Follow up to studies done with incivek

Hi,
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).

[stormy456]

Talk to willbb, if there's data to be had, he's got it.  He seems to know absolutely everything ;)  

[Gerbils]

If he doesn't see this q I will. Thanks.

[stormy456]

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.

[Gerbils]

That is exactly what I am hoping for- follow up done on the people from the trials. I know that the others haven't been off long enough. Congrats to you and your husband! That is great news!

[working dog]

copyman knows a lot about the trials...also was in one.....billy

[micheall]

I have asked several members that have completed to post their follow-ups.But we will have to wait seeing they just finished.The others in the past have left the community.

[willbb]

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.

[willbb]

See  about the spelling  not  SVD"d      possibly SVR"d

[Gerbils]

Thank you! See? Stormy was right! And I attribute the spelling thing (for me anyway) to the meds. I swear I could spell before.

And special thanks for the interpretive data. It is a low number of people. Of course, we would all hope the results were that no one relapsed but we can see it aint so. Good to know. Thanks, again.

This of course is what we all worry about when we finish.
G

[crossroadsec]

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.
Karen :)

[Gerbils]

I with you!
G

[pooh55811]

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.

[jerialice]

me too- let me know when you find out!!!!
jerialice