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Telaprevir, Boceprevir ... Should I TX?
by GreatBird, Nov 25, 2008 05:39PM
Hi All,
It's been an eon since I asked a question here (at least a year--or maybe several), but this is how it stands. I just got the results back from the biopsy I had done last week. It shows absolutely no change (grade and stage wise) since the last biopsy I had in 2002, almost exactly six years ago. (I am a grade 1, stage 2). I have geno 1b. Usually a low-ish VL (under 1mil) and no symptoms (every time I think it's the hep it turns out to be something like menopause or Vit D deficiency or the like). I think I've been infected for almost 50 years (since I was six or seven).
As a TX naive patient, I have been asked to participate in the Boceprevir study. I am very interested in doing this because I have the time with relatively few commitments and the chances of clearance are finally good enough that it's very tempting. I'm also not getting any younger, and am currently insured (even though I got laid off from a job in July). (Not that I need insurance for the study, but it makes me feel more secure about the whole thing.)
So, one of my questions is: is there any advantage of Telaprevir over Boceprevir?
From the little information I've found, it sounds like Boceprevir has fewer sides and they both seem to be enough of a "magic pill" to make the SOC actually work (at least more of the time). My understanding of the Boceprevir trial is that of the three arms, if I end up on the non-PI arm and officially don't clear, at that point they would give me the PI.
I'm looking to the wise and knowledgeable folk on this board to let me know what they think. Should I? Shouldn't I? Is there an advantage to waiting any longer? I've always been adamant about waiting (a looong time ago I got into some rather rough words with folks on this board because my stance was so unpopular), and felt a definite advantage at not messing with my strain of HCV and immune system. So now it's somewhat weird to be standing at the starting line, and I'm a bit uncertain. Your thoughts and opinions, please.
It's been an eon since I asked a question here (at least a year--or maybe several), but this is how it stands. I just got the results back from the biopsy I had done last week. It shows absolutely no change (grade and stage wise) since the last biopsy I had in 2002, almost exactly six years ago. (I am a grade 1, stage 2). I have geno 1b. Usually a low-ish VL (under 1mil) and no symptoms (every time I think it's the hep it turns out to be something like menopause or Vit D deficiency or the like). I think I've been infected for almost 50 years (since I was six or seven).
As a TX naive patient, I have been asked to participate in the Boceprevir study. I am very interested in doing this because I have the time with relatively few commitments and the chances of clearance are finally good enough that it's very tempting. I'm also not getting any younger, and am currently insured (even though I got laid off from a job in July). (Not that I need insurance for the study, but it makes me feel more secure about the whole thing.)
So, one of my questions is: is there any advantage of Telaprevir over Boceprevir?
From the little information I've found, it sounds like Boceprevir has fewer sides and they both seem to be enough of a "magic pill" to make the SOC actually work (at least more of the time). My understanding of the Boceprevir trial is that of the three arms, if I end up on the non-PI arm and officially don't clear, at that point they would give me the PI.
I'm looking to the wise and knowledgeable folk on this board to let me know what they think. Should I? Shouldn't I? Is there an advantage to waiting any longer? I've always been adamant about waiting (a looong time ago I got into some rather rough words with folks on this board because my stance was so unpopular), and felt a definite advantage at not messing with my strain of HCV and immune system. So now it's somewhat weird to be standing at the starting line, and I'm a bit uncertain. Your thoughts and opinions, please.
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I am a person who likes to get things done and over with. So I personally decided to treat right away. Also it seemed to be the best time in my life to do it. Many factors like health, work (or rather not having to work at the moment), future plans, etc... It fit in perfectly into my life where I am at the moment. And then I also had the strong feeling that it was the right thing for me to do now.
If I was in your situation, you already being a person who has been weighing this for years, I would definitely go for the PI's. Be it in a trial or wait for them to come out. I find it really amazing, that it will shorten the time of treatment. These drugs are strong and I find it highly advisable to be exposed as short as necessary. You can always quit the trial, if you are not getting the real thing.
I did not always think this way, but the longer I have been on the forum the more I see ppl having burned out their thyroids and all sorts of other sides. So I believe that the least amount of time one is exposed to these meds, the better.
If you decide to wait until the drugs come out, I would advice to have a new biopsy in already 2 years and to have some less invasive test in 1 year. Just to be sure, as you've had it for such a long time.
The pro's with a trial are the cost and the close monitoring and that they are available now. The cons are no rescue drugs.
The pro's for waiting, is that you will be sure to get the drug and rescue drugs if needed.
All the best,
Marcia
Sad thing is theres some longtime members here that don't even know there is other pi's out there except for telaprevir. As you know there is a very limited amount of slots available for any trial and to pretend that only telaprevir could be the cure all is being a dis-service to alot of fellow heppers. BTW i am not in any way saying you are saying this.
I was also offered the chance at both trials. As a relapser i decided to go with the boceprevir only because of the rescue drugs being allowed. As i needed procrit early on in my first tx, i would rather tx a few extra weeks then risk a dose reduction early on and lower my overall chances of svr.
And no i'm not a shareholder in either stock and think telaprevir is very promising along with a few other new drugs in the pipeline. One thing i do know is there is plenty of us heppers to make all these companys alot of money.
cando
About a year ago I called a research coordinator in my area and was put on a list for upcoming trials. I knew then, the only trial I would accept would be the Vertex Telaprevir. After many hours of researching and reading this board I choose this one, because treatment time could be 6 months, it has a 70% (?) success rate, and there is no placebo. Also I am getting older and I gather your age has something to do with clearing the virus. Plus I want to do this while I am still strong. Another reason is the treatment is free.
Lots of things to consider. The timing in my life is right, because I am semi retired now and working is not a issue. Most importantly, it bothers me deeply knowing the virus is there. I want to be rid of it. I always said I would not treat unless they called me. Now they have, and its time to treat. Guess I got lucky, for they made my decision easier to make. Even then I wonder if its the right thing.
After all these years of deciding not to treat, what has made you consider possible treatment?
It's not that I wasn't going to treat. The question was when. I needed the time. The opportunity. And I needed to be able to trust the outcome.
Considering I've always been a-symptomatic with a relatively healthy liver, I've never been willing to go with 50/50 odds. That's just not good enough for all the trouble and potential loss of health that I've seen with the people who were txing.
Up until this past July, I've worked full-time as a television Associate Director. That's the person with the stopwatch who keeps time on shows. You have to be able to make quick calculations and keep everybody aware of what's happening next. It's not the kind of job you can do with brain fog and it worried me that I'd either make some horrendous mistake that would take out a live show, or have to stop and go out on disability which would have been financial ruin to my family, since I was the sole support. (And then maybe not get my job back.)
Then I got laid off in July and my last child went off to college. We moved and have been able to cut way back on expenses. I'm at the age where finding another job in my field isn't likely (which is even an understatement). So, there's a window of opportunity I've never had before.
For several years, my doctor and I been waiting for phase III trials on the VX-950 because that seemed like a good opportunity. I like the idea of being in a trial and working with people who are very knowledgeable about the state of the art in tx and who also are available to me and checking my progress on a very regular and frequent basis. (Diva? Me? Not really. ;) ) I like the idea of free meds (and labs) even though I have insurance.
When I first found out I had HCV, they seemed to be treating it via shotgun method. They weren't pulling people off tx because they weren't clearing. They weren't extending tx either. It was obvious even to me, that there was too much mystery involved. Now they seem to have a much better handle on what they are doing, which includes being better able to predict a patient's outcome.
I want to treat while I'm still in my 50's. I don't like the virus, not because it's bothering me, but because there is always the possibility of passing it on to someone else. And even though I'm relatively healthy with it, there's no guarantee it will always be like this. I have two friends who have died from HCV.
I would like to know what it's like to live without the virus.
Right now, things have fallen into place like a jigsaw puzzle with all the pieces. It makes me feel like the time is right. I haven't started yet, but it's looking good.
But I've waited so long. It's hard to know if it really is time to jump into the pool.
I have felt this way ever since I found out I had it about 20-something years but I was told back then there was no treatment for me. If I could have, I would have treated back then because yes, your age has a bearing on how well you respond to treatment as does how long you have had the virus on board. Unfortunately in my current treatment is still NOT available for non-1 non-cirrhotic HCV infected patients.
In my book treat the sooner the better, esp as the new drugs are available to you.
This year I jumped on a trial; and it has been the best thing I have done. For the first time in 20 years I'm able to do something to really fight the alien and I am currently UND. And that feels GOOD!
All the best with your decision!
Epi :)
PS: I reckon you should go for it!
Can-do-man, excellent point about the rescue drugs. I'm all in favor of them if needed. It bothered me that they were not available for the Teleprevir. I've always been borderline anemic. It's just my genetics. (Sometimes I wonder if that hasn't helped keep the virus at bay.) Doesn't mean I'll have a worse time than anyone else, but it's something to remember.
All really good points, Marcia, and you cited many of the reasons I'm thinking to do it now. The less exposure the better. I *do* like my thyroid. I'm willing for it to take a hit, but only only only if I have my very best shot at getting rid of the hep C.
jacksonblue, glad to hear you've dodged the rash. That does concern me about the teleprevir. I have a small patch of psoraisis (psoriasis) and wonder if that would make me more prone to difficulty . . . or not.
fretboard, i thought that the teleprevir and the Boceprevir both gave early clearance. Do you mean because of the four-week lead-up in the Boceprevir? and yes, you are completely right. some people don't need to treat. but at what point can you really be sure of that?
Yes, like you and Tippy it does bother me to have the virus. My concern is more about passing it on, though.
(You see, I really think there are more virally things we carry that we don't know about. They just haven't figured out what they are yet. Some may be beneficial, some maybe not.)
I have managed to continue working on set and scheduling whilst txing, brain fog and all, and so far I haven't come a cropper. It can be managed, particularly if you are experienced in your role. I know you said you are not currently working but I thought I'd mention that it can be done!
It does seem as though everything is falling in to place for you, in the same way it all fell in to place for me. It's all about timing in this life, and the flow is certainly going your way it seems....
Epi :)
I suspect I will always worry about those things for the rest of my life but it sure feels good to know that I am doing everything I can to help stem the transmission and solve a global health problem!
If it really bothers you that you have HepC, then by all means tx. As far as the BOC, yes you can get a quick UND, but it does have that 4wk lead in, so it will never be as fast as telaprevir can be. This tx is not like anything you've ever been thru, and I don't even know you, but I bet I'm right.lol I had to start to get some peace and quiet from what I was going thru. If not for all the pain and swelling I guess I would still be waiting. Txing will rock your world, so prepare for it and educate yourself. There is absolutely, no way to predict what you are gonna go thru, and there is no way to predict that you don't have to tx. good luck with your decision
All i can comment on is what Telaprevir has done for me. Starting VL 10 million, after 20 days.....UNDETECTABLE. That is all that is important and all I really care about.
I think the jobs are different when you work on a drama vs. what I've done which is news and public affairs programming--most often live. I keep the show segments to time, count in the taped roll-ins, and deal with crazy producers (I'm sure that part is no different ). Actually, for the past four years I was mostly in editing, so I think I lost some of my edge anyway. As it is, I'm about half-retired because of the layoff and being fifty-four in this business is somewhat ancient.
One of my biggest fears after I found out I had HCV was that my kids and the DH also had it, but I was very, very lucky that all those years, all those boo-boos and bandaids, none of it got transmitted. Still, I get worried. Like recently when I was pilling the cat and he scratched me and then the DH, and that sent me into a BIG tizzy. (The DH thought I needed to chill about it--he wasn't worried at all, but guess what. He's getting tested again whether he likes it or not. At least once I clear he is.)
Thanks for the encouragement! Hang tough. And keep 'em on schedule. :)
Are you on one of the clinical trials?
I am in a Vertex trial...just finishing week #24. I didn't get the "rash". I learned that only 9% of patients get the "rash". I did itch a bit but found relief in a nice shea butter cream. I have fatigue and brain fog but most days weren't too bad. I developed some anxiety and appathy around week 10-11 and went on AD's. I did feel better after week 12 but it's hard to say why. I got more sleep as I didn't have to stay up late to take meds after week 12, I went on the AD's and went off the tripple therapy which could have been Telaprevir. My HGB dropped around week 5 or 6 and I took a riba reduction but no rescue drugs. I am still winded but my HGB is on the rise.
In six months I hope to report SVR. I wish you the best in what ever you decide to do.
Gator
I'm in worse shape but still stalling because as a relapser I think I'll need better odds - probably bus 3 so I can at least add alinia, statins and anything else that crops up between now and then.
Willing good to see you here, and thanks for all yours and frijoles help.
willing--yes. i am willing to take the plunge. finally. and truly. ;) thanks for letting me know what is coming down the pipeline. i have had my eyes on VX950 (and the like) for quite some time. it's exciting to see there are more developments. it also seems that they are FINALLY thinking to tailor the tx to at least some variables with each patient instead of treating everyone with the same genotype the same. can you imagine how amazing it will be when they are able to really take an individual's genetic makeup and medical history into account when they devise a cure cocktail?
You will then have both more information on comparative results as well as more latitude which would make treatment more individualized with the right liver specialist.
Watch and Wait requires patience as these drugs come down to the finish line but they're almost there.
As to which is better now, I'd do a lot more independent research but if I had to choose now it would be Telaprevir hands down. They have the head start and just look at all the folks here like Andiamo who already SVR'd with Telaprevir. Seems like Bocaprevir is just getting going.
Docs offer you whatever trials they have slots to fill and not necessarily what's best for you.
Be well,
Jim
GB - yeah, brave new world indeed; think of the level of confusion around here once there's a dozen different options to mix and match...
As far as tx vs bc - my sense is you're making a good choice. . Telaprevir has yet to report anything that tops boceprevir's 74% svr12 from sprint II (and since that's ITT you can expect better odds if you follow though with tx). However, Schering's current edge is likely to be short-lived : Vertex's prove II reported 69% on patients in the T12/PR24 arm and once their 48W data comes in they'll presumably at least match Schering.
With no change in 6 years you may have to to wait to see how the other drugs shake out. I am in a early trial of the polymerase inhibitor R7128. I cleared by week 4 (VL 8 million to UND) and I was still clear at week 24.
The early data showed 88% of geno 1's (naive) cleared at week 4, and 90% of geno 2 and 3 non-responders. It has shown no evidence of viral mutation and had no adverse sides. Unfortunately you still have to take it with peg and riba and get all those sides. It is still early and SVR data is not back. I imagine in 6-9 months that data willbe in for the early arms.
My guess is future trials will shorten the duration of the peg/ riba part to 24 weeks from 48, but that is just a guess. It is not based on anything I have heard. It would be nice if they can lose that part altogether.
Ultimately this is a personal choice and one you have to weigh for yourself. If you are not comfortable wait, if you are comfortable with what is going on then treat. They are making great progress with these new drugs. Just remember that they are still using them with Peg and Riba. Those drugs are not a picnic.
Here is study if you want to read what I referred to on R7128:
http://www.natap.org/2008/AASLD/AASLD_22.htm
However with respect to waiting, you really have to ask yourself what you're waiting for ("Good things might come to those who wait; Not to those who wait too late "). For someone with GB's profile, the odds from BC (lead in + 48) appear to be around 80% and are likely to be at least that for TV/48 based on the prove 2 data. Reasons to wait might be even better odds or shorter - say 24w tx but both of those are far from certain. For example, assuming a generous 90% SVR rate amon the R7128 RVRs still gets you back to the same 80%. Meanwhile the clock keeps ticking , with accompanying fibrosis progression and decreasing SVR odds.
-------------------------------
First, as you stated, one might wait for both better odds and/or shorter treatment duration.
But the other thing is that "watch and wait" doesn't mean necessarily waiting for any particular treatment. In short, one might simply wait to wait, or another way of saying is that one waits because one prefers not treating to treating.
Assuming that the HCV isn't impacting one's health outside the liver, and assuming the liver is being monitored and no progression is noted -- it's very reasonable to simply wait until one reaches a point where treatment might be indicated either because of health factors or liver damage.
In other words not treating is a decision in and of itself to be compared against treating which has its inherent risks. So at the point one decides to treat, then jump in with the best treatment available.
That is in fact what I and many other "waiters" did. I wasn't waiting for Telaprevir or Boceprevir (they didn't exist) -- I waited for many years because I felt the risk of treating outweighed the risks of not treating.
In very, very short -- for some treatment may never be necessary -- and could reasonably withheld until even a more gentle and more effective treatment comes along.
-------------------------------
One last point. If one does make a decision as stage 2 to treat in the near future, then one reason to wait at least for a year or so is to wait for current trial data to mature and for the drugs to come to market. At that point one can not only make a more informed decision about which PI mix to jump into but also partake in individualized treatment including helper drugs, more frequent viral load testing as well as addittives such as Alinia, Statins, and whatever else looks promising at the time.
from the perspective of one still dealing with hcv infection that parenthesized qualification is an important one. H**, we're all dying, and can fully expect each day to get progressively worse - but there's no sense rushing things. To delay tx without good cause, after say 50 or so, seems unwise. The prevailing view of fibrosis progression, as I understand it, is not linear. Past a certain point it picks up sharply with age and fibrosis level eg
http://www.ncbi.nlm.nih.gov/pubmed/14960533
The tx-related 10X aging is also something I experienced, and am not looking forward to, but the alternative looks worse.
stay well.
Bill
Then the pathology reports... I got 3 readings one from a world-class hepatologist, the other from transplant centers at Stanford and Pittsburgh (wanted to make sure). Two of the three agreed with each other and with the previous, standard percutaneous bx (some areas 1 some 2). The third, on the same slides, saw evidence of much more advanced progression with bridging - which would be much more consistent with the fibroscan results.
So go figure... at this point I've run out of experts; and am not really inclined to keep taking out more chunks just to see what stage I'm at (reminds me of that cartoon where Donald Duck destroys the house while chasing a mosquito). The experience has made me more philosophical about what it means to know something..
So when do those 12w test results come in ?
----------------------------------
We are much in general agreement -- although "age 50" could be debated. The disagreement is what is "good cause". Which leads to the reverse your statement which is equally true -- "To treat without good cause, after say --- or so, seems unwise".
We are in a unique point in time where " new drugs should be out in a couple of years" is no longer wishful thinking but the most probably outcome of trials and the subsequent FDA approval process. Waiting a year or so, as not to age ten -- with often the accompanying "outing" of latent autoimmune conditions -- is certainly something for anyone in the treatment decision making process to think about.
-- Jim
How is your life right now in terms of timing? Do you have any windows of opportunity opening soon that might make a year’s Tx any less painful in terms of stress?
As usual, Jim makes some *very* good points for postponement; I haven’t had the opportunity to review any of the abstracts from the November meeting in SF; have you found anything from there that might warrant pushing treatment back for another year?
I dunno, Walt; you might have a chance to rewrite that White House episode; it might be better to use insecticide rather than let D. Duck destroy the whole structure. I wish there was a good answer for you, Willing; I really do.
My 30 day post TMA was RNA negative. The doc decided to nix the 90 day test; said I can wait for the six month, which is due middle of January. I see my PCP nest week; I might ask him to squeeze in enzymes, just for a preview… I was always a high-enzyme guy (~300/180) while RNA positive. This might yield a little info; but like you, I’m not quite sure what I’d do if it was positive :o).
Thanks for the update; it’s always good to hear from you—
Bill
Keith
Re the bxs, I'm now less inclined to trust them as a gold standard and am instead putting more faith into composite measures (what's the trend in platelets, INR, portal/spleen sizes, etc. etc.). Basically - as things start going south evidence should surface..
Keith/All: whereas the costs of delaying tx are a relatively gradual deterioration (in liver and svr odds) the benefits of waiting come in quantum improvements. Opportunities like the current TV/BC trials open and close. Based on the information available for tx-naive, racking up another 3 years of damage while waiting for essentially the same odds after approval does not seem a great move.
Jim: yes, the numbers are just shorthand - but unfortunately the text (and follow up conversations) confirmed discrepancies, both in different samples and in different interpretations. ( The last pathologist was adamant that, even after consulting with a colleague, she just didn't see what the next-to last had seen). I'll try to gather the reports and post them, but, given the choice of readings, I think I like yours the best...
As for the two drugs you mentioned, although I'm not a doctor and my advice is strictly my opinion, I would wait until it's released to the public, for the simple reason that you may go through the torture of the two other mandatory drugs, and get a placebo instead of one of the “miracle” drugs you mentioned. Otherwise... it's up to you. Good luck...
Magnum