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Were you actually offered the choice at week 12 to switch to SOC, seeing that you cleared late into the 12 weeks? Or did Vertex make the decision to stop your tx at week 12 anyway?
I too have little doubt that with another 6 months SOC you would have been SVR.
Wishing you all the best,
dointime.
May I be so bold as to ask if you like the new Dr. Who? I only say that because Dr. Who is so obviously a wonderful concoction that could only come from the BI, but I love him all the same. We do not have the same sense of humor here, unfortunately. And speaking of that, are you a "Red Dwarf" fan? I miss it all.
I need some help from people in my same situation. You guys!?
My decision has to be made quick becuase of a study going on, and lack of good insurance, mine covers.... not much. My Dr. at Shands University, Gainesville, Fl. is quite 'happy' with type 2b (as I am) and that I can be 'cured'. This study is with the bi -weekly shots of the pending drug Albumin Interferon Alfa 2-B, with lower dose of Ribavirin. On approval ( of me in thier trial. I will pass, otherwise healthy, don't do drugs, alcohol, etc.) they call and I get put in either the test drug plan or the standard of Peginterferon w/ Ribivirin. Have any of you done the 'trial' drug? Know anything about it? I really don't want to be a guinea pig here! This drug is in final testing stage. I am told it is just as, or more, successful than the other, tolerated better and as safe?? I need to add that I have TOTAL 'drug phobia' for years, can barely take a pill so this will be hard! My sister is in her 7 year of chemo (yes 7th!) with 'chronic' cancer so I will use her for my strength/phobia, as in 'quit whining!')
Also, do you feel 1st shot, as in right away. Quit scared here, while also quite happy I am lucky enough to be type 2 instead of type 1.
Any help/ knoweldge shared is greatly appreciated and God Bless all of you in your treatments and health. Thanks, Lauri
dointime
Susan400, dointine (I think), you and othershere have experienced a viral break-though during the Vertex trials. Correct me if I'm wong but all of you were not given Ribavirin, right?
Because of my research here & elsewhere, I made a fundamental decisiion going into the Prove 3 trial.....If no Ribavin, I'm quitting the study Day 1, period.
Unfortunately we are all learnig from the Prove 1, 2 and now 3 data of what seems to be working, what isn't; new symptoms like the rash from hell and strategies to battle it.
I'm truely sorry that this tx did not work out for you and how dissppointed you must feel. My first tx I had a viral break-through at Week 32 and took the news pretty hard. I suffered and struggled or 32 weeks to end up with the same problem. It took me a while to get past it and I was pretty bitter.
Actually we are riding on the backs of the people who first tested INF, then Peg-INF, then RBV and now Prove 1, 2 and 3 clinical trials.
Thanks.
Mike
Miked, I think you've hit the nail on the head re the ribavarin. And you're right about the people who went before us. It is "reconnaisance by battle". I got off light in that I only did 12 weeks and, of course, the infuriating paradox - no riba so less to recover from. The more I soberly analyse it the more I learn from it. But in the immediate aftermath it was a different story - i was consumed with rage and despair and desperately wanted to blame somebody. The usual demons of pride and self-pity came zooming in. But I kept sharing all that as honestly as I could with people I trusted and the pain and disappointment diminished. Although I seldom post now I still follow the progress of yourself and others ( some who I know from my trial) and its a real buzz beginning to sense that intoxicating "smell of victory" . Best wishes, nick m
Its cold comfort now, but if telapravir pans out and becomes generally available in 2009 or so, I suspect you will be at the head of the queue for another joust with the dragon, eh?
Susan
dointime.
If you don't mind my asking, what do you mean? Hopefully you didn't recently score one of the dreaded "29's" or an outright quantifiable VL recently?? Whatever's going on, hang in there. Keeping fingers crossed for you.
dointime
Susan
If it does turn out to be a true rebound, try and look on the bright side in that you get to stop now instead of grinding on to the bitter end, only to relapse after a full course. You have enough liver left to last for years and years until a better mix of drugs comes along. Plus I don't think you're going to have to wait years and years to access them either. Also, I know you're worried about PI resistant strains that were bred as a consequence of no ribavirin during the early phase of treatment. Here's my two cents on that: It's true that those who take a PI as a monotherapy end up very quickly with PI resistant strains (usually within 2 weeks or so). And it certainly appears true at this point that most of those that take IFN+Telaprevir end up in a similar boat, with the exception that IFN tends to significantly depress/subdue/delay an outright full rebound to baseline VL levels (which is what happens during PI monotherapy after just a few weeks). But what's also true is that after all drugs are stopped, the virus will no longer be selectively bred. The PI resistant strains will no longer have an advantage over all the non-PI resistant strains and they will no longer selectively survive. Considering (1) how fast the virus replicates and (2) how rapidly it can mutate away from a parent virus, the resistant strains can end up being replaced predominately with "wild types" pretty quickly. And most wild types aren't PI or IFN resistant. On the other hand, the viral population will probably retain some vestige of the PI resistant species. The PI resistant strains may no longer dominate the overall population (as they did during drug therapy), but some small number of them will persist in some manner, shape or form, probably long after stopping the drugs. The viral populace will retain a certain memory of those strains - those warehoused remnants would be there as breeding stock in the event another PI assault was experienced.
But that doesn't mean that another attempt at treatment using either Telaprevir or another PI along with IFN and riba down the road won't be successful at all. The reason I say that is because Telaprevir will still kill off an awful lot of the viral population after the virus has recentered its population back to wild type (away from the PI resistant type). Plus this time around, you'll be getting a full course of IFN AND riba right off the bat (i.e. during the most critical part of treatment). You can even increase your dose of riba and/or IFN above normal levels initially to really kick it in the pants from the get go (with procrit and neupogen as your friends). The relatively small number of PI resistant "memory" viruses will still be there waiting to flex their muscles as they did before, but this time they'll have to contend with both IFN and riba simultaneously (unlike what happened before). And they're not resistant to those drugs, so there's every reason to be optimistic that they'll go the way of the dodo bird right along with the rest of their non-PI resistant friends. There's plenty of people who failed SOC treatment once and then later went on to succeed on their second shot around. So it shouldn't be hard to believe that you can do it too, especially considering that you didn't even really fail a true attempt at SOC. The peculiarities of this trial (and the lack of riba early on) is likely what jinxed your later SOC performance (assuming you truly have rebounded, which we don't know yet).
Lastly, although protease inhibitors have similar modes of efficacy, there are different proteases to inhibit. The various PI drugs being developed are not the same and just because you may now be partially resistant to one, that most certainly does not mean that you won't perform stupendously with another (provided it's dosed with IFN+riba, of course). And as previously discussed, I haven't seen any red flags popping up on SCH503034. I don't think it's quite as sexy as Telaprevir, and hasn't been getting too much publicity, but I wouldn't underestimate what it might flower into. Plus its developmental cycle is concurrent with Telaprevir, it may be commercially available around the same time (i.e. within a few years). So there's lots of reasons to be optimistic, even in the face of such a crushing blow after all you've been through (and continue to go through). Probably doesn't help much right now, but it's important to think ahead and keep your spirits up. Whatever happens, always know you can beat this thing. You're a smart person and you've gotten yourself a first class education going through this friggin' trial. If there's one thing I've learned, it's that educated and proactive patients who actively work with their doctors before and during their treatment are the one's most likely to eventually get their SVR's. You're one of those people now - I'm willing to bet big that next time will be the charm.
And you mre, you just have the knack of putting your finger on the one and only question that really matters, in this case - do I have any hope for the future, or will this effing virus just take my life, slowly and horribly?
I've noted all that you wrote and really appreciate it. I'll be questioning the doc when I go for my result. He uses protease inhibitors for HIV so he may have some knowledge about resistance, which I will ofcourse post if I learn anything.
I'll let you know when the final verdict is in.
dointime.
sounds like you are considering the same trial i have doing since March. Of the 14 people in my trial group all have been UNDETECTABLE at 12 weeks which is a pretty amazing stat.
I have about 6 months to go and this will undoubtedly be the longest year of my life. The side effects are definitely no fun . ( anemia=low energy, riba rash, riba cough, most food tastes lousy; these are currently the most prevalent) However i would say the reward of possible obtaining SVR and beating this freaking virus clearly outweighs the risk and inconvenience of 48 weeks of treatment.
Don't worry about feeling like a guinea pig. The clinical nurses are very good and provide good care. Plus you only have to inject Albumin Interferon every 2 weeks instead of weekly, a definite plus.
Best wishes and take a kick *** proactive approach towards wiping out the virus. I had it for many years unknowingly and am Stage 4 Grade 3 Liver Damage ( not good) but I am taking revenge on these viral bastards.
Big Al
I think I am in a similar boat, I feel like someone just died. I am going through all the stages of grief-especially anger. I am 29-got hep c at birth and have been on every trial and medication so far (4 different attempts, even back when it was daily injections). I just ended the stage 3 trials and feel like knocking out my doctor who convinced me against my better judgement to continue with the trial even after finding out I wouldn't be getting Ribo. Only one other person in the group is out of the study...they were also not getting the Ribo. I feel a bit robbed of my chances and as if I continue to be a test for things they already know. (I was in the original trials to prove the combo was better) I am losing the optimism and faith. Help!!!!!!
Susan
I don't know if these thoughts will help you but they are all that I have which help me right now.
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Don't think too much about the really big issues until you are out from under the cloud of the meds. Ofcourse you can't help it, but try to change the channel when you are dwelling on dark thoughts and remember that it will all look less gloomy once you have shaken off those horrible neurotoxic meds.
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Start thinking about looking after yourself and how to live well with HCV and preserve your liver health. We know we have the virus and we are on the clock, so it is all about staying healthy long enough for meds to arrive which will work for us. You asked about the new meds. I am watching the progress on anti-fibrotics (eg. Pancaspase Inhibitor PF-03491390). I would not be too concerned about living with HCV if these drugs could prevent the liver damage.
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I am not a quitter and I can tell from your story that you are not either. But there's no point in just spinning your wheels. You don't say what state your liver is in but I hope you have time to take a break, regroup and live a little. That's what I am planning to do when I finally can pick myself up off the floor. I'll let others do the trials from now on and watch the progress from the sidelines. When something that works gets on to the streets I'll have another go.
Out of all this mess I think you can still believe in one thing - yourself.
All the best,
dointime.
In a nutshell, what I said to dointime above applies to you too if you didn't get the riba. And like I said there are other drugs being developed like SCH503034 which you might be able get access to in a similar timeframe as Teleprevir when it is approved (assuming it gets approved). Here's what I would probably do if my liver had significant fibrosis (F2-F3):
1. Wait until you had a clean shot at accessing some type of PI, be it telaprevir or preferably one of another type like SCH503034. This will probably happen within 3 years or so. And by "clean shot" I mean access to it without any strings attached - NO blinded groups, NO blinded PCR's, NO denial of ribavirin or interferon, NO imposition of only "standard" interferon/ribavirin dosage, NO limitations on treatment duration, and NO denial of rescue drugs.
2. Then I would get with a talented and renowned hepatologist. If you have to drive a good way to see one, then so be it. You want a real pro who knows how to custom tailor an aggressive course of treatment for you. Someone who understands the importance of maintaining full dosage and the use of rescue drugs. Don't settle for any Dr Stanley Standard outta the yellow pages, get yourself a pro.
3. Discuss with your doctor the possibility of getting some neupogen and procrit prior to starting your treatment. Have it on hand in your fridge before you start. Discuss with your doctor about doubling up on IFN dose for at least the first 1-3 months of treatment, and/or exceeding your standard weight based dose of ribavirin (to whatever level you and him think is advisable). Bottomline is that you want to get more of those nasty drugs into your system during the critical early phase of treatment, make sure he's on board and you're on board (assuming you're sufficiently motivated to take this risk). Also discuss the possibility of treating longer than 48 weeks if your performance during treatment dictates that. Make sure yor doctor is on board with that.
4. Make sure your doctor will allow you to be PCR tested at frequent intervals AND that a sensitive PCR test is used (<10 IU/ml minimum). Ideally I would want to be tested weekly until I became UND. And then maybe bi-weekly and then once every 4-6 weeks after that. You want to know when you become UND and that you stay UND - it's an important piece of information when deciding when/if to back off on the elevated drug dosage and ultimately when to stop treatment. Also have your regular bloodwork checked more frequently too, especially considering the elevated risk of severe anemia and neutropenia that comes with high doses of IFN and riba.
5. Make sure your doctor is ok with pre-emptively dosing procrit as soon as you start taking the high dose ribavirin. Procrit has a lag time of about 2 weeks before it kicks in, you don't want to have your HGB drop under 10 right off the bat causing you to crash and burn right out of the gates. Examine your response to ribavirin in your earlier courses of treatment (from your labwork, get copies if you dont have them) to get an idea of high quickly your hemoglobin drops off; this can help interpolate how much procrit may be appropriate before your HGB actually drops to undesirable levels. Neupogen is fast acting, so you shouldn't need to take anticipatory doses of that drug, but you do want it handy if and when your neutrophils (ANC's) tank.
6. If you know of any peculiar vulnerability you have to the drugs, then use that knowledge to custom tailor your elevated dose plan. For instance, if your skin is especially sensitive to ribavirin and/or your HGB really plunges in response to it, then go easy on ramping up riba too high. If you have a real problem keeping your neutrophils above, say 500, during a normal course of treatment, then consider going easy on the double dosing of IFN. Also, if you have sensitive skin and a lot of dermatologic problems, hook up with a really good dermatologist before starting treatment (preferably one that has experience with hep C patients). Discuss what you're going to do and have him/her on your team from the git' go. Also look into getting on some A/D's before starting treatment (if you think you might need one), and find one that works for you. The only way to find one that might work for you is by trial and error, which can takes months and months or even over a year. So start early on that one and try and find one that will help you through what will almost certainly be a tough fight.
Anyway, that's about it for starters. You just gotta keep on keepin' on. You can beat this thing, in fact you probably would have beat it if you had been allowed to take ribavirin. It totally sucks that your a-hole doctor kept you going without it, but the bottomline is that you're a young guy with resilience to spare. Next time make sure YOU'RE in the driver's seat and yhave a plan to WIN! Good luck...
http://youtube.com/watch?v=rCCJ8n3RgzQ