Has anyone seen any follow up on the people who participated in the incivek trials? I am wondering if they have seen any of the subject people relapse 6 months or later after completing the treatment and being UND?
I hope that was clear. I know that the drug wasn't approved for "general consumption" until May of 2011 and that most of the people who finished taking it haven't been off for 6 months yet because I am one of them (I started tx June 23rd).
I do think you're going to have to be satisfied with trial data as Incivek was only approved May 2011, so don't think there is any 6 mo. post treatment data available. FYI, my husband was UND at Day 4 of triple, still UND at 4 weeks. We're very hopeful and expecting the best.
stormy 456 ..lol thx .for that ,however not quite everything. I still can"t spell worth a damn :)
You folks are correct ..there is no one yet that has SVD"d treating outside a trial with either protease . too soon
This is from the Inci.(Advance) trial for treatment naives...
Outcome for Subjects without SVR
On-treatment virologic failure ( a ) 7%
Relapse ( b ) 4%
Other (c ) 11%
a ) On-treatment failure includes subjects who met a protocol-defined virologic stopping rule or who had detectable HCV-RNA at the time of their last dose of INCIVEK and subjects who had viral breakthrough on peginterferon alfa/ribavirin.
b) Relapse rates are calculated with a denominator of subjects with undetectable HCV-RNA at the end of treatment.
c )Other includes subjects with detectable HCV-RNA at the time of their last study drug but who did not have viral breakthrough, and subjects with a missing SVR assessment.
I find these numbers encouraging! Woohoo! So of I'm not part of the 7%, and you know some other the "other" could mean anything.. I'm gonna raise my success rate at week 27 UND to shave off maybe uh.... 10% total?
Lol. I'm going w 90% AT the very LEASTt for me! Naw. I'm going for 100% SVR. Yeah.
c ) Other includes subjects with detectable HCV-RNA at the time of their last study drug but who did not have viral breakthrough, and subjects with a missing SVR assessment.
I understand A and B but I am not sure I understand C.
What does "subjects with a detectable HCV-RNA at the time of their last study drug but who did not have viral breakthought" mean? I understand they were detectable at the time of their last study drug, but if they were detectable at that time, how can they have a viral breakthough (if they are already detectable)?
I am sure there is something I just don't understand about the terminology. I am still learning.
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