Aa
I was pulled from the trial
I don't feel like saying a lot, but since I was allowed to report when I went on the Vertex trial, then, I'm reporting to you that today, I was pulled from the Vertex trial. I did not get the viral response necessary. I knew it was a chance, but it is still disappointing for me. I am still holding for hopes for all of you currently treating.
Susan
Susan
I think you are right about needing time off tx after all that you have done. 5 weeks on VX should not give you much post tx sides. I felt a world of difference within 24 hours off the VX.
If it is any consolation, they kept me on the VX for 12 weeks and it made no difference. My VL shot up to 100,000 by week 4 and stayed there. I was in Prove2 and treatment naive. So I doubt if you would have cleared had you stayed in the trial for longer, in fact I think you were lucky to be spared that. But I do think it is mean of them not to give you all your VL results now so that you at least know what happened.
I think the situation is more positive than you think. Your VX-resistant variants mostly resolve over a period of 7 months back to wild-type virus, so there is every chance that you can retreat with VX or another PI.
The no-riba arm of the VX trial has already been disclosed by Vertex to be a less effective antiviral tx than the triple therapy. There were 3 of us on no-riba in my group and we all failed, I had breakthrough and the other 2 had relapse.
In addition, you cannot underestimate the power of VX to clear wild-type virus very fast, well within 4 weeks. There's every chance that if you had been on the triple therapy you would have cleared and stayed that way. We both just drew the short straw on the trial, that's all. So don't be downhearted about this outcome but wait and see the next Vertex trial data. They will get this right, and your ordeal will come to an end.
dointime
If it is any consolation, they kept me on the VX for 12 weeks and it made no difference. My VL shot up to 100,000 by week 4 and stayed there. I was in Prove2 and treatment naive. So I doubt if you would have cleared had you stayed in the trial for longer, in fact I think you were lucky to be spared that. But I do think it is mean of them not to give you all your VL results now so that you at least know what happened.
I think the situation is more positive than you think. Your VX-resistant variants mostly resolve over a period of 7 months back to wild-type virus, so there is every chance that you can retreat with VX or another PI.
The no-riba arm of the VX trial has already been disclosed by Vertex to be a less effective antiviral tx than the triple therapy. There were 3 of us on no-riba in my group and we all failed, I had breakthrough and the other 2 had relapse.
In addition, you cannot underestimate the power of VX to clear wild-type virus very fast, well within 4 weeks. There's every chance that if you had been on the triple therapy you would have cleared and stayed that way. We both just drew the short straw on the trial, that's all. So don't be downhearted about this outcome but wait and see the next Vertex trial data. They will get this right, and your ordeal will come to an end.
dointime
Of course we all hoped things would work out differently, but as you suggest, because the trial had such early built-in stop rules, you were spared the lion's share of the treatment drugs. Hopefully, five weeks on Peg (and without riba) will not leave much of a wake. If I remember correctly, you're still stage 2, so time is still on your side regarding newer treatment protocols, including those down the road that may not include interferon.
All the best,
-- Jim
All the best,
-- Jim
I won't know if I did or didn't get to UND before the breakthrough, until the Prove 3, for me, is unblinded at week 26, which for me means another 6 mon. I already have resistant to Interferon and Riba though, so since I've treated w/o ever clearing the virus, 7 times, the Prove 3 trial was my 8th try at clearing. It's kind of like, oh well, I guess I just have something else to be resistant on.... I don't know how else to look at it. Getting upset about it doesn't change what it is, so that's not an option. Pretending that it doesn't exist doesn't work either. So, I just keep on trying new things as I get around to that point of trying again. Between my last 2 treatments, I had a 11 mon. period of time that I wasn't treating. I can say that I probably had about 2 mon. of that period of time that I actually felt half way decent. The first 9 mon. of it, I was suffering from post treatment itching, muscle pain, etc. I'm hoping that my post treatment experience this go-around won't be so bad since I didn't have the Riba AND I only was on the trial for 5 weeks (when they stopped me based on my 4 week blood results). Of course, it would have been better to have stayed on it longer because then, I might have cleared, but it didn't go that way so.... I am hesitant to try to do any more trials because there's no wiggle room there if somebody is starting to respond, but doesn't do it by their time schedule of a rigid 4 weeks. If I ever do respond, it will more than likely be outwards toward a 12 week mark, is what I think. I think that I'd be better off waiting until these things are through the approval process and all the dosage kinks are worked out and I can be on whatever meds they are, just through regular Dr.'s/prescription management. Of course, I may have that option taken out of my hands if my liver doesn't hold up, but I'm trying not to think that way.
Susan
Susan
Susan, I am so sorry to hear this news. I was in a VX no-riba arm too, went UND at day 15 and had breakthrough by day 28.
Did you ever get to UND at any point before the breakthrough? If so then you'd be left with a much reduced quasispecies pool of VX-resistant variants only. This is good because this subset might not be resistant to riba or interferon, meaning that you would have a good chance on the triple therapy.
They'll figure this thing out. In the meantime all the best,
dointime
Did you ever get to UND at any point before the breakthrough? If so then you'd be left with a much reduced quasispecies pool of VX-resistant variants only. This is good because this subset might not be resistant to riba or interferon, meaning that you would have a good chance on the triple therapy.
They'll figure this thing out. In the meantime all the best,
dointime
Hi Susan - Not sure if you remember me - veggiedip
I have been reading a bit in here lately and was thrilled to hear that you were on the Vertex Trial - Now I read you've been dropped from it due to lack of response - I am at a loss for words...There isn't anything I , or anyone else can say that will make it all better....I just wanted to say to you - I am so sorry and that you are one of the toughest chicks on these boards...If anyone deserves to be virus free - you're at the top of the list..I pray for a cure for you, me and us all...
Beth
I have been reading a bit in here lately and was thrilled to hear that you were on the Vertex Trial - Now I read you've been dropped from it due to lack of response - I am at a loss for words...There isn't anything I , or anyone else can say that will make it all better....I just wanted to say to you - I am so sorry and that you are one of the toughest chicks on these boards...If anyone deserves to be virus free - you're at the top of the list..I pray for a cure for you, me and us all...
Beth
Susan, I know very well what you are going through and I admire your courage in dealing with this.
I too treated many times, 8, now and failed all. Perhaps the triple therapy does it for me, I hope it does it for you as well.
I followed your difficulties when you were trying to sign up for the trial and was very hopeful when you were accepted. I am sure that there will be new combination therapies for non responders that will work. Probably combinations of polymerase inhibitors and protease inhibitors.
I only hope I have a fraction of your courage if I also fail treatment. I just took my week 12 blood tests, so I am now waiting to see if I stay in the trial.
I too treated many times, 8, now and failed all. Perhaps the triple therapy does it for me, I hope it does it for you as well.
I followed your difficulties when you were trying to sign up for the trial and was very hopeful when you were accepted. I am sure that there will be new combination therapies for non responders that will work. Probably combinations of polymerase inhibitors and protease inhibitors.
I only hope I have a fraction of your courage if I also fail treatment. I just took my week 12 blood tests, so I am now waiting to see if I stay in the trial.
Fortunately, I have not had progression to cirrhosis, that's the GOOD News. I am still at Stage 2 Grade 2 Bridging Fibrosis as of about 7-8 weeks ago when I had my pre-trial biopsy. I, unfortunately, had not had any reversal on any of my biopsies. When comparing each of the biopsies to the previous biopsies (I've had 4 total), I always had either progression of fibrosis, or as in my last biopsy, no change in fibrosis. From biopsy #3 to #4, which was a 3 year space of time, no change. I see that the fact that there has not been progression to cirrhosis to be a definite positive. But, taking into consideration all the times I've treated and I've not cleared, nor had reversal of fibrosis, makes me concerned about what's going to happen with it, if I don't get a clearance over the next few years. It's doubtful at this stage in the game that my body would just 'spontaneous clear' the virus, as having it for 23 years. It is conceivable that I could stay in this stage for another 20 years. It's the not knowing that's a problem for me. Anyway, I'm going to try not to dwell on it.
Susan
Susan
Susan I am so sorry to hear this, it just sounds like this horrible disease and it's treatment has taken it's toll on you. Maybe you can "just take time for yourself" in NC when you get to go. You didn't say your stage and grade... Just curious if the various treatments reversed some of the damages caused by the Hep? Hopefully it has.... (((((Hugs)))))) Just cause you need it
Nicki
Nicki
You and NYGirl said that same thing. I have an interferon and Riba resistance. I've done RIBA with every treatment until this one. The last time I treated before this trial, I was on 1600mg of Riba and went out to 44 weeks and yet, I still didn't clear. I have, though, been blessed to get rid of 1 of my genotypes. Now, instead of being 1A/1B, I'm just a 1A. I don't know what I'll do, if anything, in the future as far as treatments. I can't say that I'll totally rule it out down the road. At the moment, I can't even think about it. I'm just tired of itching and tired of the on treatment/off treatment rollarcoaster. I've been doing these different treatments always trying the next thing, etc., all the way back to 1997, 10 years, now. Time will tell.... I do know that I'm not going to do the alternative med, nature approach. Believe me, it's been suggested to me by various people (non-professionals) and I've even tried it a few times. But, it's not something that I can do. So, I'll probably be around Medhelp for awhile.
Susan
Susan
You know, Susan, If I were a doctor I would love to study you all by yourself. You might give some good insight into why people relapse. You have treated far more times than anyone else here. You must have some kind of interferon resistance.
Good luck
frijole
Good luck
frijole
Im new here - but just wanted to say my heart goes out to you. I read you treated 8 times - you're an amazing girl! I hope I can be half as strong as you are when it comes time to treat.
Thanks to all of you people, (my online family), you've really encouraged me with your kind words. Take care of yourselves.
Susan
Susan
What a slap in the face. I guess you win the prize for the most resistent quasispecies for hepatitis C. Honestly Susan, you pushed so hard and were successful in getting in.
I suppose you can wonder now if your success would have been greater with the threesome. When Teleprivar is actually on the market, perhaps the doctors will use it to tailor treatment for us.
I am sorry.
My best wishes to you.
Kathy
I suppose you can wonder now if your success would have been greater with the threesome. When Teleprivar is actually on the market, perhaps the doctors will use it to tailor treatment for us.
I am sorry.
My best wishes to you.
Kathy
Really, really sorry to hear this, I know you've fought longer and harder than just about anyone. I just get so irritated that they even have a non-riba arm for the prove 3 people. I can see a limited earlier trial to establish riba-less efficacy in treatment naive folks, but to subject previous non-responders/relapsers to a riba-less arm while already having a pretty good idea that it won't work *sucks*. I think the trials should be structured to get the drug crawling before running, and all this testing without riba before even establishing a track record with riba is putting the cart before the horse. Unfortunately people like you, dointime, nick, and just about anyone who didn't get riba in the mix must bear the brunt of this decision firsthand.
In the meantime try and keep your head up, more drugs are coming. Schering Plough's SCH503034 is at about the same level of development as VX950 is. They seem to be keeping a lid on it pretty good, although from what I know if it, its performance is pretty comparable to VX950. Plus the polymerase inhibitors are moving along too. I'd guess within a few years you'll probably have access to either another PI like SCH503034 and/or a polymerase inhibitor. I'd bet if you were given one or more of these drugs with interferon AND riba, you'd finally get rid of this parasite once and for all.
Take care of yourself and try and stay positive, probably hard to believe right now, but better times are ahead.
In the meantime try and keep your head up, more drugs are coming. Schering Plough's SCH503034 is at about the same level of development as VX950 is. They seem to be keeping a lid on it pretty good, although from what I know if it, its performance is pretty comparable to VX950. Plus the polymerase inhibitors are moving along too. I'd guess within a few years you'll probably have access to either another PI like SCH503034 and/or a polymerase inhibitor. I'd bet if you were given one or more of these drugs with interferon AND riba, you'd finally get rid of this parasite once and for all.
Take care of yourself and try and stay positive, probably hard to believe right now, but better times are ahead.
Hi Susan,,,Well,,,this is the last thing I wanted to hear this morning! I have watched you go through all your tx's and still bounce back,,,only to try again! I know that is what I love about you,,,,You are such a positive,,,fighter,,go getter and continue to come here and help others! You have guided and cheered on many here and I'm sure that is all part of the plan! Susan,,you know your time will be coming and you will be cured,,,that is what this wonderful faith is all about! I'll be in the background,,,waiting for that day! ((hugs)) Thanks for being here and continuing to support all of us through the years!
I hate reading this... so sorry to hear. You're strong woman... sometimes, even with my agnostic views, it enters my mind that we are all being tested... if this is in fact true, someone surely sees and knows your strength. But then, why the tests & games, I just don't understand it at all... Stay strong... Libby
Susan,
I of course have been following you closely as well knowing that the same could happen to me as I'm at the 5 th week point as well and the next step is to find out the verdic. I'm so sorry that the results were less than optimal but feel that you would be a good candidate for all 3 together as that seems to have been the best results to date.
I don't blame you at all for how you feel and think you should go and visit your family in the NC mtns. You're not from Brandenton are you? (I ask as I have family friends that are in your exact situation and go from FLto NC mtns every year as their get away retirement place... as my parents used to visit them in the 60's and that sounds so familiar and would freak if your parents were T&R). But yes, go visit and get this out of your mind for a while as it's been hard enough for you to try so hard for so long and get less than desirable results...)
Maybe the offering for normal use as a 3 way coctail will be available sooner rather than later as well. The only other solution seems to be the Consensus version and protocol which is a non pegulated version requireing a daily injection but that too can become a habit. That is what I will try next if I'm disqualified as well. Then as a final recourse is the living donor program that is very successful for many who have tried it. As you pick the donor and determine the compatibility and both donor and recipient grow to full size in only 7 to 10 days! it's truly amazing but the downside is the course of anti-rejection therapy that goes with that regime.
Susan, I will continue to pray for you and hope that you will find the course of action that will fit you best and you can finally ride yourself of this pescky little virus that plagues so many. I love the mtns of east TN and NC as I grew up there and live out west for a long time now but go and rest and breath the good air of the Smokies and let all the stress and worry and just fall away as you remember how good life can be when we're not so preoccupied with this junk.
Blessings and hope to you my friend... -hope-
I of course have been following you closely as well knowing that the same could happen to me as I'm at the 5 th week point as well and the next step is to find out the verdic. I'm so sorry that the results were less than optimal but feel that you would be a good candidate for all 3 together as that seems to have been the best results to date.
I don't blame you at all for how you feel and think you should go and visit your family in the NC mtns. You're not from Brandenton are you? (I ask as I have family friends that are in your exact situation and go from FLto NC mtns every year as their get away retirement place... as my parents used to visit them in the 60's and that sounds so familiar and would freak if your parents were T&R). But yes, go visit and get this out of your mind for a while as it's been hard enough for you to try so hard for so long and get less than desirable results...)
Maybe the offering for normal use as a 3 way coctail will be available sooner rather than later as well. The only other solution seems to be the Consensus version and protocol which is a non pegulated version requireing a daily injection but that too can become a habit. That is what I will try next if I'm disqualified as well. Then as a final recourse is the living donor program that is very successful for many who have tried it. As you pick the donor and determine the compatibility and both donor and recipient grow to full size in only 7 to 10 days! it's truly amazing but the downside is the course of anti-rejection therapy that goes with that regime.
Susan, I will continue to pray for you and hope that you will find the course of action that will fit you best and you can finally ride yourself of this pescky little virus that plagues so many. I love the mtns of east TN and NC as I grew up there and live out west for a long time now but go and rest and breath the good air of the Smokies and let all the stress and worry and just fall away as you remember how good life can be when we're not so preoccupied with this junk.
Blessings and hope to you my friend... -hope-
What I was told in the beginning was that Group C did not get offered the 'roll-over' option, because we knew from the beginning that we had the 'real deal' with the Telaprevir. I don't know if that decision will change after the 24 week unblinding stage. I was also told that all I had to have for Group C was a 1 log drop by the 4 week blood draw. All the other groups needed have a higher log drop by 4 weeks, but my study nurse said it was because they were given Ribavirin, too and Group C wasn't. I did not make it to 1 log drop because I had viral rebound at some point in the first 4 weeks.
As far as Infergen, that's not a solution for me. I've already done the Infergen thing 3 different times and it did not work for me either. I did it first was back in 1998, when it was recommended to do the 15mcg daily for one month followed by 3 times a week. That was what was the thing with it back then. So, I did that, for 6 mon. Didn't clear it. Also, at the time, I was taking Riba with it. I've done Infergen & Actimmune + Riba and didn't clear it. I've done Infergen + 1600mg daily Ribavirin and didn't not clear it.
Can anybody understand why I would feel like, (why try anymore on treatments?) I know that this is just my after treatment non-response funk/blues, whatever. I'll get over it. For now, I'm just trying to deal, cope, pray, contemplate, etc. I may be taking a trip to the N.C. mountains to visit my parents in a few weeks. I haven't been there in 3-4 years. They live up there in the summer and down here in FL in the winter. So, I have just been seeing them in the winters. But, after my system has a couple of weeks to adjust and my white cells to build back up a little, I'm hoping on a jet airliner to Carolina..... I still have a song in me.
Susan
As far as Infergen, that's not a solution for me. I've already done the Infergen thing 3 different times and it did not work for me either. I did it first was back in 1998, when it was recommended to do the 15mcg daily for one month followed by 3 times a week. That was what was the thing with it back then. So, I did that, for 6 mon. Didn't clear it. Also, at the time, I was taking Riba with it. I've done Infergen & Actimmune + Riba and didn't clear it. I've done Infergen + 1600mg daily Ribavirin and didn't not clear it.
Can anybody understand why I would feel like, (why try anymore on treatments?) I know that this is just my after treatment non-response funk/blues, whatever. I'll get over it. For now, I'm just trying to deal, cope, pray, contemplate, etc. I may be taking a trip to the N.C. mountains to visit my parents in a few weeks. I haven't been there in 3-4 years. They live up there in the summer and down here in FL in the winter. So, I have just been seeing them in the winters. But, after my system has a couple of weeks to adjust and my white cells to build back up a little, I'm hoping on a jet airliner to Carolina..... I still have a song in me.
Susan
I am sorry to hear this and I hope you will quickly find an alternative solution. I know you are in arm C; will Vertex offer you the triple therapy for 6 months that they offer the placebo group?
Did you fail the 4 week blood test? I heard they are raising the bar to a two log drop by week 4.
Did you fail the 4 week blood test? I heard they are raising the bar to a two log drop by week 4.
Even though, I did not always know it, when I've been weakess, he's been strong and when I've fallen, he's carried me. If I didn't have my faith to hold onto, then, I'd have said, 'why bother' a LONG time ago. I can believe that all things good, come from God and all things that are bad, hurting, evil things, etc., do not come from God.... I don't want to be preachy so I'll stop there.
Susan
Susan
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