Aa
Should I get back on the tx wagon?
Hi everyone...
I'm seeking opinions on whether I should I try treatment again, this time with vx-950. I was in the control group of the Prove 1 trial and responded well to SOC in the beginning..only to relapse at 11 weeks post-tx. I'm able to join a rollover trial in my area which would offer me the real drug this time, however this trial is only for 24 weeks. I would be given 12 weeks of peg + riba + telapravir and then 12 weeks of just peg + riba. Would this be an idiotic move? Would the risk of mutation be too great?
It's hard to know what my odds would be since the drug is unapproved. If 48 weeks of SOC didn't work, why would 24 weeks work? Should I jump at the chance to try the new drug, or should I wait until something is actually approved? (last biopsy showed stage 2-3).
Anyhow, II thought I would troll for opinions and advice here since its been so valuable to me in the past.
I'm seeking opinions on whether I should I try treatment again, this time with vx-950. I was in the control group of the Prove 1 trial and responded well to SOC in the beginning..only to relapse at 11 weeks post-tx. I'm able to join a rollover trial in my area which would offer me the real drug this time, however this trial is only for 24 weeks. I would be given 12 weeks of peg + riba + telapravir and then 12 weeks of just peg + riba. Would this be an idiotic move? Would the risk of mutation be too great?
It's hard to know what my odds would be since the drug is unapproved. If 48 weeks of SOC didn't work, why would 24 weeks work? Should I jump at the chance to try the new drug, or should I wait until something is actually approved? (last biopsy showed stage 2-3).
Anyhow, II thought I would troll for opinions and advice here since its been so valuable to me in the past.
That's pretty interesting that they changed the protocol from 24 weeks VX to 12 weeks, and a blessing for all nonresponders treating with VX in the future. Thanks for letting us know.
Good luck whatever you decide,
dointime.
Good luck whatever you decide,
dointime.
I was in Prove 3 and had relapse (on the no Riba group). My doctor wants to talk to me in April about the possibility of doing 4 drugs (PI in the mix), but I'm not sure yet, which drugs it is he'll be thinking of, what the time frame-i.e. availability of these drugs is, or whether or not it will be in a trial. I'm going to have to wait until April to find out what he's thinking. Susan
Sounds like you're following all leads as you should. Nor sure if a GI is the one to discuss the mutation issue with -- certainly can't hurt -- but if time and resources allow, you might try contacting one or two of the "biggies" and try and come up with some sort of consensus on that. I was under the impression -- hopefully the right impression -- that the mutation issue was more serious if you were an interferon non-responder, but you did respond. That said, frankly I haven't really studied that issue a lot because when I was treating, Telaprevir wasn't ready for prime time yet. As to adding some more SOC after the trial, I suppose there are a number of ways to look at that, however you were their placebo once, weren't you. Still, I'd try and get as much data as possible from the latest non-responder trial -- specifically the group that did 12 and 12. If the results look really good, you may not need more.
-- Jim
-- Jim
-- Jim
-- Jim
I believe the Prove 3 trial for non-responders included an arm with 24 weeks of triple-therapy. I've been speaking with the nurse of the Prove 1 trial and she's been relaying the Dr's message to me (he's out of the country a lot and I haven't spoken to that Dr. directly about this). She said he didn't like the 24 week trial for me one bit and indicated I might get a mutation if I pursued that route. I offered a hypothetical situation where I would do the 24 week trial and then wander off on my own for an extra 24 weeks of SOC - she said that would be much better for me as a patient, but of course they can't make that recommendation. It would be a conflict of interest. The rollover trial is at a different site, and I've been speaking to those people as well. That's why I mentioned discussing with another Dr. altogether!
I'm not really up on the data for prior non-responders, but wasn't that the same as you are now being offered -- 12 triple followed by 12 double? If those results look good and you're guaranteed no placebo -- like Mre stated earlier -- it should be a compelling choice. As a stage 2-3 you could look at it either way -- a little time to wait, or better jump in now when the jumping looks good. These are really tough decisions with no black or white answers but I don't have to tell you that. Did the nurse specifically talk about the viral mutation issue? I was hoping you would be able to air that with your treatment team.
-- Jim
-- Jim
thanks jim...your educated opinion means a lot to me. I might just speak with my old GI about this since he has no interest with any drug co., as opposed to those in the trials. I'm with you on the 72 week thing...that didn't interest me a bit!
I believe that the doctor didn't object to the 12 weeks of vx950 (v. 24 weeks)..it was more about the short duration of peg & riba. His initial recommendation after I relapsed was 72 weeks of SOC. Since I relapsed after 48 weeks of SOC, it didn't make sense to do only 24 weeks of SOC - even with vx950. If this trial was 12 weeks TVR and included either 48 or 72 weeks of SOC, I think he'd be fine with it. It's the potential for viral mutation that worries me the most and I'm not sure if the length of SOC has anything to do with that or not, but that's the message I heard when I spoke with the nurse. And she even mentioned a hypothetical scenario with 12 - 24 weeks of TVR + 72 weeks of SOC as being the full-whammy. But I must say that didn't really interest me!!! It seems that a mutation could occurr regardless of how long the SOC is.
You got to do what you feel comfortable with. Personally, I'd jump at 24 weeks triple over 72 weeks extended SOC, IF I made a decision to treat. As you know, I'm certainly not gung-ho tx for those with little or no liver damage -- but I really don't think you should hold off this particular trial solely because of the drug-resistant thing. Other reasons perhaps, but not that. In fact, you might want to discuss that particular issue with your doctor, or even get an outside consult. All the best in however you decide.
-- Jim
-- Jim
Hi Jim...Thanks for your response...I neglected to add that I was tested again on weeks 24, 28, 36, 48 and then 4 weeks post. All were UND (< 30). By week 11 post-tx I was back up to 1.6 million. It did look like I responded real well (even by day 4) and then it levelled off. (I double-checked my paper-work to make sure I didn't make typ-o). In the past, I didn't want to treat at all..and thought I should wait...even forever! But now, after having gone through 48 weeks for some reason I feel hell-bent on getting rid of this. Not sure why, since I'm asymptomatic. But I'm thinking about waiting and letting someone else be the guinea pig. I just don't want to be fool-hardy and end up with a drug resistant virus. The doc initially suggested 72 weeks of soc when I relapsed; after all that's what's been tested and approved.
treated 1998 intron rib 1year relapsed treated may 04 for 72 weeks pegasys 1200 rib finished sept 05 viral drop 3.2million to 2300 week 12 week week 24 0-50 week 26 negative continued 46 more weeks negative relapsed stage one fibrosis 1998 biopsy done april 2007 for prove 3 stage o doctor says could be sampling error must be some scarring prove 3 results almost identical so far day 1 7110000 start wk1 628000 wk2 418000 wk3 91500 wk4 48300 wk8 6660 wk 12 1520 wk16 76 wk20 under30 detected week 24 neg almost identical pattern to last treatment in arm a prove 3 no chance of treatment working in week 30 now options our quit trial now and wait for vertex to be approved wich been told 3to4 years in canada or continue for 18 more weeks with no chance of treatment working because 46 prior treatment neg then relapse if icontinue on trial now when i relapse i will be offered 12weeks triple drugs and 12 weeks soc been trying to decide for last 4 weeks what to do considering treated 72 weeks in past i dont think i should have to carry on this arm of trial with no chance of it working just to get shot at vertex drug any adice would help regards
It's true that there is the possibility that you could fail treatment again and even possibly end up with a telaprevir resistant strain afterwards. But while that is a possibility, I think it's unlikely. I think the odds are definitely in your favor for successfully treating this time around, and I say that for the following reasons: (1) you're telaprevir naive (thereby ensuring viral responsiveness), (2) you'll be receiving full measures of both IFN AND ribavirin (i.e. ribavirin won't be left out as it was for the vast majority of VX tx failures), (3) you're unlikely to experience dose reductions as a result of anemia/neutropenia (based on your previous experience), and (4) you're likely to be fully responsive to IFN and riba (again, based on your previous experience) which has been shown to be the most critical aspect of successful TVR+SOC therapy.
As to the issue of the trial not dosing telaprevir beyond 12 weeks: At this point in time based on what we've seen in many Prove patients, I strongly suspect that telaprevir's real utility is experienced during the first phase of treatment during the earliest phases of viral clearance. I would suspect the trial coordinators know this already, and that's why "only" 12 weeks of VX950 is planned for phase 3 (and will likely be the normally prescribed duration once FDA approval comes). If the drug's going to work for you, then taking it longer than 12 weeks has probably been found to be superfluous and even contraindicated considering what it does to you side-effectwise. We certainly have a sense at this point that if an UND status is not rapidly achieved during the first 4 weeks and/or is not sustained in the weeks to follow, treatment will be a failure. And an ongoing course of VX950 beyond 12 weeks will not change that. When protease inhibitors are in play, it seems clear that their usefulness is a fleeting thing. Either the shootin' match is over in a matter of days or weeks (in terms of UND status), or the drug gives up the ghost afterwards. There's definitely a window of efficacy, and that window closes well before 12 weeks (much less 24 weeks and beyond). From what we've seen over the past year, the "stereotypical" VX950 SVR has the following profile: they take SOC+TVR, they go UND anywhere from 4 days later to maybe 3 weeks later. Once this happens the virus does not come back, UNDetectability is maintained throughout the remainder of treatment as long as the other drugs are continued. And dose reductions in at least riba are commonly tolerated after an UND status is achieved (again as experienced by myself and many others, including pln). Even taking powerful immunosuppressants like prednisone and solumedrol don't seem to disturb the UND status if the initial "routing out" takes place without interruption (as occurred with myself and charlotte). So in my opinion, I don't believe dosing VX950 beyond 12 weeks is useful, and in fact it's counterproductive when you consider the nasty side effects this drug causes. And if the trial coordinators have decided that the dosage will be 12 weeks for the final phase of testing before FDA approval, I suspect they feel this way as well.
But returning to the issue that the trial will not give you the very best odds of being cured: I agree that the odds are not maximized, but I think they are very good and close to optimal. The 24 week group that received 12 weeks SOC+TVR + 12 weeks SOC has definitely been determined to be the tx sweet spot, and we've seen that borne out here. The only thing more I would want (given my druthers) is maybe riba predosing, doubledosing IFN for the first 2-4 weeks and especially alinia. And if my antiviral performance was excellent (i.e. going UND by week 1 or 2), then personally I wouldn't want to extend beyond 24 weeks. I guess the bottomline is what level of "antiviral-assurance" you feel comfortable with.
Lastly, if you don't mind my asking why is your doctor so adamant against you treating this time around? You state above: "This trial would definitely give me 24 weeks of SOC, but only with 12 weeks of vx-950...and as I stated previously, my study doctor does NOT recommend my doing this." Why does your doctor feel that more than 12 weeks of telaprevir is required to do the job? I know of no evidence that suggests that's true, so I'm curious why he's saying that. Did he explain himself or is it simply the unstated logic that "morer is betterer"? I can see someone wanting maybe 24 or 36 more weeks of SOC added to the 12 week interval of TVR+SOC instead of just 12, that would definitely enhance odds of SVR...but I don't get the logic that continuing TVR beyond 12 weeks would really enhance odds of SVR.
As to the issue of the trial not dosing telaprevir beyond 12 weeks: At this point in time based on what we've seen in many Prove patients, I strongly suspect that telaprevir's real utility is experienced during the first phase of treatment during the earliest phases of viral clearance. I would suspect the trial coordinators know this already, and that's why "only" 12 weeks of VX950 is planned for phase 3 (and will likely be the normally prescribed duration once FDA approval comes). If the drug's going to work for you, then taking it longer than 12 weeks has probably been found to be superfluous and even contraindicated considering what it does to you side-effectwise. We certainly have a sense at this point that if an UND status is not rapidly achieved during the first 4 weeks and/or is not sustained in the weeks to follow, treatment will be a failure. And an ongoing course of VX950 beyond 12 weeks will not change that. When protease inhibitors are in play, it seems clear that their usefulness is a fleeting thing. Either the shootin' match is over in a matter of days or weeks (in terms of UND status), or the drug gives up the ghost afterwards. There's definitely a window of efficacy, and that window closes well before 12 weeks (much less 24 weeks and beyond). From what we've seen over the past year, the "stereotypical" VX950 SVR has the following profile: they take SOC+TVR, they go UND anywhere from 4 days later to maybe 3 weeks later. Once this happens the virus does not come back, UNDetectability is maintained throughout the remainder of treatment as long as the other drugs are continued. And dose reductions in at least riba are commonly tolerated after an UND status is achieved (again as experienced by myself and many others, including pln). Even taking powerful immunosuppressants like prednisone and solumedrol don't seem to disturb the UND status if the initial "routing out" takes place without interruption (as occurred with myself and charlotte). So in my opinion, I don't believe dosing VX950 beyond 12 weeks is useful, and in fact it's counterproductive when you consider the nasty side effects this drug causes. And if the trial coordinators have decided that the dosage will be 12 weeks for the final phase of testing before FDA approval, I suspect they feel this way as well.
But returning to the issue that the trial will not give you the very best odds of being cured: I agree that the odds are not maximized, but I think they are very good and close to optimal. The 24 week group that received 12 weeks SOC+TVR + 12 weeks SOC has definitely been determined to be the tx sweet spot, and we've seen that borne out here. The only thing more I would want (given my druthers) is maybe riba predosing, doubledosing IFN for the first 2-4 weeks and especially alinia. And if my antiviral performance was excellent (i.e. going UND by week 1 or 2), then personally I wouldn't want to extend beyond 24 weeks. I guess the bottomline is what level of "antiviral-assurance" you feel comfortable with.
Lastly, if you don't mind my asking why is your doctor so adamant against you treating this time around? You state above: "This trial would definitely give me 24 weeks of SOC, but only with 12 weeks of vx-950...and as I stated previously, my study doctor does NOT recommend my doing this." Why does your doctor feel that more than 12 weeks of telaprevir is required to do the job? I know of no evidence that suggests that's true, so I'm curious why he's saying that. Did he explain himself or is it simply the unstated logic that "morer is betterer"? I can see someone wanting maybe 24 or 36 more weeks of SOC added to the 12 week interval of TVR+SOC instead of just 12, that would definitely enhance odds of SVR...but I don't get the logic that continuing TVR beyond 12 weeks would really enhance odds of SVR.
To clarify the last paragraph a little -- if you either have signficant liver damage, or believe one should treat the virus early-on regardless of of liver damage -- then I personally wouldn't hesitate on this trial because of its newer protocol. It's a bird in hand, and as mentioned, you may only need 12 weeks of Telaprevir given your intially strong interferon response last time.
At least to me, your viral load curve seemed a bit odd. You started like a super responder and then stalled and sputtered. Curious if you were tested past week 30 and also at EOT (around the time you stopped the drugs). Mention that because I wonder if you might have been intermittently carrying a very low level of virus all along. One reason for testing througout treatment.
But regardless, it seems like something added to the equation -- something as strong as Telaprevir -- could make the difference with someone who initally repsonds as strongly as you do, but I'm no expert in viral kinetics and this would be something to discuss at the highest levels with your medical team, i.e. the doctor directly.
As to your reservations -- 12 weeks instead of 24 -- again you're in uncharted waters because I assume this is a new trial protocol and I'm guessing the reason for the protocol is they hope whatever they lose by the shorter dosing might be gained by fewer dropouts because of the rash. Just a guess here.
Should you do it? Really depends on how bad you want to try and get rid of the virus now as opposed to waiting a few years when hopefully more info is available and it will be out of trial. Personally, I'd wait, but my general position is to wait unless you have signficiant liver damage. If you don't share my position, then I'd say go for it. It's only 24 weeks exposure -- only 12 of Telaprevir -- you said you tolerated tx OK last time? and it seems to offer a reasonable chance of success although certainly no guarantees.
All the best,
-- Jim
But regardless, it seems like something added to the equation -- something as strong as Telaprevir -- could make the difference with someone who initally repsonds as strongly as you do, but I'm no expert in viral kinetics and this would be something to discuss at the highest levels with your medical team, i.e. the doctor directly.
As to your reservations -- 12 weeks instead of 24 -- again you're in uncharted waters because I assume this is a new trial protocol and I'm guessing the reason for the protocol is they hope whatever they lose by the shorter dosing might be gained by fewer dropouts because of the rash. Just a guess here.
Should you do it? Really depends on how bad you want to try and get rid of the virus now as opposed to waiting a few years when hopefully more info is available and it will be out of trial. Personally, I'd wait, but my general position is to wait unless you have signficiant liver damage. If you don't share my position, then I'd say go for it. It's only 24 weeks exposure -- only 12 of Telaprevir -- you said you tolerated tx OK last time? and it seems to offer a reasonable chance of success although certainly no guarantees.
All the best,
-- Jim
I believe you're correct...the nurse for the rollover trial told me yesterday that they changed the protocol from 24 weeks of vx to 12 weeks. She was not sure of the reason but originally this trial was intended to include 24 weeks of triple therapy, not just 12. I'm still vx-950 naive...so I guess I should be extremely careful with my next move.
Somebody correct me if I'm wrong but didn't the Prove3 people (previous non-responders) get 24 weeks of VX950? The 12 x 12 triple therapy has only been done with treatment naive people I think. I don't see how it is appropriate to offer it to you as a previous relapser?
dointime.
dointime.
Thanks everyon! I appreciate your responses. While I'm inclined to go for it, I don't want to jump into a fire!
orleans - I would fall under trial rules...but that doesn't mean I couldn't (unethically of course) break them and continue with an extra 24 weeks of SOC on my own. I've been mulling that option over.
I didn't need rescue meds during my past round of SOC but who knows what would happen this time...especially with the dreaded rash.
kcmike: I responded well in the beginning...it went like this:
Day 1 3,830,000
Day 4 17500
Day 8 16900
Day 15 5348
Day 22 1280
Day 29 318
Day 57 29
Day 71 <30
Day 85(preDose) 29
Day 85(post) <30
Week 16 29
Week 20 <30
Post Tx Wk 11 1,610,000
Those bothersome "29"s should have indicated extending treatment to 72 wks (I think we've determined that from what's been posted on the forum here).
dointime: I appreciate what you're saying..in fact that's pretty much what my trial doctor from Prove 1 said today when I spoke with his nurse. He does NOT recommend that I do this study for only 24 weeks. He believes I would risk a mutation and that I should wait for a longer study. (They're not doing the rollover trial - it's at a different site). His initial recommendation when I relapsed was that I should do it again for 72 weeks w/ SOC (that is the tried and true isn't it?). I agree with your asessment of the situation, but something in me still wants to "go for it".
Libzo: Thanks for your kind and inspiring words! "A second tx is a second chance" - that's basically what my husband said to me. If someone's throwing you a life-line, grab it. Of course that's letting my emotions get in the way of common sense...but you're right..everyone has their own journey to make. I'm just trying to reason through it.
mremeet: Hi there - I hope you're doing well! It really does feel like carpe diem time to me. But I've done a lot of really stupid things in my life during "carpe diem time" - lol! This trial would definitely give me 24 weeks of SOC, but only with 12 weeks of vx-950...and as I stated previously, my study doctor does NOT recommend my doing this. Since I know now that he feels that way..I would feel like a giant idiot if I did it...especially if I did it and it didn't work. However you make a good point about my liver damage. That's always been a point of consternation for me. Three years prior to beginning the trial, my biopsy showed I was a stage 1. The trial screening biopsy, (read by the pathologist) showed stage 3 w/ evolving cirrhosis! The doctor re-read the slide and said I was more of a stage 2 than a 3 after all. He's the one that thinks I should either wait for a longer study w/vertex, wait for a drug to be approved, or retreat with SOC for 72 weeks. He apparently thinks I have time to wait...but nobody knows do they? Thanks for your $0.02!
Foreseegood, FLGuy, sunspot; Thanks for your opinions, I appreciate knowing what your thoughts are on this. It really means a lot to me.
orleans - I would fall under trial rules...but that doesn't mean I couldn't (unethically of course) break them and continue with an extra 24 weeks of SOC on my own. I've been mulling that option over.
I didn't need rescue meds during my past round of SOC but who knows what would happen this time...especially with the dreaded rash.
kcmike: I responded well in the beginning...it went like this:
Day 1 3,830,000
Day 4 17500
Day 8 16900
Day 15 5348
Day 22 1280
Day 29 318
Day 57 29
Day 71 <30
Day 85(preDose) 29
Day 85(post) <30
Week 16 29
Week 20 <30
Post Tx Wk 11 1,610,000
Those bothersome "29"s should have indicated extending treatment to 72 wks (I think we've determined that from what's been posted on the forum here).
dointime: I appreciate what you're saying..in fact that's pretty much what my trial doctor from Prove 1 said today when I spoke with his nurse. He does NOT recommend that I do this study for only 24 weeks. He believes I would risk a mutation and that I should wait for a longer study. (They're not doing the rollover trial - it's at a different site). His initial recommendation when I relapsed was that I should do it again for 72 weeks w/ SOC (that is the tried and true isn't it?). I agree with your asessment of the situation, but something in me still wants to "go for it".
Libzo: Thanks for your kind and inspiring words! "A second tx is a second chance" - that's basically what my husband said to me. If someone's throwing you a life-line, grab it. Of course that's letting my emotions get in the way of common sense...but you're right..everyone has their own journey to make. I'm just trying to reason through it.
mremeet: Hi there - I hope you're doing well! It really does feel like carpe diem time to me. But I've done a lot of really stupid things in my life during "carpe diem time" - lol! This trial would definitely give me 24 weeks of SOC, but only with 12 weeks of vx-950...and as I stated previously, my study doctor does NOT recommend my doing this. Since I know now that he feels that way..I would feel like a giant idiot if I did it...especially if I did it and it didn't work. However you make a good point about my liver damage. That's always been a point of consternation for me. Three years prior to beginning the trial, my biopsy showed I was a stage 1. The trial screening biopsy, (read by the pathologist) showed stage 3 w/ evolving cirrhosis! The doctor re-read the slide and said I was more of a stage 2 than a 3 after all. He's the one that thinks I should either wait for a longer study w/vertex, wait for a drug to be approved, or retreat with SOC for 72 weeks. He apparently thinks I have time to wait...but nobody knows do they? Thanks for your $0.02!
Foreseegood, FLGuy, sunspot; Thanks for your opinions, I appreciate knowing what your thoughts are on this. It really means a lot to me.
As is was reading the post from the top, I was thinking 'Yes, do for it". Then I came to Mr. E's post. He nailed it. Go for it, I would.
for whatever it's worth...I'd do it in your shoes too...that kicker 9-50 in the beginning seems to be the clincher...best of luck with whatever you decide to do...
Since you already know you tolerated the IFN and riba very well (without dose reductions), and you did respond to the drugs and went UND within a reasonable timeframe, chances are you'll perform similarly your second time around. True the telaprevir will add another dimension, and it may not be a pleasant one, but odds are it will be tolerable. Without overanalyzing the whole thing, if I were in your shoes with an F2-F3 liver (which is a significant amount of fibrosis) and a guaranteed opportunity existed for the coveted 24 weeks TVR + SOC treatment (with no possibility of placebo), I'd jump on it. Barring any stupid new trial rules, I'd do it and do it with gusto, again especially considering how extremely well you tolerated your last treatment. There are no guarantees telaprevir will even be FDA approved, you may have to wait considerably longer than you think to get access to something this effective again. By that time will you be a full blown F3?? Maybe even going into cirrhosis?? Does that sound like something you're comfortable with? It's here, it's here now, it works - it's only 24 weeks. Seems to me it's carpe diem time.
Just my $0,02, hoping the best for you whatever you decide.
Just my $0,02, hoping the best for you whatever you decide.
When it came to treatment or trial options, I was clinging to a slippery slope grabbing at any thing. I learned to have faith in my fate. I am also wrong many times. Ok, I am just nuts but I feel everyone has an individual journey to take inspite of and because of their actions. If one door closes, another will surely open - Right? I congratulate you on your great accomplishment of getting through treatment once. I'd go for it but I am not in your shoes - I might be a coward in reality. A second tx is a second chance. Lab-rat - you have been a light for me in the past. Good luck!
I think that anybody who can wait should wait for optimal use of the available drugs - which is not what you'd get on a trial. I know it would be really great if you could do this tx with the VX950 and it worked. But the risk if it doesn't work is that you might blow your chances of ever using the VX again by being left with resistance to it.
You can't know what your particular odds would be ever, but you can know that they would be better under the optimal dosing and individually tailored tx with rescue drugs that you could get after the VX950 is approved.
dointime
You can't know what your particular odds would be ever, but you can know that they would be better under the optimal dosing and individually tailored tx with rescue drugs that you could get after the VX950 is approved.
dointime
Good question by orleans, also would like to ask what your viral curve was during tx. I don't recall what the protocol was regarding RVR/EVR or 2 log drop/UND.
kcmike
kcmike
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