Change to Prove 2 protocol?

Did Vertex change the protocol for the Prove trials to make you stop VX-950 if you did not get RVR?  That doesn't make any sense. I did Prove 1 and don't understand why they would make anybody stop so soon. The side effects weren't that bad.  Anybody else here this?

[Andiamo1]

They have changed the protocol for prove 3 to include two checkpoints; one at week 4 and the other at week 12.  The viral loads they are looking for is something of a mystery to me.  I have heard 1 log drop at week 4 and two log at week 12 and I recently heard two log at week 4 and undetectable at week 12.  I am not sure which is the case.

Prove 3 is for relapsers and non responders, so there is good reason not to make us suffer through 48 weeks of placebo when there is no chance of SVR.  In addition, there is enough data available now to predict a positive response based on the viral load at week 4 and 12.  I think Vertex is trying to make it easier on us if the prognosis as poor.

[FullOfHope77]

That's my understanding as well but this is 'grandfathered' as well... if you came in under the 2 log drop agreement then that remains to be the case is what I was told but the change is for those just starting in this phase now. I can't confirm the change you've indicated but know that there is a change but my understanding that a new concent will accompany these changes as well.

If it's as good as indicated then 12 should be plenty of time to clear as Phase III is designed primarily for protocol (12 with all 3 and 12 with just 2 dropping the VX) for the new go forward tx strategy.

I agree on not continuing if we're not responding as the Consensus protocol may be the better route (a bit tougher) for those that are not responding to 12 weeks with all 3 drugs. And agree that likely it may be Vertex 'having mercy' on those that are not going to respond to stop earlier than later. But I sure hope that I get to continue after my 4 weeks (done in the 6th week) but understand also that a new blood test has been added to 6 week point to finalize a decision if one is 'close'.

[napli1]

This doesn't make sense to me.  I thought the literature said that if you don't get a two-log drop by Week 12 (and EVR), then there's no use in continuing on SOC.  Is VX now thinking that if we don't show RVR when TPV is added, then it won't do any good to stay on it?  Really, what's the difference to stay on it for a couple more weeks?  This bothers me a little because if they now think they have safety issues and don't want to have us on it for longer than absolutely necessary, then I want to know. And why did they make this change just to Prove 3. It's still early enough to change Prove 2, isn't it?

I'm a little nervous now.

[Andiamo1]

Prove 3 is for non responders and relapsers.  We have already proven that we do not respond well to standard treatment, so Vertex is trying to prevent us from having to go through 48 weeks of treatment when their is proof that we will not achieve RVR.

I don't think safety is part of this issue.

[napli1]

Hi Andiamo,

Thanks for that. I think it's great that they are being sensitive to limiting your exposure to TPV in Prove 3 if it doesn't look like you're going to respond. It just surprised me that they would back it all the way up to making the decision at Week 4 and not Week 12.

I see your posts elsewhere on these boards.  Hope you're doing well and get to SVR!