Prove 3 unblinded today

[Andiamo1]

I just had a call from the center saying that the trial was unblinded and I was in the 24triple + 24double  week arm.  I would have to be dead not to have known that, but I am curious what took so long.

Could the last participant have completed recently?  Any prove 3 people out there that just completed?

[Willy50]

I think it means that any and all information regarding it is considered open to the public and freely able to reveal, discuss, post without stepping on either your own personal agreement which covers disclosure, any disclosure by Vertex which was earlier forbidden by the FDA and could be considered "unblinding" or any disclosure by the FDA.

I think it means that any of the data is now public and no one is operating under most considerations imposed by the trial.  

As you mentioned; at this point a moot point for most concerned.  Just my take on it.

Willy

[newleaf09]

How long since you finished?  I'm also wondering how the unblinding relates to when they started (the first finishers) and when the last patient finished.  Guess it refers to "all data now in" and has nothing to do with the numbers crunching which is yet to come.

[Andiamo1]

Thanks Willy,  I already knew the rules for unblinding, but I am puzzled about the timing of it.  I was one of the first to complete 48 weeks, but I never thought people were this far behind me.

[Andiamo1]

I think you are correct.  

I completed treatment a year ago March and I thought most people started a couple of Months after me.  I am surprised it took this long.

[newleaf09]

I guess I remember from the informed consent that they'd eventually let me know about the unblinding.  What I'd REALLY like to see is early results, and maybe even results from my site.  I don't really know any of the other patients, just curious.  I guess we'll need to wait for liver meeting presentations.  Could take forever!

[Andiamo1]

What trial are you in?

Some of the Prove 3 Vertex trial data was posted at the last liver conference.  The results with prior relapsers was spectacular.  I am hopeful that they will get fast FDA approval for prior treatment failures, before we wait forever for full approval.

[newleaf09]

Boceprevir naive.  4 arms and I lucked into the 28 (4 wk SOC primer with 24 wk. PI and SOC).  We did not know the arm we got randomized into until we showed up for the 28 wk. visit and they said you won't be taking this stuff home with you.

So you think I'll see pieces of the data in print before the main report is put together?

[Isobella]

Unbelievable...triple therapy for 24 weeks.  Tough tx.

Big reward though!  

Wonder if we will see any new info coming out soon.  

[Andiamo1]

Most companies try and get good news out as soon as they can.  Since Boceprevir news is almost always good, I assume they will push as much data out to the public as the can.  It's good for the stock price!

I knew I had the real drug for the full 24 weeks; I NEVER felt that sick before during all the other times I treated.  I instantly felt better at week 24 + 2 days.

[newleaf09]

Boceprevir crashes neuts (like interferon) and hgb (like riba).  Probably shouldn't write this, but I don't know how anyone could avoid feeling worse on the triple.

I have seen the press releases on the stock info sites but can't remember if they were connected to liver meetings.  Think they were BUT I know there's a big meeting in early Nov. and a couple of big ones in the spring, plus a couple more that I just haven't noticed.  Fingers crossed for your trial info in November.   I guess the more recent trial is aimed at verifying reduced TX time for PI responders.  It will all be interesting, can't wait.