Aa
vx-950
Hi everyone, I saw a great hep Dr. yesterday, He just completed clinical trial with peg, riba, & vx-950 12 pts, all cleared. 12 week program. I am first on the list for non responder trial. he said late fall, but they have been running a little behind. So most likely I will start in january after the holidays.YEH! He has several trials going on, but in his words ,you want to wait and go right to big one! I do not want to mess around . This is my last time around. The responce of this medication is having such great results. If I do not clear on this. I will put my disease totally in the Lords hands, and what will be will be. I hope to find all as well as can be.Great hope for nonresponders. Will keep you "all" posted
that is all very interesting, the person relapsed or had a breakthrough? if they did not stop all meds at all, then it would be the latter, but if they did stop the meds and then re started the tx with the SOC, then it is a relapse. I am guessing the tx was continuous?
If SVR is achieved how would they ascertain which meds actually worked? after the vx is withdrawn, and if there was minimal undetected VL, then it is the regular tx that would have achieved the SVR. How sensitive is the PCR, I wonder?
If they don't SVR, they can say it was the lack of VX? was the intention merely to achieve RVR and then let current tx do its normal job?
it is commendable to help these folks to achieve SVR and not just use them for preliminary data.
If SVR is achieved how would they ascertain which meds actually worked? after the vx is withdrawn, and if there was minimal undetected VL, then it is the regular tx that would have achieved the SVR. How sensitive is the PCR, I wonder?
If they don't SVR, they can say it was the lack of VX? was the intention merely to achieve RVR and then let current tx do its normal job?
it is commendable to help these folks to achieve SVR and not just use them for preliminary data.
It might be easier if I attempt to answer these one at a time, the vagaries of internet communication sometimes get in the way.
1. I guess it would be considered a breakthrough. But, it did not occur while on 950. The sensitivity to the test is to <10, so obviously, there was still virus per mililiter less than that in the blood. The way that happened implies he needed 950 longer, as just IFN and riba couldn't cut it.
1a. yes, tx is continuous.
2. Since SOC has such a large database, it is fairly easy to see if something is making a difference, but this is also why there are comparitor arms. Here is one way to compare.
In the first phase 1, it was either monotherapy, or placebo. No SOC. They got an average drop of 4.4 logs vs. nothing for placebo in 2 weeks.
The next trial added IFN ONLY and it was 5.5 logs. IFN was expected to add 1 or more logs based on its prior data, and it did.
This effect was also seen with NM 283 (and others, like Schering Plough).
3. SVR was not a goal for that trial, so it won't count anyway. The main purpose was to explore the combo for 28 days and see what happened.
4. PCR is to <10. I have mentioned that with 283, they were using <600. IMHO, I wish they would all use <2. Not sure if that is practical.
As you well know, that little residual virus adds up per milileter, which is why tx goes on much past the undetect. status.
5. The reason they couldn't treat longer at that time was they only had animal tox data for 28 days. Now they have it for 3 months, so this trial starts. 6 month data will be available soon, and they can do the next part. So, yes, I guess it is fair to say they wanted to see the response, and in fact, RVR.
6. The part about continuing on SOC is one I asked quite a while back. As you can tell from my other posts, I strongly feel that if you are going to get someone that close, then finish the job. IIRC, patients were given the option in the last 2 trials to roll over to SOC. I am sure many did.
I just hope their modeling is correct in indicating 3 months should be long enough. I have read reports that Schering Plough used the same modelling to estimate how long they would need to treat. I would imagine they all have to do that.
And, do we REALLY know how long it is necessary to treat after an undetectable reading? If 48 weeks gets one SVR after being undetectable by wk 12, then would 47 have done the same thing?
I am sure that has been discussed here many times also. There is that old rule of thumb, 3x as long as it takes to go undetect. That was being thrown around for a while, but I don't hear it lately.
Another fascinating piece to the puzzle is how HCV disables the immune response, and if you target the NS 3/4 protease, immune response is restored. I just read a blurb about that today from a scientific journal on a message board. It is highly technical, and a little over my head, but I can find it and cut and paste if anyone wants it.
1. I guess it would be considered a breakthrough. But, it did not occur while on 950. The sensitivity to the test is to <10, so obviously, there was still virus per mililiter less than that in the blood. The way that happened implies he needed 950 longer, as just IFN and riba couldn't cut it.
1a. yes, tx is continuous.
2. Since SOC has such a large database, it is fairly easy to see if something is making a difference, but this is also why there are comparitor arms. Here is one way to compare.
In the first phase 1, it was either monotherapy, or placebo. No SOC. They got an average drop of 4.4 logs vs. nothing for placebo in 2 weeks.
The next trial added IFN ONLY and it was 5.5 logs. IFN was expected to add 1 or more logs based on its prior data, and it did.
This effect was also seen with NM 283 (and others, like Schering Plough).
3. SVR was not a goal for that trial, so it won't count anyway. The main purpose was to explore the combo for 28 days and see what happened.
4. PCR is to <10. I have mentioned that with 283, they were using <600. IMHO, I wish they would all use <2. Not sure if that is practical.
As you well know, that little residual virus adds up per milileter, which is why tx goes on much past the undetect. status.
5. The reason they couldn't treat longer at that time was they only had animal tox data for 28 days. Now they have it for 3 months, so this trial starts. 6 month data will be available soon, and they can do the next part. So, yes, I guess it is fair to say they wanted to see the response, and in fact, RVR.
6. The part about continuing on SOC is one I asked quite a while back. As you can tell from my other posts, I strongly feel that if you are going to get someone that close, then finish the job. IIRC, patients were given the option in the last 2 trials to roll over to SOC. I am sure many did.
I just hope their modeling is correct in indicating 3 months should be long enough. I have read reports that Schering Plough used the same modelling to estimate how long they would need to treat. I would imagine they all have to do that.
And, do we REALLY know how long it is necessary to treat after an undetectable reading? If 48 weeks gets one SVR after being undetectable by wk 12, then would 47 have done the same thing?
I am sure that has been discussed here many times also. There is that old rule of thumb, 3x as long as it takes to go undetect. That was being thrown around for a while, but I don't hear it lately.
Another fascinating piece to the puzzle is how HCV disables the immune response, and if you target the NS 3/4 protease, immune response is restored. I just read a blurb about that today from a scientific journal on a message board. It is highly technical, and a little over my head, but I can find it and cut and paste if anyone wants it.
They are still on IFN and riba.
No more 950.
In fact, 1 of those 12 relapsed AFTER discontinuing 950. He had just gone to <10 by 28 days, and apparently, might be one who doesn't respond well to IFN. He also had the highest starting viral load.
If these people started dosing in Dec, I would imagine that means they will be on SOC until this December, a total of 1 month on the triple combo and the next 11 months on SOC only.
At AASLD, there might be more detail from that study, as that always goes on and takes a lot of time to do, but the outcome of that won't be addressed, as it is too soon.
Also, the trials that just started will not be a part of AASLD. I believe those abstracts are already submitted, but embargo rules prohibit releasing that info.
No more 950.
In fact, 1 of those 12 relapsed AFTER discontinuing 950. He had just gone to <10 by 28 days, and apparently, might be one who doesn't respond well to IFN. He also had the highest starting viral load.
If these people started dosing in Dec, I would imagine that means they will be on SOC until this December, a total of 1 month on the triple combo and the next 11 months on SOC only.
At AASLD, there might be more detail from that study, as that always goes on and takes a lot of time to do, but the outcome of that won't be addressed, as it is too soon.
Also, the trials that just started will not be a part of AASLD. I believe those abstracts are already submitted, but embargo rules prohibit releasing that info.
ty for that clarification
those 12 mentioned are not getting vx950 anymore? maybe I misread your post. what are they on? or do we know?
those 12 mentioned are not getting vx950 anymore? maybe I misread your post. what are they on? or do we know?
It wasn't in response to suzie, and probably poorly phrased, but I hear a lot of that stuff, so it sometimes sounds like it when it isn't.
It was related to what upbeat said here:
"Don't you think those in the know have the updated info from the 12 people and the people from the earlier trial? J and J had to be given some info we are not pevey to. You don't just give 500 million for the rights of over seas sales unless your certain."
I just like to be very careful about what may end up turning into a rumor. Fact is, the study is still ongoing, so there isn't much more to know. I just think we all must be careful how and what we say at times, as this is the internet. And, there is already a perception (many times false) that everything is done on an insider basis.
I just wanted to make sure I dispelled that notion.
J&J has undoubtedly seen all of the released data, but they also I am sure have had scientists review chemical structures. I know a med chemist who has HCV as his next project (might be working on it, he has been vague), and he runs circles around what the average person knows. IMHO, the chemistry AND data are important, and I am sure it was more than just data that drove that deal. That I have learned from him.
As a little aside, big pharma does not have much of a pipeline, except for a few. That is why they keep paying little bios big bucks. J&J needed that deal too.
And, maybe I should apologize, but I read too often about ulterior motives when they aren't there. Sometimes a cigar is just a cigar?
It is the company itself who told me they were still being treated, for 1 year.
It is understandable. You get these people down to undetect. in 4 weeks, and even though no more 950 is being dosed for them, there is an obligation IMHO to try to cure them. I am not sure that data will be meaningful to their cause, but hopefully that will be 12 less infected people.
It was related to what upbeat said here:
"Don't you think those in the know have the updated info from the 12 people and the people from the earlier trial? J and J had to be given some info we are not pevey to. You don't just give 500 million for the rights of over seas sales unless your certain."
I just like to be very careful about what may end up turning into a rumor. Fact is, the study is still ongoing, so there isn't much more to know. I just think we all must be careful how and what we say at times, as this is the internet. And, there is already a perception (many times false) that everything is done on an insider basis.
I just wanted to make sure I dispelled that notion.
J&J has undoubtedly seen all of the released data, but they also I am sure have had scientists review chemical structures. I know a med chemist who has HCV as his next project (might be working on it, he has been vague), and he runs circles around what the average person knows. IMHO, the chemistry AND data are important, and I am sure it was more than just data that drove that deal. That I have learned from him.
As a little aside, big pharma does not have much of a pipeline, except for a few. That is why they keep paying little bios big bucks. J&J needed that deal too.
And, maybe I should apologize, but I read too often about ulterior motives when they aren't there. Sometimes a cigar is just a cigar?
It is the company itself who told me they were still being treated, for 1 year.
It is understandable. You get these people down to undetect. in 4 weeks, and even though no more 950 is being dosed for them, there is an obligation IMHO to try to cure them. I am not sure that data will be meaningful to their cause, but hopefully that will be 12 less infected people.
"3. The 12 who cleared are still being treated. There is no conspiracy as to what happened to them. They will be tx'd for up to a year."
why the defensiveness? What in the world brought the conspiracy issue?
as you can see, suzieq believes they are done. see post above.
thank you for clarifying the other issues.
why the defensiveness? What in the world brought the conspiracy issue?
as you can see, suzieq believes they are done. see post above.
thank you for clarifying the other issues.
I am in the central texas area,Alamo medical research center in San Antonio, THis DR. cleared all twelve people.I believe 5 0r more log drop 48 hrs, undetectable 2 weeks treatment was vx & peg & riba, 12 week treatment. Done, THis very well may be the magic Bullet we have been waiting for. Check out their web site, They post results. THis center has many different trials going on. I am going for the big gun. After 44 weeks of peg/riba I will try one more time with this drug, After that I clear this disease or turn it totally over to the Lord. I would rather have a shorter life with good guality, than being sick all the time, and continue to fill my body with all these different drugs. I have great hope for the vx-950 combo treatment.My DR. is great.DR. Eric Lawitz. Alamo medical research center. I am #1 on the nonresponder list.I can do 12 more weeks. Glad they are waiting till after the holidays.Hope this helpedI was in the same shape as strator just a little ahead if hom, didn't have to work.
If Dr. J is at Cornell MC in NYC, I saw him a couple of months ago. Yes, I paid the $600, as my insurance at the time was for in-network coverage only, and as we all know, the best docs are not in any network. So I went in angry, with a bit of a chip, and was very surprised to find him concerned, helpful, open, easy to talk with, thorough, and not in any hurry to get rid of me. I spent an hour with his PA, then 45 minutes with him. Unfortunately, he did not have any particularly good news for me, but then another thing we all know by now is that there is no magic pill.
If it is the same doc, I made an appointment in December to see him in March, his earliest available time, and then he rescheduled twice, so I finally saw him in late April.
Best wishes to you, and good luck with whatever you decide.
dA
If it is the same doc, I made an appointment in December to see him in March, his earliest available time, and then he rescheduled twice, so I finally saw him in late April.
Best wishes to you, and good luck with whatever you decide.
dA
Where are you located in case there are others in your vacinity that would like to try and get into the trials?
Wasn't sure if your doctor recommended maintance or not or if you're on it. I did ask my doctor (I'm also a stage 3) what would be my next step should I fail treatment. His answer was to wait for newer drugs. Another doctor said something similar and when I said "stage 3", he said "that's not so bad. I guess it's all relative. Whatever you decide, I wish you the best.
-- Jim
-- Jim
Yep, I too am stage three, so I can understand the urgency to keep the ole liver healthy. I originally went to the doc in Seattle to start maintenance, just to keep my original organs, so I agree, some of us don't have any time to waste. The doc in Seattle said that liver years are kind of like dog years, if I don't drink alcohol, live a clean life, laugh a lot, etc. it can be a good guess that liver stage changes every 5 to 7 years. So, if the VX doesn't pan out, well, there is always maintenance for me.
Doc wasn't really thrilled with my only choice being 72 weeks of half dose of peg, he commented on the quality of life during those 72 weeks, but I told him of my great desire to keep my own organs inside me, so, I wait for about 18 more months, check into a VX trial, IF THIS ONE WORKS, or I just go on maintenance every three years. Perhaps I am really brain dead, but I kind of gave up looking for SVR last time I tried to tx and the virus mutated after just 24 weeks. So, I cross my fingers for your success and sit on my thumbs for my own chance!! Take it easy.
Willows
Doc wasn't really thrilled with my only choice being 72 weeks of half dose of peg, he commented on the quality of life during those 72 weeks, but I told him of my great desire to keep my own organs inside me, so, I wait for about 18 more months, check into a VX trial, IF THIS ONE WORKS, or I just go on maintenance every three years. Perhaps I am really brain dead, but I kind of gave up looking for SVR last time I tried to tx and the virus mutated after just 24 weeks. So, I cross my fingers for your success and sit on my thumbs for my own chance!! Take it easy.
Willows
Which laser did you have? There's one called Pulsed Dye Laser (PDL) and a newer approach called Intense Pulsed Light (IPL), which technically isn't a laser.
Very interested in when you did it, what you used, how many sessions, cost, how happy you were, did it affect beard growth, etc. Thanks.
-- Jim
Very interested in when you did it, what you used, how many sessions, cost, how happy you were, did it affect beard growth, etc. Thanks.
-- Jim
NY: Why if someone told you you could win the lotto with a 50/50 chance wouldn't you be like WOW I WON THE LOTTO! ;) I look at it the exact same way.
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If someone told me I had a 50/50 chance of winning the lottery but it might put me on the couch for a year of my life, significantlyu affect both my income and friendships, deprive my brain of blood for a year, and *maybe* leave me with irrepareable side effects for life -- not sure I'd buy that ticket.
-- Jim
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If someone told me I had a 50/50 chance of winning the lottery but it might put me on the couch for a year of my life, significantlyu affect both my income and friendships, deprive my brain of blood for a year, and *maybe* leave me with irrepareable side effects for life -- not sure I'd buy that ticket.
-- Jim
I feel I need to jump in here to clear up some things about VX-950.
1. They are not going for approval as a monotherapy. Fastest path to market is with IFN +/- riba. I say that about riba, because they don't want riba in there, but if it must be to get quicker approval, they will.
It is possible it would work as a mono, it got better results than combo did much more quickly. BUT, the A156T strain (weakly resistant strain) is sensitive to IFN. Therefore, IFN is logical.
It was already tested in the first phase 1B as a mono. That is where people get data from, NOT the company.
2. Obviously VRTX has reasons for wanting this on the market ASAP. That isn't evil. But, the FDA does not care about their balance sheet, nor should they. It is irrelevant.
Data has not been put out to hype prices either. These are done in labs and Universities in a controlled fashion.
3. The 12 who cleared are still being treated. There is no conspiracy as to what happened to them. They will be tx'd for up to a year.
4. No one has SVR data, not VRTX, not IDIX (NM 283).
5. Standard of care gets about half undetectable in 12 weeks. In a small study, 950 got them all <10 in 4 weeks. Some much sooner.
6. VX-950 would be dosed 3x per day, unless farther down the road it is boosted by Ritonavir, like the HIV drugs are.
Nothing will be settled until proof arrives. SVR data (3 month) is due in the first qtr from the 20 pts on 950 and SOC for 12 weeks. 6 month data obviously 3 months later.
VRTX needed 6 month animal studies for the non-responder group as they plan to treat them longer. Those aren't scheduled to be done until Sept. at the earliest I think.
But, the did treat non-resp. in the first trial, and they responded just the same.
IMHO, the best chance for an all-oral tx is for something with 950, but that is too far away. Also, I have read that sides really accumulate after 6 months. Hopefully that can be avoided.
1. They are not going for approval as a monotherapy. Fastest path to market is with IFN +/- riba. I say that about riba, because they don't want riba in there, but if it must be to get quicker approval, they will.
It is possible it would work as a mono, it got better results than combo did much more quickly. BUT, the A156T strain (weakly resistant strain) is sensitive to IFN. Therefore, IFN is logical.
It was already tested in the first phase 1B as a mono. That is where people get data from, NOT the company.
2. Obviously VRTX has reasons for wanting this on the market ASAP. That isn't evil. But, the FDA does not care about their balance sheet, nor should they. It is irrelevant.
Data has not been put out to hype prices either. These are done in labs and Universities in a controlled fashion.
3. The 12 who cleared are still being treated. There is no conspiracy as to what happened to them. They will be tx'd for up to a year.
4. No one has SVR data, not VRTX, not IDIX (NM 283).
5. Standard of care gets about half undetectable in 12 weeks. In a small study, 950 got them all <10 in 4 weeks. Some much sooner.
6. VX-950 would be dosed 3x per day, unless farther down the road it is boosted by Ritonavir, like the HIV drugs are.
Nothing will be settled until proof arrives. SVR data (3 month) is due in the first qtr from the 20 pts on 950 and SOC for 12 weeks. 6 month data obviously 3 months later.
VRTX needed 6 month animal studies for the non-responder group as they plan to treat them longer. Those aren't scheduled to be done until Sept. at the earliest I think.
But, the did treat non-resp. in the first trial, and they responded just the same.
IMHO, the best chance for an all-oral tx is for something with 950, but that is too far away. Also, I have read that sides really accumulate after 6 months. Hopefully that can be avoided.
I TRULY BELIEVE THAT A 2 YEAR WAIT WILL HAVE VERY MINIMUM EFFECT ON STAGE 2. WHAT IS THE DIF BETWEEN 40 AND 42? ASIDE FROM THAT THERE ARE NEW DRUGS THAT MAY REPLACE RIBA AND NOT EFFECT HGB AND ADD ON DRUGS TO PEG/RIBA THAT ARE IN TRIALS.
I REALLY FEEL ,HOWEVER UNSCIENTIFIC, THAT VX 950 WILL EVENTUALLY BE A MONO OR REPLACE THE RIBA.
PS JIM, I HAD THAT LASER TX. AND IT WORKED GREAT. DID HURT A LITTLE.
BOBBY
I REALLY FEEL ,HOWEVER UNSCIENTIFIC, THAT VX 950 WILL EVENTUALLY BE A MONO OR REPLACE THE RIBA.
PS JIM, I HAD THAT LASER TX. AND IT WORKED GREAT. DID HURT A LITTLE.
BOBBY
sAID: And yes, it does mean we may go down a stage or two,
(Sorry I don't know how i posted before) a lot of us dont HAVE another stage or two to go. Do you seriously understand how much of a difference there is between say a 1 and a 3? A stage 2 and a stage 4?
Once I SAW pictures of the huge difference in stage development and understood it all there is NO way I could chance my liver getting any worse than it already is (Stage 3). Since nobody understands the progression of how fast our liver damage can (or also can not) go...it's way too risky to me so wait for something that might not ever pan out while as a Geno 1 has a 50/50 chance that is GREAT ODDS!
Why if someone told you you could win the lotto with a 50/50 chance wouldn't you be like WOW I WON THE LOTTO! ;) I look at it the exact same way.
I mean log drops is FANTASTIC and the HOPE of a monotherapy is phenomenal...but the reality of kicking the mushrooms out of the disease TODAY is all that matters to me. I can't afford to risk it on something that might not ever work out.
And I've suffered badly at the hands of IFN with my autoimmune disease now...but wsa it worth it? If I achieve SVR yes. If not...heck all I lost was my entire metabolism...big deal... :)
(Sorry I don't know how i posted before) a lot of us dont HAVE another stage or two to go. Do you seriously understand how much of a difference there is between say a 1 and a 3? A stage 2 and a stage 4?
Once I SAW pictures of the huge difference in stage development and understood it all there is NO way I could chance my liver getting any worse than it already is (Stage 3). Since nobody understands the progression of how fast our liver damage can (or also can not) go...it's way too risky to me so wait for something that might not ever pan out while as a Geno 1 has a 50/50 chance that is GREAT ODDS!
Why if someone told you you could win the lotto with a 50/50 chance wouldn't you be like WOW I WON THE LOTTO! ;) I look at it the exact same way.
I mean log drops is FANTASTIC and the HOPE of a monotherapy is phenomenal...but the reality of kicking the mushrooms out of the disease TODAY is all that matters to me. I can't afford to risk it on something that might not ever work out.
And I've suffered badly at the hands of IFN with my autoimmune disease now...but wsa it worth it? If I achieve SVR yes. If not...heck all I lost was my entire metabolism...big deal... :)
Vetrex is the company that makes vx-950. The name now given to vx-950 is telaprevir This will be the name the drug will be known as after FDA approval
Ron
Ron
Is VX950 the same as vertex? Sorry , lots of years of hepc strangling my brain before I even got to the treatment circus. Willow, you're right, I'm confused as hell but have ears wide open.
I agree with you in that the length of treatment could have a major efect on long term sides. Our bodies are only so strong and the severe onslaught by these drugs has got to be taking their toll. Even if Vertex simply shortens the treatment I believe it would be a great bonus! I'm still in limbo about my SVR so am watching all these convos with great interest!
GO.......perhaps having faith that you'll be taken in the direction he wants you to go in is all we can do. Find peace in the faith that he knows what he's doing!
GO.......perhaps having faith that you'll be taken in the direction he wants you to go in is all we can do. Find peace in the faith that he knows what he's doing!
About the job. Before I worked for myself, I used to walk out of jobs like there was no tomorrow, but I was young, single, healthy and carefree. Where you're at now, you really got to think about finances. Let the f*ckers throw you out if needbe and get a really good package, but don't make it easy for them. Meanwhile check out your health insurance options. Good luck!
this drug won't be a stand alone tx, as far as we know. Not for many more yrs. THe trials are not for stand alone med, per what has been posted here by the participant. So, we don't know if it will work as a stand alone (is not been tested as such), hence, we won't know if it will give SVR by itself, less side effects and how long it will have to be taken. When it comes out, yrs from now, it will be accompanied by the same drugs people are trying to avoid. Since, according to some studies, the side effects appear within the first 6 months, and statistics don't show a big increase in most of them the longer you treat, it is still one big guessing game, whether things will be easier.
You don't know what Dr. J will say. He might tell you to quit earlier. In any event, you'll be paying for peace of mind instead of second guessing yourself and your doctor. I had quite a number of surprises regarding tx length when I talked to my doctors. Seems like you've gone too far down the road not to keep the appointment. Anyway, you're gonna deprive us of what should be a really interesting post if you do :)
-- Jim
-- Jim
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