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Protease Inhibitor Boceprevir i
Patients in any arm of the study with detectable virus at week 12 will be considered treatment failures and will discontinue treatment
sounds right to me. the PI's in study should knock the virus out in as little as a day or a week. so if still detectable at 12 weeks then the patient is a failure under PI study guidelines. telaprevir is a little different and use 24 weeks as a failure and patient is pulled then.
Hurrrumpfh, would that be the patient or the study drug that's the failure?
I hate that they call it 'patient failure' when it's the drug that has not worked for that patient, and therefore it won't work for a percentage of others and therefore they have to keep researching. I mean, we are hoping to find a CURE for HCV aren't we?
And do patients get the option to continue on with SOC in that instance? I mean we have heard of very late responders who have gone on to achieve SVR.
I hate that they call it 'patient failure' when it's the drug that has not worked for that patient, and therefore it won't work for a percentage of others and therefore they have to keep researching. I mean, we are hoping to find a CURE for HCV aren't we?
And do patients get the option to continue on with SOC in that instance? I mean we have heard of very late responders who have gone on to achieve SVR.
You have a point here...i guess a bit of both..drug and patient failure...i also hear the PI`s knock the c.rap out of the monster within hours...same ole problem tho....is keeping the beast down and out for the count...but it does a better job that SOC alone..PI`s are our biggest hope right now
Sense were in the same trial you need to have them give you a consent form. If your virus is detectable after 12 weeks of tx you will be discontinued from tx. BUT if you are discontinued from this control arm you will be able to go in the "PROVIDE" study where you will be given the boceprevir for the remainder of tx.
So you don't have to stop tx at week 12, you will just know you were in the placebo arm and then be given the real drug the remainder of tx...... Best to you
So you don't have to stop tx at week 12, you will just know you were in the placebo arm and then be given the real drug the remainder of tx...... Best to you
Yes...i knew that my man....more good news...my nurse said on Friday that i will recieve the full study reports as i go for the weekly blood PCR tests...i will know about how the BOC drugs are working in my system too...i said to her,isnt this s blind study....she says thats the way this study is set up....ANYONE else have any info on this??????????...BTW...my VL baseload at the start of this trial was 21 million....OUCH...pretty much the same as the last tx start...my LFT test are in normal range....i feel great otherwise ...just did my 3rd shot and all is well...slight headaches for 2 days...no eye pain the last 2 shots
What would be a real BUMMER would be to clear the virus before week 12 and you are in arm 1...with the fake drugs....this means you will go the full 48 weeks with candy and SOC drugs....THIS IS CRUEL
BUT i petty much know from my last tx i will not clear by week 12 if im on the candy...because last tx i was still detacable at week 12...412 copies,,,but i did clear at week 13or later....still tho...i was 25 million at base load in my first tx...thats a lot of killing...i just feel if i get the real deal this time i will have a good chance
Well, Rocker, I am unhappy to report that I've been given the official, 'NO WAY, JOSE' from Schering on ever being allowed to do the Boceprevir trials, or any other Protease Inhibitor. It's not unexpected, but discouraging none the least. There's really not much out there for me anymore as far as hope for any treatments; unless or until a polymerase inhibitor trial would ever take me. Waiting until these drugs are FDA approved is not even a hope for me as I have no prescription drug insurance. Actually, I do always have the hope that God will heal me, I won't ever give up hope in that. I do wish you the best of luck in your SVR with the Boceprevir.
Susan400
Susan400
Sorry to hear this...are you 100% sure...there has to be upcoming trials for people in your situation...did they tell you they will not be doing any future trials for,,,,can you be classified as a nul-responder?...it seems to me the the PI``s are the best shot out there ...i dont understand ...isnt saving lives the object here?...cant they make special arrangements for tough responders...?...keep on there backs i say
I sent a letter to Schering, begging them to allow me to participate in the trial and I told them that I'd sent my records out to the nearest trial site already. I was told point blank that I would not be allowed to treat in any protease inhibitor trial, Boceprevir included. I am not considered a null responder as I have had a 2 log drop on a few of the times that I treated, in the first 12 weeks, but I've never cleared. So, I'm not considered a null responder and I'm not considered a relapser, most like a partial responder/viral rebound type of thing. My white cells and red cells at the present time are fine. The only reason that they gave is the experience with being exposed to a protease inhibitor.
Susan400
Susan400
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