telprivar relapse

[Debbie556]

I posted this morning about my husband being told at wk 24 he had not met the req. to continue in they study or he had e RVR. We know he was non detectable at week seven and have been told up to that point that he was doing "the best in the study" all his levels that they did give to his Dr were great. Monday we went in and was told he relapsed and was only going to do the follow up. I have read all the paperwork from Vertex and do understand that they can stop the treatment for two reasons : one you have relapsed or you have no dectable level in you system and they are just monitoring you for the next 48 wks.  They also say you will remain on treatment for the full 48wks either way unless you are clean.I am not sure if his Dr just said he relapsed at this time because we did get blood work done at 7 wks and told him he was clear by the outside testing. We are getting him tested asap either way. I just don't understand because this is a double blind study and his Dr does not have the actual results....

[HCA]

Vertex might have been annoyed in that scenario,but don't think they would terminate.
The name of the game is to get as many SVR's as possible and dumping one would be a tick in the withdrawal box,so not good for them,

[copyman]

I'm in the Telaprevir study and this is how I interpret what you are saying. Even though your hubby may have been UNDE at week 7 by your own privite PCR he was not RVR at week 4 and also at 24 weeks was still detectable. The SOC protocol is to stop if still detectable at 24 weeks so this is why I think they are saying to stop.As a matter of fact I think this is the only way they will remove you from study, and of course for labs tanking. I hope I'm wrong. The only thing the study team sees is the bloodwork so they can monitor for anemia, etc. They are blinded to the VL's throughout study. The otherws have givin you some sound advice about getting your own PCR ASAP! Best of luck

PS,  since this hits close to home with me being in the Telaprevir study can you please post your hubby's stats, i.e. age, bx stage, starting VL, etc,etc. Thanks

[CoWriter]

What day exactly was Week 24?  Because it takes several days to get the results from the viral load.  So if week 24 was on Monday, then the viral load was due that day, right?  And they couldn't have had those results.  

There's one more reason that could have caused termination.  You went outside the study protocol and had a viral load test done at week 7.....and told the doctor about it.   If the doctor reported it to the drug company (which he should have), they could have chosen to end your husband's participation for protocol violation.  But they wouldn't tell him he relapsed.  They would just say he doesn't meet the criteria to continue.  

Co

[Debbie556]

sorry for the delay.. my husband is still taking this bad and he is out of town so phone conversations to keep him optomistic are really important. We should hear something from his study Dr tomorrow or Fri the latest. I am trying to keep an open mind and believe that he is fine and clean.This whole thing is just so hard to deal with and then to not have the information you need or to not have the Dr know how to read the paperwork is really hard. I do appreciate all the time and answers from everyone it really does help to be able to talk to people who understand and have the objective opinions that you find here. THANKS AGAIN TO ALL

[zazza]

That week 7 test was a smart move. That is why you can feel pretty relaxed by now. OK, SVR is too early to say, but UND at EOT seems to be within your reach.

[Debbie556]

week 7 came when we went outside the study to his own Dr and got his blood tested. It was non dectectable then