Vertex rollover prove 3

I was dropped from the prove 3 study a few weeks ago due to not meeting driteria at week 12.

I recently found I was in the placebo group.
Will the rollover therapy be 12 week triple therapy (SOC+VX-950) followed by 12 week double (SOC)?
Or will it be 24 weeks SOC+VX-950?

I am hoping it is the latter.

Cheese.

[Andiamo1]

My study coordinator said it was the latter.

[Susie2007]

I understand it is the later also. Good luck.

[Cheesegrater]

Thank you for the info. I suppose I'll find out more when I get called in.

Cheese

[Willy50]

This is a hot topic for me.

What happens after one fails a treatment arm and rolls into another treatment?

Are they rolling into another "trial" which needs to have information sheilded from the participant?  Will they be given results of tests as they occur?
Will they be allowed the use of rescue drugs?
What is the optimal time to restart a new treatment?  (this could be based on regaining low RBC/WBC etc, is there a time period where the resistant varients may "reset to default", or other reasons to start quickly or wait longer before restarting a new treatment)

I can understand the point of keeping people blinded during a trial.  In this case however people have toed the line and complied with all the strictures of the trial.  Can they now please be allowed a treatment.....the BEST treatment that can be provided?

They have paid their dues.  REPAY them with the best chance at clearing that can be provided them.

Just my humble opinion.  If there are reasons why my thinking is addled here please let me know why or where.

best,
Willy

[scratchinghead]

Maybe this community should start a union that won't sign up for a trial unless guaranteed repayment with best chance. no?
"Lab Rats 24/48"

[Willy50]

For me....... getting into a triple therapy arm IS THE BEST possibility.  Is there any way that Vertex can make it better for the people who have already taken some risk, complied with the trial, in some cases simply retreated with SOC when it is a given that the re-treatment chances of success could be in the single digits?  

A Telaprevir treatment arm is GREAT.  I just want for these lab rats the GREATEST treatment possibility.  What is the point of not allowing them access to rescue drugs at this point?  Why not unblind their treatment?  Can they be allowed some of their medical records as they go?

I simply don't know what Vertex will allow and what the roll over treatment will look like when it comes down to the day to day nitty-gritty.  I'm not intending to complain in advance of knowing what they will offer.  Lets cross our fingers that it is a great option.  I have high hopes for the Prove 3's and also hope that those who were on SOC/placebo will roll into a even better treatment.

best,
Willy

[Cheesegrater]

I am getting different versions of what the roll over study length of telaprevir treatment is.

Those who responded to the posting here say it will be 24 weeks triple therapy. Those who are planning to have me enroll in the roll over state it is 12 weeks triple, 12 weeks SOC.

Are there any others here that have started the roll-over and can answer my original question in this thread?

Cheese

[glucklich]

I would carefully consider all the information available here in this forum if you were not a 2 log drop by week 2