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 after the vx is withdrawn, and if there was minimal undetected VL, then it is the regular tx that would have achieved the SVR.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 after the vx is withdrawn, and if there was minimal undetected VL, then it is the regular tx that would have achieved the SVR.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.
I just visited with a Hep Doc in Seattle, he came with great references and seemed knowledgeable, although I'm not sure I was all that impressed. He did talk about VX950 tho and believes it will be another drug in what will become a "cocktail" (skip the vodka) for those of us who try and fail. He said he did not want me to start ANY tx again because there was growing concern among infectious disease docs that all the IFN we are taking is breeding IFN resistant hep c viruses inside our blood, so he said hang tough and thought I should be able to give VX a try by the end of next year.....IF it works in these first trials.
Now, who in their freakin right mind would not want to just take a VX pill twice a day without any sx for about 6 months and then be cured? But for many years to come, he said VX will be most likely administered in conjunction (junction) with peg and riba. We are all at the beginning of the arc of refining the tx for Hep C, I always was a rebel, but this time, damn, why could'nt I have been slower?, so the doc said we will all do a lot of waiting. And yes, it does mean we may go down a stage or two,liver wise, but he convinced me that was a better choice than feeding the viruses more IFN to make them even more resistant to VX. Just his opinion. Personally, I'm confused as hell, but that is listed as a side effect of hep C, isn't it?
take care
Willow
Now, who in their freakin right mind would not want to just take a VX pill twice a day without any sx for about 6 months and then be cured? But for many years to come, he said VX will be most likely administered in conjunction (junction) with peg and riba. We are all at the beginning of the arc of refining the tx for Hep C, I always was a rebel, but this time, damn, why could'nt I have been slower?, so the doc said we will all do a lot of waiting. And yes, it does mean we may go down a stage or two,liver wise, but he convinced me that was a better choice than feeding the viruses more IFN to make them even more resistant to VX. Just his opinion. Personally, I'm confused as hell, but that is listed as a side effect of hep C, isn't it?
take care
Willow
See Dr. J. or you will be kicking and second guessing yourself forever. Sh*t I just paid $300 to speak to a stink*ing SKIN doctor, can you believe. But this is your LIVER. From what I heard, he is very personable and I'm sure will take the time to answer your questions. As to the insurance, Kalio has a good suggestion. Call the major carriers in your state directly and find out what self-insured options are available to you BEFORE you leave your job. Hep C aside, you don't want to be without ANY lapse medical insurance, especially with all you have going on your plate including the thyroid issue. You may be surprised to find out that your state offers pretty decent and reasonable plans. Sorry things aren't working at work but maybe things will look better soon.
-- Jim
-- Jim
BTW it's not unheard of for patients to make payment arrangements with their doctor. I'm sure the office would like to hear about it *before* the visit but I don't think anyone is going to throw you in hep c jail if you discuss that post visit.
-- Jim
-- Jim
jim,
mind sharing what your skin dr said? i am still having some sun sense, psoriasis and rosacrea. bothers the heck out of me and am worried how long it will last. i still have some short term memory problems. scary.
thanks. bobby
on vx950. i am still waiting for 6 mo pcr but me and my hepatologist feel vx 950 will be the magic bullet if no svr. if the virus is deprived of the food it needs to live and cannot replicate it follows it must go away. with no sides if it takes 6 months or a year as a mono tx it is still 100% better than peg/riba and i hope this will be the final result. i hope that is in the stars.
apparantly major drug companies and investors are willing to put hundreds of millions up conforts me.
mind sharing what your skin dr said? i am still having some sun sense, psoriasis and rosacrea. bothers the heck out of me and am worried how long it will last. i still have some short term memory problems. scary.
thanks. bobby
on vx950. i am still waiting for 6 mo pcr but me and my hepatologist feel vx 950 will be the magic bullet if no svr. if the virus is deprived of the food it needs to live and cannot replicate it follows it must go away. with no sides if it takes 6 months or a year as a mono tx it is still 100% better than peg/riba and i hope this will be the final result. i hope that is in the stars.
apparantly major drug companies and investors are willing to put hundreds of millions up conforts me.
VX-950
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.
Ron
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.
Ron
Sure. Just like the three derms before him, he changed my topical regimen around. This is not unusual for derms as no two ever seem to agree on ANYTHING including diagnosis. Let me know if you want to know skin regimen and I'll post. He did suggest going on doxycycline or the newer low dose version called Oracea? I'm holding off antibiotics for now and waiting to see how the skin reacts to topicals and time. His major suggestion was for IPL (intense pulsed light) which is a sort of laser. He says I need six treatments which would cost me around $3,000 with touch ups a couple of times a year costing around $500 each. That includes face but not my neck which would be extra. Yikes. At this point it's not even the money but I really have to research this more and make sure that's the right direction for now. Hope you feel better soon.
-- Jim
-- Jim
DO get the bx. you will die of worry if you do not.
are you stage 3 now?
i am sorry i missed the post but did you not svr on the first try?
on vx950, what i read is 95% cleared at 1 or 2 weeks and all cleared at 12. much better than peg. there are also many other breakthrough drugs in trials. hope is out there.
bobby
are you stage 3 now?
i am sorry i missed the post but did you not svr on the first try?
on vx950, what i read is 95% cleared at 1 or 2 weeks and all cleared at 12. much better than peg. there are also many other breakthrough drugs in trials. hope is out there.
bobby
You are correct. The viral clearance in the Vertex trial was SIGNIFICANTLY better and fast than with the current combo drugs. How this will translate into SVR data is what we are all waiting for.
-- Jim
-- Jim
GOD you are right what about my thyroid meds, eeeek. You know what hell I've gone through with this job...my GOD I want to leave and get something else.....
I hate them here with such a passion these disgusting perverted pigs I just can't tell you.
$600 to Dr. J is to get him to approve the 72 weeks....my doctor can't (won't) take responsibility as he said he is a GI and he can't ( I guess I could sue him if something seriously goes wrong) without a second opinion. That's all. So basically it IS going for me to just ask a few questions and then leave and never see him again.
If I do quit on 8/18 like I was supposed to originally...maybe it will be long enough. But I'll have to do something about the thyroid and my KIDS insurance oh man.
WHY is this happening? All of the Paxill in the world can't help me now.
I hate them here with such a passion these disgusting perverted pigs I just can't tell you.
$600 to Dr. J is to get him to approve the 72 weeks....my doctor can't (won't) take responsibility as he said he is a GI and he can't ( I guess I could sue him if something seriously goes wrong) without a second opinion. That's all. So basically it IS going for me to just ask a few questions and then leave and never see him again.
If I do quit on 8/18 like I was supposed to originally...maybe it will be long enough. But I'll have to do something about the thyroid and my KIDS insurance oh man.
WHY is this happening? All of the Paxill in the world can't help me now.
Said: When it comes out, yrs from now, it will be accompanied by the same drugs people are trying to avoid.
Bingo...that is why I don't let any of this drive me nuts. Yes it appears to give better odds to clear quicker but...there already is a 50% chance for a geno 1 to clear with the current meds.
I worry that people who could treat now and clear think...wow I'll just wait for these new easier and quicker drugs when in reality they could be risking more liver damage and a much harder chance at SVR years from now when / IF it does come out for general use in tx.
I personally consider a 50/50 chance of beating this now with the current drugs and duration a pretty good chance (even if in some cases we have to extend).
Bingo...that is why I don't let any of this drive me nuts. Yes it appears to give better odds to clear quicker but...there already is a 50% chance for a geno 1 to clear with the current meds.
I worry that people who could treat now and clear think...wow I'll just wait for these new easier and quicker drugs when in reality they could be risking more liver damage and a much harder chance at SVR years from now when / IF it does come out for general use in tx.
I personally consider a 50/50 chance of beating this now with the current drugs and duration a pretty good chance (even if in some cases we have to extend).
I agree that most side effects occur within the first six months but at least with me -- and many others I see posting -- it is the accumulation of these sides *over time* that is the killer. Vertex combined with riba and peg potentially could shorten treatment to 12 weeks with better SVR rates. To me, there is a SIGNIFICANT difference between treating 12 versus 48 or more weeks, even with the same drugs. Significant maybe not in terms of the number of sides but the severity of the sides and what I would imagine to be the probablity of those sides becoming chronic or even permanent. It should also be noted that Vertex is either currently -- or very shortly -- being trialed WITHOUT ribavirin in Europe. Should those results come in positive, look for riba to be dropped faster than a hot potatoe in follow-up American trials.
-- Jim
-- Jim
Although many do UND by wk 12, not all do. It would be interesting to see if there is any correlation between base PCR and UND by wk 12. At 72 mil base PCR, I figured the expected 2 log drop by wk 12 might be optimistic and was please to see a 1.6 log drop despite reduced riba for 8 of the 12 wks.
The real disappointment came when I learned that PCR actually increased by 0.5 log between wks 12 and 24.
As for trusting in the Lord, I've come to believe that sometimes I must but my faith that He will guide the docs to help where my faith may not be strong enough to receive His healing totally upon belief.
The real disappointment came when I learned that PCR actually increased by 0.5 log between wks 12 and 24.
As for trusting in the Lord, I've come to believe that sometimes I must but my faith that He will guide the docs to help where my faith may not be strong enough to receive His healing totally upon belief.
I'd like to add that my major autoimmune skin issues didn't emerge until around week 14 of treatment. Had I only treated 12 weeks instead of my 54, I'm convinced I wouldn't have the problems I'm still having 19 weeks post treatment.
-- Jim
-- Jim
but you don't know that for sure, of course. The ball could have been set in motion already and even if you stop at wk 12, it still would have happen. Like said, a lot of guessing, for many yrs to come.
I stopped the meds at 74 wks and continued shedding hair for months afterwards, what was already started, could not come to a screeching halt.
I stopped the meds at 74 wks and continued shedding hair for months afterwards, what was already started, could not come to a screeching halt.
Count me as one a little more optomistic then most of you. There is a better chance that vx-950 will work as monothearpy than with current drugs. I have spent sometime talking to people involved with the FDA approval process and vertex is doing what they need to do to get that approval as soon as possible. They understand the huge loss the company reported and what they need to do to keep their investors happy. As someone at the company said to me, A person could always use vx-950 as mono if they wanted to.
Ron
Ron
What information is the idea VX950 will work as monotherapy based on? Just wanting it to be true or saying it is so isn't enough, there is no data showing this might be true that I can find, they are testing VX950 WITH IFN/Riba at this point and trials using it alone haven't even begun yet, so who is saying it could work alone? The only time you hear this claim is from those interested in the stock prices and is based on rumors and speculation not on fact. I have looked high and low and can't find any evidence that VX950 would work as a monotherapy or even that it will work WITH IfN/Riba. Where are you getting this information? Please share it because the only people I find saying this are those who are hoping to cash in on their stocks or eouraging people to buy those stocks. My doctor told me there isn't any information available yet to back up these claims. I want it to be true too but I need evidence.
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