Aa
ROCHE - r1626 trials
I had just read the results of the r1626 phase 1 trials. So far this drug has demonstrated more viral reduction that VX-950. a PHASE 2 trial is getting underway that will add PEG+RIB to the mix. Has anyone been involved in the r1626 trials or know where I can get more information? Roche does not publish much information about it on their website.
interesting speculations, I must say. Who really knows? could be or not. You can keep tab on details while on tx? can you spare some of those brain cells and share with us? I can hardly keep up with my bills!
Dear mr apk, If you're not the vertex man, great. Have a good laugh, enjoy your excellent performance during the trial, and especially your 'most fortunate' assignment to the 24 week group. Apologies and congratulations a thousand times over.
And if you are the vertex man, you might want to start keeping closer tabs on the details of what you say here for consistency's sake. Maybe start a spreadsheet with all of your posts categorized by subject matter? That way any particular subject that has been previously discussed can be checked prior to posting to maintain consistency with future posts. Makes for a more palatable story in the end. ;-)
In the meantime, I'll continue to slog away with my treatment, as I'm sure you...will too? At least for a few more weeks anyway.
Either way, please don't take it personally. Always remember "it's just the internet, man."
And if you are the vertex man, you might want to start keeping closer tabs on the details of what you say here for consistency's sake. Maybe start a spreadsheet with all of your posts categorized by subject matter? That way any particular subject that has been previously discussed can be checked prior to posting to maintain consistency with future posts. Makes for a more palatable story in the end. ;-)
In the meantime, I'll continue to slog away with my treatment, as I'm sure you...will too? At least for a few more weeks anyway.
Either way, please don't take it personally. Always remember "it's just the internet, man."
If your post above was not so deeply deluded, it would be funny. I've said all I want to say on this. It seems others on this thread have seen the same things in your posts here as have I. Please take your misguided conspiracy theories elsewhere.
apk quote: "I'm not interested in some petty argument about the nature of taste. Someone posted here that I was clearly not dosing with VX based on a taste test and some weak inductive logic. Not so, as we now know."
Oh, and we know it's so simply because you say so? Sorry, but that doesn't work for me.
"What mremeet appears to be saying is that despite having made that agreement, a subject may choose to drop out of the trial and then to do what they wish if they don't like the group they are in. 24 week [12 + 12] subjects could find an external source of SOC for an additional 24 weeks. 48 week subjects could choose to stop SOC at 24 weeks. Self interest rules!"
Nonsense. First off, I'm perfectly capable of speaking for myself. I don't need you to misinterpret, 'reformulate' and broadcast to others what I've said in a vain attempt to divert attention away from yourself while suggesting I'm some sort of bad guy. I never said you or anyone else should do as you've suggested above. Nor did I say I was considering changing my assigned group (whatever that might be). All I did was pose a very simple question to you based on the clear and obvious *facts*. If that question blows your mind even just by simply reading it, or if it's opened up some kind of bewildering and deeply troubling cognitive pandora's box for you...then I suggest you stick to the Disney channel. And also, you don't need to concern yourself with what I might or might not be suggesting to other people. That's my business, not yours. When I signed the agreement you referenced above, I never agreed in writing or verbally to be muzzled during the trial, nor to not discuss the full details with others, nor to not exchange information with other participants, nor to forgo my basic first amendment rights. I'm absolutely free to speak openly and extensively about any and all of my experiences, thoughts and musings pertaining to this trial. And if you can't handle that, then that's your problem, not mine. Although it's interesting to note that you so deeply object to me discussing the mere possibility of negative ramifications arising as a consequence of stopping treatment at 24 weeks with others here, much less the logical possibility that emerges from that. But we'll get back to that later...
"In each case, these subjects would be lost to the trial population. The more subjects that are lost to the population, the weaker are the final data derived from the trial. The weaker the results, the longer it may take to get the drug into the hands of heppers who need it [assuming the drug is shown to improve the conditions and/or results of tx, of course]. If my sticking with the agreement helps the quantity and quality of the results, then that's a good thing for everyone, me included."
Well, speaking purely hypothetically: if a study participant was assigned to the 24 week group, and then wanted to be extended to 48 weeks, why would that necessarily preclude that person's data from being used in the trial? First off, all the blood work data and any side effects the person experienced during the first 24 weeks is still available and remains *very* useful in and of itself. It doesn't all of sudden cease to be useful or magically evaporate into thin air, does it? Secondly, and more importantly, if that patient remains under the uninterrupted care and supervision of the assigned study center doctor continuously, then why couldn't that person's data simply continue to be collected, used and added into the 48 week group instead? (thereby enlarging the statistical significance of that group, and hence enhancing the quality of that group's data) The data would be precisely the same, and would be held to the exact same standards as any normal 48 week participant - nothing would be different in any way. There's no reason why it couldn't be done, none at all. Now, if vertex or the trial doctor or whomever puts their foot down and declares that patient is no longer a viable source of scientific data (for whatever reason)...well that's up to them, but clearly, it doesn't have to be that way at all. And once again, simply discussing this purely hypothetical situation is in no way an endorsement of, nor a recommendation for anyone to engage in this behavior.
Lastly, there are certain patients who've experienced serious problems during their trial as a consequence of significant negative side effects (like myself, for instance). There are quite a few folks who are/were in the 12 and 24 week groups who experienced early VX dose cessation and/or IFN and/or ribavirin dose reductions and/or experienced a relatively sluggish viral response (taking much longer to go UND than most others), and/or were forced to take immunosuppressants like prednisone/solumedrol to deal with serious allergic reactions, especially during their first 12 weeks (considering rescue drugs were forbidden during this timeframe). In these cases, the notion of blindly stopping at 24 weeks, and especially at 12 weeks, simply because that's the group you were preassigned to isn't so clear cut. In fact, the trial already has provisions for extending treatment beyond 12 weeks for those assigned to that group that meet some or all of the criteria described above. There may be similar provisions for the 24 week group as well. And speaking for someone like myself, if I were to stop at 24 weeks, could my data really be incorporated into the aggregate and used for meaningful predictive purposes? I doubt it. Would it be scientifically sound to compare my (apparently) peculiar situation with early VX cessation, severe rash leading to extensive prednisone/solumedrol/topical steroid usage along with on and off ribavirin dose reductions? I'd say that'd be comparing apples to oranges if you incorporated my data (and subsequent SVR/relapse experience) in with "uneventful" patients who underwent a full course of all drugs with minimal sides.
"Frankly, there would need to be a compelling case that extending SOC beyond 24 weeks after combo therapy with VX950 would increase my chance of SVR. Obviously, there is no data and no basis for such a decision. Just because this is the current thinking for SOC does not mean is is also conveneintly true for VX950 in combo with SOC. This trial is designed to yield initial data on VX950 therapy in combo with SOC, and until it does, there is nothing but assumption and opinion."
This is just an absolutely silly thing to say. On the one hand you're saying that there would have to be a compelling case to extend beyond 24 weeks in order to get your SVR. But on the other hand you say there is no data or basis for such a decision. Therefore! You've decided that until that data exists, it's pure assumption or opinion to suggest you'd be better off with 48 weeks then 24 weeks. Let me tell you something that isn't pure assumption and opinion - your odds of SVR-ing WILL be higher with 48 weeks of treatment, no matter how high the 24 week SVR rate may (or may not) turn out to be. Secondly, just as there is no data or basis for asserting that more than 24 weeks is required, obviously there isn't a single lick of evidence (yet) that a mere 12(VX+SOC)+12(SOC) weeks is all that's going to be required for a patient meeting your specific criteria to SVR (or any other criteria, for that matter). Simply put, the reason Vertex has 12, 24 and 48 week VX groups and is stopping treatment at these various intervals within these groups, is because they want to see what will happen. The reason they want to see what will happen, is because they don't know what's going to happen. And the reason they don't know what's going to happen, is because no one has ever been to that point before - ever.
"It took me most of the last year since dx to learn a little and to wrestle this problem down to the decision I've made. Forgive me if I didn't post very much on this process, but it was intensely personal and difficult for me. I'm in my 50's and have never been seriously ill before. I had never had cause to question my ability to keep on doing what I'd been doing for the past 20 years or so. My near-adult children had never seen me ill. My wife could rely on me to be there no matter what. As we all know, all that changed."
That's fine that you've made a personal decision, and that's certainly your perogative. But it's curious you're not so private with every other aspect of your care. Like everyone else here, you've come to a (worldwide) public forum to openly discuss your health and treatment situation. Details including your sex, age, marital/family status, VL, genotype, LFT's, fibrosis scoring, trial experiences etc etc etc. You've not had a single problem openly discussing any and all of these details, why would the issues arising concerning 24-48 wk duration be so sacrosanct, private and verboten for even the most cursory discussion? Furthermore, for some strange reason not only is that *particular* concept verboten for discussion, extreme happiness with zero reservation/concern is expressed for being in the 24 week group. That doesn't make sense.
Let me finally come to the point. Myself, and perhaps a few others here think you're fishy. We've been carefully watching and making note of what you've been saying basically since you got here. You've tripped up on several occasions and contradicted yourself. Did you know that? You haven't been keeping your story straight. Not only that, you came here only after other trial participants were here first and began discussing some sensitive details of the trial. Vertex then found out about this particular forum and began monitoring it. Did you know that? Not only did they monitor it, there are a few participants that were actually repeatedly yelled at by their study centers and chastised for discussing certain details/concepts about the trial here (after Vertex contacted them directly and told them of this forum and what was said on it). In fact, I'm almost certain I'll be hearing about this post on my next appointment. Only after that did you emerge, and curiously you were in front of all of us, had sophisticated knowledge of HCV, its treatment, and especially of Vertex itself (more than anyone else here). Since you had started treatment earlier than all of us (although one of the last to arrive here), that was a good thing, because you could then lead the way. You'd then be the first to, as in this case, get to the 24 week mark. Then you could coach us all about how fantastic it would be to be in that group, express zero concerns for possibly failing to SVR with such a short course of treatment, and also thwart/discourage "undesirable conversations" by passing stern moral "dudley do-right" judgments on anyone who might even vaguely discuss placebo detection, offstudy PCR's, or even the hypothetical consequences concerning stopping at 24 vs 48 weeks (especially in regard to someone bearing a risky profile, like yourself). You also showed absolutely zero curiosity in the flavor of your pills and zero interest in offstudy PCR's. You're the only participant I've spoken to that has taken that stance, or that has expressed zero concern about stopping at 24 weeks (prior to me bringing it up). You also went a long way at foo fooing the rash I had earlier and downplaying the likelihood it was being caused by VX (later to be validated by my doctors and the Vertex press release). Then later you relayed your own experience with a rash, but only immediately *after* (almost to the day, if you recall) your VX dosing stopped (conveniently clearing VX of any wrong doing in your case). Even many casual posts, like the first one you made in this thread, testily defending VX in response to a simple/innocuous question concerning the effectiveness of a competing PI under development.
I really don't know if Vertex has put a "company man" here in an effort to manage/manipulate information regarding the effectiveness and potential side effects of VX950. What I do know is that they are definitely monitoring this board. They also stand to make or lose billions of $$$ depending on how this trial goes. I also know that pharmaceutical stock traders are commonly accessing this particular forum for gaining information/insight into the likely future success of VX950 (simply go to nearly any online trader site to verify). What is said on this forum can and does have some direct effect on the short term Vertex stock price. Vertex knows this, the only question is would they go so far as to actually put someone here to help "manage" the situation? And not that that person would be you, heaven forbid!! ;-)
Oh, and we know it's so simply because you say so? Sorry, but that doesn't work for me.
"What mremeet appears to be saying is that despite having made that agreement, a subject may choose to drop out of the trial and then to do what they wish if they don't like the group they are in. 24 week [12 + 12] subjects could find an external source of SOC for an additional 24 weeks. 48 week subjects could choose to stop SOC at 24 weeks. Self interest rules!"
Nonsense. First off, I'm perfectly capable of speaking for myself. I don't need you to misinterpret, 'reformulate' and broadcast to others what I've said in a vain attempt to divert attention away from yourself while suggesting I'm some sort of bad guy. I never said you or anyone else should do as you've suggested above. Nor did I say I was considering changing my assigned group (whatever that might be). All I did was pose a very simple question to you based on the clear and obvious *facts*. If that question blows your mind even just by simply reading it, or if it's opened up some kind of bewildering and deeply troubling cognitive pandora's box for you...then I suggest you stick to the Disney channel. And also, you don't need to concern yourself with what I might or might not be suggesting to other people. That's my business, not yours. When I signed the agreement you referenced above, I never agreed in writing or verbally to be muzzled during the trial, nor to not discuss the full details with others, nor to not exchange information with other participants, nor to forgo my basic first amendment rights. I'm absolutely free to speak openly and extensively about any and all of my experiences, thoughts and musings pertaining to this trial. And if you can't handle that, then that's your problem, not mine. Although it's interesting to note that you so deeply object to me discussing the mere possibility of negative ramifications arising as a consequence of stopping treatment at 24 weeks with others here, much less the logical possibility that emerges from that. But we'll get back to that later...
"In each case, these subjects would be lost to the trial population. The more subjects that are lost to the population, the weaker are the final data derived from the trial. The weaker the results, the longer it may take to get the drug into the hands of heppers who need it [assuming the drug is shown to improve the conditions and/or results of tx, of course]. If my sticking with the agreement helps the quantity and quality of the results, then that's a good thing for everyone, me included."
Well, speaking purely hypothetically: if a study participant was assigned to the 24 week group, and then wanted to be extended to 48 weeks, why would that necessarily preclude that person's data from being used in the trial? First off, all the blood work data and any side effects the person experienced during the first 24 weeks is still available and remains *very* useful in and of itself. It doesn't all of sudden cease to be useful or magically evaporate into thin air, does it? Secondly, and more importantly, if that patient remains under the uninterrupted care and supervision of the assigned study center doctor continuously, then why couldn't that person's data simply continue to be collected, used and added into the 48 week group instead? (thereby enlarging the statistical significance of that group, and hence enhancing the quality of that group's data) The data would be precisely the same, and would be held to the exact same standards as any normal 48 week participant - nothing would be different in any way. There's no reason why it couldn't be done, none at all. Now, if vertex or the trial doctor or whomever puts their foot down and declares that patient is no longer a viable source of scientific data (for whatever reason)...well that's up to them, but clearly, it doesn't have to be that way at all. And once again, simply discussing this purely hypothetical situation is in no way an endorsement of, nor a recommendation for anyone to engage in this behavior.
Lastly, there are certain patients who've experienced serious problems during their trial as a consequence of significant negative side effects (like myself, for instance). There are quite a few folks who are/were in the 12 and 24 week groups who experienced early VX dose cessation and/or IFN and/or ribavirin dose reductions and/or experienced a relatively sluggish viral response (taking much longer to go UND than most others), and/or were forced to take immunosuppressants like prednisone/solumedrol to deal with serious allergic reactions, especially during their first 12 weeks (considering rescue drugs were forbidden during this timeframe). In these cases, the notion of blindly stopping at 24 weeks, and especially at 12 weeks, simply because that's the group you were preassigned to isn't so clear cut. In fact, the trial already has provisions for extending treatment beyond 12 weeks for those assigned to that group that meet some or all of the criteria described above. There may be similar provisions for the 24 week group as well. And speaking for someone like myself, if I were to stop at 24 weeks, could my data really be incorporated into the aggregate and used for meaningful predictive purposes? I doubt it. Would it be scientifically sound to compare my (apparently) peculiar situation with early VX cessation, severe rash leading to extensive prednisone/solumedrol/topical steroid usage along with on and off ribavirin dose reductions? I'd say that'd be comparing apples to oranges if you incorporated my data (and subsequent SVR/relapse experience) in with "uneventful" patients who underwent a full course of all drugs with minimal sides.
"Frankly, there would need to be a compelling case that extending SOC beyond 24 weeks after combo therapy with VX950 would increase my chance of SVR. Obviously, there is no data and no basis for such a decision. Just because this is the current thinking for SOC does not mean is is also conveneintly true for VX950 in combo with SOC. This trial is designed to yield initial data on VX950 therapy in combo with SOC, and until it does, there is nothing but assumption and opinion."
This is just an absolutely silly thing to say. On the one hand you're saying that there would have to be a compelling case to extend beyond 24 weeks in order to get your SVR. But on the other hand you say there is no data or basis for such a decision. Therefore! You've decided that until that data exists, it's pure assumption or opinion to suggest you'd be better off with 48 weeks then 24 weeks. Let me tell you something that isn't pure assumption and opinion - your odds of SVR-ing WILL be higher with 48 weeks of treatment, no matter how high the 24 week SVR rate may (or may not) turn out to be. Secondly, just as there is no data or basis for asserting that more than 24 weeks is required, obviously there isn't a single lick of evidence (yet) that a mere 12(VX+SOC)+12(SOC) weeks is all that's going to be required for a patient meeting your specific criteria to SVR (or any other criteria, for that matter). Simply put, the reason Vertex has 12, 24 and 48 week VX groups and is stopping treatment at these various intervals within these groups, is because they want to see what will happen. The reason they want to see what will happen, is because they don't know what's going to happen. And the reason they don't know what's going to happen, is because no one has ever been to that point before - ever.
"It took me most of the last year since dx to learn a little and to wrestle this problem down to the decision I've made. Forgive me if I didn't post very much on this process, but it was intensely personal and difficult for me. I'm in my 50's and have never been seriously ill before. I had never had cause to question my ability to keep on doing what I'd been doing for the past 20 years or so. My near-adult children had never seen me ill. My wife could rely on me to be there no matter what. As we all know, all that changed."
That's fine that you've made a personal decision, and that's certainly your perogative. But it's curious you're not so private with every other aspect of your care. Like everyone else here, you've come to a (worldwide) public forum to openly discuss your health and treatment situation. Details including your sex, age, marital/family status, VL, genotype, LFT's, fibrosis scoring, trial experiences etc etc etc. You've not had a single problem openly discussing any and all of these details, why would the issues arising concerning 24-48 wk duration be so sacrosanct, private and verboten for even the most cursory discussion? Furthermore, for some strange reason not only is that *particular* concept verboten for discussion, extreme happiness with zero reservation/concern is expressed for being in the 24 week group. That doesn't make sense.
Let me finally come to the point. Myself, and perhaps a few others here think you're fishy. We've been carefully watching and making note of what you've been saying basically since you got here. You've tripped up on several occasions and contradicted yourself. Did you know that? You haven't been keeping your story straight. Not only that, you came here only after other trial participants were here first and began discussing some sensitive details of the trial. Vertex then found out about this particular forum and began monitoring it. Did you know that? Not only did they monitor it, there are a few participants that were actually repeatedly yelled at by their study centers and chastised for discussing certain details/concepts about the trial here (after Vertex contacted them directly and told them of this forum and what was said on it). In fact, I'm almost certain I'll be hearing about this post on my next appointment. Only after that did you emerge, and curiously you were in front of all of us, had sophisticated knowledge of HCV, its treatment, and especially of Vertex itself (more than anyone else here). Since you had started treatment earlier than all of us (although one of the last to arrive here), that was a good thing, because you could then lead the way. You'd then be the first to, as in this case, get to the 24 week mark. Then you could coach us all about how fantastic it would be to be in that group, express zero concerns for possibly failing to SVR with such a short course of treatment, and also thwart/discourage "undesirable conversations" by passing stern moral "dudley do-right" judgments on anyone who might even vaguely discuss placebo detection, offstudy PCR's, or even the hypothetical consequences concerning stopping at 24 vs 48 weeks (especially in regard to someone bearing a risky profile, like yourself). You also showed absolutely zero curiosity in the flavor of your pills and zero interest in offstudy PCR's. You're the only participant I've spoken to that has taken that stance, or that has expressed zero concern about stopping at 24 weeks (prior to me bringing it up). You also went a long way at foo fooing the rash I had earlier and downplaying the likelihood it was being caused by VX (later to be validated by my doctors and the Vertex press release). Then later you relayed your own experience with a rash, but only immediately *after* (almost to the day, if you recall) your VX dosing stopped (conveniently clearing VX of any wrong doing in your case). Even many casual posts, like the first one you made in this thread, testily defending VX in response to a simple/innocuous question concerning the effectiveness of a competing PI under development.
I really don't know if Vertex has put a "company man" here in an effort to manage/manipulate information regarding the effectiveness and potential side effects of VX950. What I do know is that they are definitely monitoring this board. They also stand to make or lose billions of $$$ depending on how this trial goes. I also know that pharmaceutical stock traders are commonly accessing this particular forum for gaining information/insight into the likely future success of VX950 (simply go to nearly any online trader site to verify). What is said on this forum can and does have some direct effect on the short term Vertex stock price. Vertex knows this, the only question is would they go so far as to actually put someone here to help "manage" the situation? And not that that person would be you, heaven forbid!! ;-)
I'm not sure what prompted mremeet's rant. My take was that there was a level of accusation there that was way out of order. I'd had an exchange with mremeet a few months back when he insisted that he had cracked the trial blinding, and that he could tell who was getting VX or placebo. It sounded like pure delusional BS at the time, and history has proved him entirely wrong.
I made a comment a while back 'having skin in the game' with regard to the VX trial. What I meant was that I was not an idle bystander, but a subject IN the trial. The results truly mean something to me! He took this comment to mean I owned stock in Vertex, which I don't.
Frankly, I couldn't spell HCV before being diagnosed mid last year, and had no knowledge of Vertex or VX950 until my doctors suggested that I might be a good candidate.
If someone is looking to push a conspiracy theory about company moles in the board population, I guess that's their paranoid right. If someone accuses me of misrepresentation in anything I have done or said on this board, then they are dead bloody wrong and had better stay clear of me in person.
I made a comment a while back 'having skin in the game' with regard to the VX trial. What I meant was that I was not an idle bystander, but a subject IN the trial. The results truly mean something to me! He took this comment to mean I owned stock in Vertex, which I don't.
Frankly, I couldn't spell HCV before being diagnosed mid last year, and had no knowledge of Vertex or VX950 until my doctors suggested that I might be a good candidate.
If someone is looking to push a conspiracy theory about company moles in the board population, I guess that's their paranoid right. If someone accuses me of misrepresentation in anything I have done or said on this board, then they are dead bloody wrong and had better stay clear of me in person.
Not exactly. The way I read it, the study found that the age of initial HCV infection predicted the time to develop cirrhosis. Patients initially infected at age 50 or older have an average time ti development of cirrhosis of 9.8 years compared with 23.6 years for patients initially infected at a younger age. The abstract was not specific about what 'younger' means, but I'm guessing there is quite a range.
Very valuable study - thanks much for the link, Kalio!
Very valuable study - thanks much for the link, Kalio!
Careful Rev - mremeet's double secret cub scout intel committee may have a dossier on you too. Little sister is watching :-)
PS. one main issue for me was that I did not want to progress past "the point of no return" if I could help it. Our livers can heal ad regenerate up to a point, but not if the damage has been allowed to progress past tht point. That was a critical issue for me, I did not want the damage level to increase and place me in a situation that I was not able to improve. At stage 3, it is pushing the envelope. I read a good article on progression once the damage has gotten to our level, it was an eye opener. I will try to hunt it down for you. Damage can progress quite a bit faster for us at this stage.
I don't mean to scare you, I just know we are in a similar boat and my life was compromised by the disease quite a bit with fatigue,pain, Sicca, etc. etc. so treating seemed the only way to stem the progress. Since I felt lousy anyway, I figured might as well feel lousy but be making progress than feel lousy and knowing it was still harming my liver.
I am glad you are on a time frame to reaccess but waiting until next summer seems like a long time to leave it untreated to me. I would worry that for some reason if you do not qualify as a participant in the possible upcoming trial there, or the doctor can't guarantee you a spot that would leave you behind the eight ball. Will your doctor be the one deciding if you will get in? Will ey let you in with your damage level? I would think criteria would come from outside and your doctor would oversee the trial, but who knows. I just hate to see anyone wait on better things that are not proven yet when there is a tx available now that can help you stop and possibly reverse some of that damage. You have a great attitude and I feel attitude is everything when it comes to dealing with this tx. so you have the main ingredient bagged already!
Im not sure why he is all hung up on the idea of mutations, we all have viral muttions and yours are not worse than other people's, he has no way of guaging that anyway unless he has done some special viral testing that we know nothing about. It is likely you just didn't have enough of a dosage and that is wny you had a breakthrough. I tried to look back and find your tx progression but I couldnt, when did you start tx, at what week did you breakthrough, what dosages were you on? How long did you treat?
Treating brings it's own side effects but for me the effects of HCV on my immune system and liver were far worse. It sounds like you have quite a few sides daily from the disease. Many if not all of the problems I was having resolved on tx. My enzymes have been normal (under 30) for a year now, so even with sides I can rest assured my liver is not being assaulted by this damn virus. even if I dont manage to clear the virus, I have stopped it's progression.
Sorry to butt in and comment on your scene, but I worry about you and decided to say something as we seem to be in a similar situation but doing very different things.
Take care, hope today is a good day.
I am glad you are on a time frame to reaccess but waiting until next summer seems like a long time to leave it untreated to me. I would worry that for some reason if you do not qualify as a participant in the possible upcoming trial there, or the doctor can't guarantee you a spot that would leave you behind the eight ball. Will your doctor be the one deciding if you will get in? Will ey let you in with your damage level? I would think criteria would come from outside and your doctor would oversee the trial, but who knows. I just hate to see anyone wait on better things that are not proven yet when there is a tx available now that can help you stop and possibly reverse some of that damage. You have a great attitude and I feel attitude is everything when it comes to dealing with this tx. so you have the main ingredient bagged already!
Im not sure why he is all hung up on the idea of mutations, we all have viral muttions and yours are not worse than other people's, he has no way of guaging that anyway unless he has done some special viral testing that we know nothing about. It is likely you just didn't have enough of a dosage and that is wny you had a breakthrough. I tried to look back and find your tx progression but I couldnt, when did you start tx, at what week did you breakthrough, what dosages were you on? How long did you treat?
Treating brings it's own side effects but for me the effects of HCV on my immune system and liver were far worse. It sounds like you have quite a few sides daily from the disease. Many if not all of the problems I was having resolved on tx. My enzymes have been normal (under 30) for a year now, so even with sides I can rest assured my liver is not being assaulted by this damn virus. even if I dont manage to clear the virus, I have stopped it's progression.
Sorry to butt in and comment on your scene, but I worry about you and decided to say something as we seem to be in a similar situation but doing very different things.
Take care, hope today is a good day.
I have a silly question. Those of you that are considering "extending treatment" on your own...does that mean your insurance will pick up the tab for the remaining treatment? I know mine wouldn't. You'd be dropping out of the study in this case...correct?
Personally, I agreed to participate in the study and I intend to follow the protocol (barring any unbearable sides). As apk said, the decision has been made. There's a person in my study group that was thinking about quitting as soon the first 12 weeks of vx dosing were finished. He's still hanging in there at week 16 (like me), maybe until he gets unblinded...I'm not sure.
mremeet...won't you be getting unblinded soon? I know you are already on the vertex, but I was curious about which arm and your viral load. I've also been interested in the "taste" discussion. Considering there was no bitterness to my vx pills, I've always assumed I'm in the control group. However my Dr. said he is very confident that I'm responding well to treatment, which is the bottom line.
Best of luck to all of you no matter what you decide!!!
Personally, I agreed to participate in the study and I intend to follow the protocol (barring any unbearable sides). As apk said, the decision has been made. There's a person in my study group that was thinking about quitting as soon the first 12 weeks of vx dosing were finished. He's still hanging in there at week 16 (like me), maybe until he gets unblinded...I'm not sure.
mremeet...won't you be getting unblinded soon? I know you are already on the vertex, but I was curious about which arm and your viral load. I've also been interested in the "taste" discussion. Considering there was no bitterness to my vx pills, I've always assumed I'm in the control group. However my Dr. said he is very confident that I'm responding well to treatment, which is the bottom line.
Best of luck to all of you no matter what you decide!!!
My doc's greatest reservation was that maintenance would cause MORE mutations and he thought I could wait the 6 months or so for VX950. He seems to be certain that the University would become accredited as a clinical trial site.
Your post echoes so many of my own fears about my rapid progression and you are exactly right about maintenance stopping some of the progression for a while. If I cannot be enrolled in a trial by this summer, then it is maintenance for me until VX950 is available at a trial somewhere close to me.
I have to make a confession, it is sometimes easier to place hopes in a drug like VX than to face the prospect of going back on maintenance. But I truly believe my doctor is giving me his best advice right now, and he has said that we would reassess my situation every six months. So, I'm here waiting until the first of the year to hear from ole Doc Scott again regarding VX and when, and if, it might be available to me. If not, then in March I will go on maintenance.
Ole Doc Scott was pretty freaked out mutations against IFN, but as times goes by and my fatigue, nauseau gets worse, he is beginning to think along the lines of maintenance. He seems to be monitoring my appetite and weight as a gauge. So far I am still a bit plump, BMI is high and am walking every day. But it gets harder and I get out of breath quicker, so we shall see. I wait for January with anticipation of what, I am not exactly sure.
Willow
Your post echoes so many of my own fears about my rapid progression and you are exactly right about maintenance stopping some of the progression for a while. If I cannot be enrolled in a trial by this summer, then it is maintenance for me until VX950 is available at a trial somewhere close to me.
I have to make a confession, it is sometimes easier to place hopes in a drug like VX than to face the prospect of going back on maintenance. But I truly believe my doctor is giving me his best advice right now, and he has said that we would reassess my situation every six months. So, I'm here waiting until the first of the year to hear from ole Doc Scott again regarding VX and when, and if, it might be available to me. If not, then in March I will go on maintenance.
Ole Doc Scott was pretty freaked out mutations against IFN, but as times goes by and my fatigue, nauseau gets worse, he is beginning to think along the lines of maintenance. He seems to be monitoring my appetite and weight as a gauge. So far I am still a bit plump, BMI is high and am walking every day. But it gets harder and I get out of breath quicker, so we shall see. I wait for January with anticipation of what, I am not exactly sure.
Willow
I guess my worry is that your virus is not suppressed and with our level of damage they say it can progress faster. I thought maybe IFN was medically ruled out for some reason. Im glad that isn't the case. Sicca syndrome is caused by HCV also, I have it as do many of us with this virus, so it could be due to that and not IFN, particularly if you still have it and are off IFN for some time now.
My understanding of it is that we all have mutations/quasi species, breakthrough or not. I wonder why he would talk you out of maint. as that is what I have been encouraged to do by several doctors should this tx fail due to my sustantial damage.
I can understand not wanting to use maint. due to sides but I wonder if it wouldn't be a toss up to the sides caused by HCV and your level of liver damage.
My worry is that time is going by and the pipeline treatments are at least several years away, even VX. You are symptomatic now which worries me. If you are slated to be in an upcoming trial that would be 2007, right? Has he assured you you would fit the trial criteria and that you will be a candidate? My damage seemed to progress rapidly once it got started so I don't feel I can afford to pass on IFN. It does seem to have already improved my liver damage using it for the last year+.
If you are able to pull back the damage somewhat with maintenance, your chances of success with future treatments is improved. Did the doctor suggest you try tx again using a different IFN or increased dosing?
My understanding of it is that we all have mutations/quasi species, breakthrough or not. I wonder why he would talk you out of maint. as that is what I have been encouraged to do by several doctors should this tx fail due to my sustantial damage.
I can understand not wanting to use maint. due to sides but I wonder if it wouldn't be a toss up to the sides caused by HCV and your level of liver damage.
My worry is that time is going by and the pipeline treatments are at least several years away, even VX. You are symptomatic now which worries me. If you are slated to be in an upcoming trial that would be 2007, right? Has he assured you you would fit the trial criteria and that you will be a candidate? My damage seemed to progress rapidly once it got started so I don't feel I can afford to pass on IFN. It does seem to have already improved my liver damage using it for the last year+.
If you are able to pull back the damage somewhat with maintenance, your chances of success with future treatments is improved. Did the doctor suggest you try tx again using a different IFN or increased dosing?
Ultimately the decision to go along with the duration of any of the 12, 24 and 48 wk groups you're assigned to is up to the individual patient. The patient has the option at any time to withdraw consent from the trial and stop, shorten or *extend* SOC treatment beyond what was originally dictated in your group.
And please don't misunderstand what I said to apk. I'm not coaching him to extend treatment beyond his assigned group, nor attempting to seed him with doubt because of his "health condition". I just wanted to hear his responses to the referenced questions and a few more I have for him. I just think he's an interesting fella, and I'd like to hear what he has to say...that's all. ;)
And please don't misunderstand what I said to apk. I'm not coaching him to extend treatment beyond his assigned group, nor attempting to seed him with doubt because of his "health condition". I just wanted to hear his responses to the referenced questions and a few more I have for him. I just think he's an interesting fella, and I'd like to hear what he has to say...that's all. ;)
Wow, what prompted the harsh words for khaos? Perhaps you did not mean them to be harsh, but they came across that way to me. In the ongoing argument between polymerease vs. protease, my doc and my daughter (almost a doc) both agree, protease, especially Vertex, has done the job consistenly in two trials now and VX950 will be my next chance to treat.
Being a stage 3, I experience an urgency to treat at times and I deal with it by researching and for laughs, I follow the boards of a FEW biotech companies working on Hep C drugs. Makes me feel better to read that Vertex recieves 25 million in payments from here and there to stay funded to keep workin on VX950 to save my butt someday.
But those boards, they are full of folks who mostly do not give a rat about which product will work. Some of them buy bits of the future and pay to bet that Vertex will fail. I work out my frustration by trying to post useful research and empirical evidence from our experiences, but I am still just "revenue opportunities" to them. I have grown a thick skin, but am still wondering why you burst out with the slightly harsh, cautionary words to APkhaos.
Jeez, we all know what a **** shoot the virus has set up for us. Most of us are getting by every day on a little hope and a few laughs and the enjoyment of reading about the small success experienced, even briefly, by our peers. Makes my day, anyway.
Willow
Being a stage 3, I experience an urgency to treat at times and I deal with it by researching and for laughs, I follow the boards of a FEW biotech companies working on Hep C drugs. Makes me feel better to read that Vertex recieves 25 million in payments from here and there to stay funded to keep workin on VX950 to save my butt someday.
But those boards, they are full of folks who mostly do not give a rat about which product will work. Some of them buy bits of the future and pay to bet that Vertex will fail. I work out my frustration by trying to post useful research and empirical evidence from our experiences, but I am still just "revenue opportunities" to them. I have grown a thick skin, but am still wondering why you burst out with the slightly harsh, cautionary words to APkhaos.
Jeez, we all know what a **** shoot the virus has set up for us. Most of us are getting by every day on a little hope and a few laughs and the enjoyment of reading about the small success experienced, even briefly, by our peers. Makes my day, anyway.
Willow
I wanted to add -- it also means for me - that in the trial - I will definitely be getting the standard Peg/Rib for 48 weeks (with HCV 796), or - that's what I've been told so far.
K :)
K :)
What in the world makes you think what I said were "harsh words" to apk? Just straight up questions from one hepper to another.
Lastly, *always* remember whilst on the internet: caveat emptor.
Lastly, *always* remember whilst on the internet: caveat emptor.
Keep hanging onto your hope, Willow. It's what we have that we can hold onto. hmmm....I'm going out to eat now, and uh... I hope I don't eat too much and feel like poo afterwards :) Bye!
Not to butt in but isn't the treatment time on the VX trial determined by the trial itself? Even if he was concerned about a shorter SOC tx, there wouldn't be much you could do about it because that was the toss of the dice and the arm you were put in. If you are in an arm that takes SOC tx for 24 weeks, then isnt that your only option? I dont know much about it but I thought I remember you guys talking about that and saying that was the case. (I could have that wrong)
Some did SOC 24 weeks, some did 48 weeks, etc.
Given that it is the trial doctors and not you in control of the time parameters or dosages, there isn't much participants can do about it but remain optimistic and be glad the tx course will end sooner yet hope it will still be successful. If it IS successful with 24 weeks SOC that bodes well for us all.
Some did SOC 24 weeks, some did 48 weeks, etc.
Given that it is the trial doctors and not you in control of the time parameters or dosages, there isn't much participants can do about it but remain optimistic and be glad the tx course will end sooner yet hope it will still be successful. If it IS successful with 24 weeks SOC that bodes well for us all.
Thanks. I'm not totally sure I'm going to be jumping into a treatment again any time soon, but my doctor did want me to keep my options open for a clinical trial if one comes up for a non-responder (a 7 time non-responder??), I would doubt anybody would want me in their trial!!! It might hurt their stats.
Susan
Susan
I agree that I could have used less inflammatory words, but I think most would agree that all of the new drugs deserve the support of the HCV community. What doesn't work for geno 1 may be a silver bullet for geno 3, etc. I do not own Vertex stock, although I might buy some soonish:-)
The VX taste thing was subjective at best. I didn't think we could gain much by diving into the definition of bitter, but they weren't bitter to my taste.
The points you raise about 24 vs 48 weeks of SOC are both true and obvious. There is no data to support the effectiveness of VX + SOC over any period of tx at present. That can only come from the trial data. I've spent many troubled hours over the 24 vs 48 week tx question, and discussed it at length with the Hepetologist and with my family. Not sure where you got the idea that I "haven't even mentioned, nor apparently considered this most obvious possibility" of a relapse and its serious consequences, but your are dead bloody wrong about that, my friend!
At the end of the day, I've chosen to stick with what I agreed to do when I signed up for the trial. There were many factors in that decision, some of which were more family related than anything else.
Having made that decision I'm now acting accordingly. Its really that simple. I'm not utterly confident, naive, or in denial, but nor am I going to revisit a made decision over and over again. There are risks on both sides of this question, and we all have to make choices then live them as strongly as we can.
The VX taste thing was subjective at best. I didn't think we could gain much by diving into the definition of bitter, but they weren't bitter to my taste.
The points you raise about 24 vs 48 weeks of SOC are both true and obvious. There is no data to support the effectiveness of VX + SOC over any period of tx at present. That can only come from the trial data. I've spent many troubled hours over the 24 vs 48 week tx question, and discussed it at length with the Hepetologist and with my family. Not sure where you got the idea that I "haven't even mentioned, nor apparently considered this most obvious possibility" of a relapse and its serious consequences, but your are dead bloody wrong about that, my friend!
At the end of the day, I've chosen to stick with what I agreed to do when I signed up for the trial. There were many factors in that decision, some of which were more family related than anything else.
Having made that decision I'm now acting accordingly. Its really that simple. I'm not utterly confident, naive, or in denial, but nor am I going to revisit a made decision over and over again. There are risks on both sides of this question, and we all have to make choices then live them as strongly as we can.
Buyer beware? Good words, internet or not! First rule of the market, that's for sure. And a good first rule of hep c. But I have so much I am wary of already, I have always taught my children to question authority and practice the same myself. It works just as well for the goose as the gander. Hence, my questioning your post, as I do, silently, any and all posts here.
But I could not live in a world ruled by doubt. So I pick a place to live, full of my virus, full of laughs, full of very complicated research (I have children in professions to help with this), and mostly hope. Being geno 1, stage 3, there isn't much left to me.
My words to you? "You get what you give."
But I could not live in a world ruled by doubt. So I pick a place to live, full of my virus, full of laughs, full of very complicated research (I have children in professions to help with this), and mostly hope. Being geno 1, stage 3, there isn't much left to me.
My words to you? "You get what you give."
Hi Susan. lol - (it is confusing). I can only speak for what it means to me, and that is - it means I can possibly treat (and others can too, if they are eligible NOW) through a trial with a polymerase inhibitor and possibly get an early reduction in viral load (which I've been told is what I want -- the RVR, rapid viral response), and if I DO get that, that hopefully that means I will have a better chance at staying clear (SVR). I've been told about the HCV 796 (poly inhibitor), and I have no clue what all that stuff on the clinical site really means but - from what I have gathered (by coming here, asking my doc, talking to the research coordinator, reading, etc.) it basically means I am taking a shot in the dark (with a trial with a promising poly inhibitor). I might get the real thing; I might get the placebo. If the drugs in trials that are looking promising now (such as VX) keep looking promising and make it to market (which is ALL to be seen yet because there is a LOT more testing that will have to be done), then ... I think it might mean that ......
(holy moly, ya see - it's hard to explain :) ....
But what is expected now (from all I've heard and read and been told by those I think who are on top of things AND by my docs) is that the newer drugs, IF marketed (however long that might take) will be used in conjunction with the standard Peg and Rib and will possibly reduce the treatment time from 48 weeks to something less AND bump the success rate up for Geno 1 from 50% to something much better. But that is all "hearsay", or ... premature, at best. BUT - it's what everyone (docs, patients, tx naives, nonresponders, relapsers, etc.) is HOPING for, I think.
Hope this didn't confuse you more :)
(holy moly, ya see - it's hard to explain :) ....
But what is expected now (from all I've heard and read and been told by those I think who are on top of things AND by my docs) is that the newer drugs, IF marketed (however long that might take) will be used in conjunction with the standard Peg and Rib and will possibly reduce the treatment time from 48 weeks to something less AND bump the success rate up for Geno 1 from 50% to something much better. But that is all "hearsay", or ... premature, at best. BUT - it's what everyone (docs, patients, tx naives, nonresponders, relapsers, etc.) is HOPING for, I think.
Hope this didn't confuse you more :)
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