR saved on that somewhere, otherwise I know I have read this in non-Vertex articles.
Second, they were originally partnered with Ely Lilly with this drug. A few years ago, Lilly decided to go in a different direction. At the time, phase 1 was planned to be started in 2003. The settlement took a while, and delayed phase 1 by a year.
I also get the feeling that it doesn't matter if the FDA fast tracks or not (different than priority review). Due to the large amount of work it will take to get the drug to market as quickly as possible, they don't feel they could get it out any sooner anyway.
I will mess this up, but fast tracking has to do with how the FDA speeds up the analysis of and submission of data (someone please correct me here, I don't think I am explaining this right).
Priority review happens AFTER clinical trials, where an NDA is submitted, and a ruling is made in under 6 months (might be 5 months or less, whereas normal timeframe is around 11 months).
I accidentally hit post.
So, with VX-950, it looks like it will be 13-14 years soup to nuts (1995-late 2008). 1 year of that was not due anything with the drug, and I would consider to be an anomaly.
Let's take another example. BIIB (Biogen Idec) announced right after VRTX's news that they discovered the gene responsible for causing MS, and actually shut it off and REVERSED the process in vitro. BTW, I think this was important news that got overshadowed by other things, including their problems with Tysabri at the time.
I don't know when they started working on this, but we can watch and see how long it takes for this to progress. It is my opinion that this is still many, many years away, as I am not sure if it has even been tested in animals yet. But, they were able to re-generate the myelin sheathing around the nerves with the lesions. Since I follow biotech stocks, I actually did call the company and ask them about this, but they couldn't say much.
So, with VX-950, it looks like it will be 13-14 years soup to nuts (1995-late 2008). 1 year of that was not due anything with the drug, and I would consider to be an anomaly.
Let's take another example. BIIB (Biogen Idec) announced right after VRTX's news that they discovered the gene responsible for causing MS, and actually shut it off and REVERSED the process in vitro. BTW, I think this was important news that got overshadowed by other things, including their problems with Tysabri at the time.
I don't know when they started working on this, but we can watch and see how long it takes for this to progress. It is my opinion that this is still many, many years away, as I am not sure if it has even been tested in animals yet. But, they were able to re-generate the myelin sheathing around the nerves with the lesions. Since I follow biotech stocks, I actually did call the company and ask them about this, but they couldn't say much.
let's all keep our fingers crossed that 950 progresses smoothly without hitch..It seems to be the front line runner..Maybe ny 2010 we can have that puppy available to all...
My wife has always wanted a puppy. Since I am allergic, let's call it a hypoallergenic dog.....
I think you missed my point, it all looks like the new drugs(at least 2) will be available by 2010, by FDA standards. They are still adjusting tx protocol to improve svr stats and control sx with the current meds, how many years pass lauching. Svr rates for type 1's started in the 20 something % range, with alot more drop outs and people being pulled.
I believe for them to get a true handle on protocol, sx management, risk vs SVR stats; it will be heading toward 10 years. Peace.
I believe for them to get a true handle on protocol, sx management, risk vs SVR stats; it will be heading toward 10 years. Peace.
When does the VRTX timeline project vx-950 availability via prescription to the general public?
To anyone interested, Naomi Judd is getting a talk show.
http://www.post-gazette.com/pg/05325/609926.stm
http://www.post-gazette.com/pg/05325/609926.stm
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