It's not Boc or Tela, but here's a trial for relapsers:
http://www.clinicaltrials.gov/ct2/show/NCT00980330?term=tmc435&rank=1
If you did in fact have the placebo please consider going right into the rollover with the real thing. Boceprevir seems - from threads I have read - to be doing an outstanding job.
I would not flip to Telaprevir if I were you just because you will automatically roll to the Boceprevir and you might not get in a Telaprevir trial. I actually thought most of the trials wer already closed. I was not aware of any relapser trials still filling slots (which is what you would have to qualify for) but if you know of one, could you post it here. Relapser trials are hard to come by.
I hope you got the placebo.
frijole
Ooooh. So sorry to read your news. And it is so frustrating not knowing what you got. Clearing kept you from the rollover IF you were on placebo. Were you naive?
NYG: Week 6 would technically be 2 weeks of boceprevir (you complete 4 weeks of SOC lead-in and then began blue pills). Viral load test after two weeks of Bocep/placebo at week 6 of trial.
Really stressful trying to guess if you got it or not. I was still detectable after 12 weeks, but that doesn't mean that I got placebo for sure.
Speculation at my trial docs makes them think that Teleprevir will be approved before trial is unblinded. But who knows?
Also, Doc continues to say that they don't know enough to say you can't do one PI if you don't respond to another, so I think there is still a reason to believe Susan will be adding a PI that will work at some point.
Floor guy, if you were getting placebo, now that you have relapsed, you fall into a group that has a better success rate with PI's than non-responsders. So let's hope for that, if there is a silver lining in this crummy news.
Again, so sorry.
Oh Lord banarep that would be such wonderful spectacular fantastic incredible news! Then someone like Susan400 could retreat - what happened to her was so not FAIR and she deserves a shot with all the meds!
Now regarding Boce - I thought most people who had the drug went UND at like week 2? Week 6 seems like straight SOC to me, especially if you did 48 weeks and relapsed. Just a guess but I think UND that late would imply it.
Wait and find out if you got the meds or not and you will have a much more clear answer.
So sorry for your bad news......so very sorry.
By the way, my study doc here told me that they have reveresed the idea of those that fail PI treatment can not redo it. Vertex is looking at a rollover for those in my study that did not get SVR, including those that were on telapriver. I will post when I know more.
gee,,,that is so hard to take...it's completely discouraging I know...heck I can't even figure why they have a control arm at this point...they have so many stats on SOC it hardly seems human to put folks through that with the PI's right there.
It will be interesting to find out if you got the PI, or a low dose of it. Why do you have to wait so long??
In any case, unless you failed on the high dose PI, it would be well worth your while to do the rollover, After all, only in a trial can you get these drugs,, and they do increase SVR to 75% to 93% which is well above what SOC could ever do.
Most studies have a roll over option for those that got the placebo, you need to check with your study doctor. I just finished the Relaize study with telaprevir and at post 2 weeks am UND. I have heard good stuff about both.
Good luck and check with your study doctor.
Sorry to hear about the relapse, I know what a kick in the gut that is.
When you find out whether you received the placebo or the boceprevir, please let us know
sorry to hear you relapsed. i did 48 weeks in the boc trial. i am 4 months past treatment. i cleared at 6 weeks . i suspect i was on the real thing. did you have that metallic taste all the time? i did . you will be able to get the real boc if you had placebo. someone else will chime in and explain it more to you.
Wow. So sorry to hear this! I've also been on a boceprevir study for naive type 1s. Was absolutely on the real thing based on how the anemia hit and various side effects (awful taste, gastric issues, etc.) plus when I was re-randomized at week 28 that went away.
I'm also about 10 weeks off the study (last shot 11/10) and was still UND at week 4 EOT.
If you *didn't* get the real thing, I'd recommend going back and doing it with the boceprevir.