VX-950 PROVE 2 LONDON GROUP

I

[jmjm530]

If I understand you correctly, other than the no-riba group, the other difference is that Prove 2 dropped the ARM that dosed VX-950 and SOC for 12 weeks and that then continued with SOC for another 36 weeks for a total of 48 weeks. Was that arm dropped recently or has it been in the works for awhile? My unscientific feeling all along is that Vertex was designed with either a 12 or 24 week tx protocol and the 48 week Arm (Vertex plus SOC) was stuck in solely to appease the FDA or to cover their a**. I asked about the time frame, because if this arm was recently dropped, it may reflect some more complete positive preliminary post treatment SVR data that has not yet been made public.

-- Jim

[Happyhungry]

Hi Jim:
all I know was that there was no 48 week arm in the London PROVE2 trial nor in the  summary data of PROVE 1 and PROVE2 released by Vertex.  I infer that they made this call well before starting PROVE2.    

[jmjm530]

OK. No 48-week triple therapy arm in Europe as well as a no-riba arm in Europe and not in the States. One reasonable conclusion is this is what Vertex wanted all along but had to make some modifications to appease the FDA.

-- Jim

[Happyhungry]

Further thoughts.  In PROVE1 taking out the control arm,  20 out of 180 subjects (9%) were on regimes lasting only 12 weeks.  In PROVE2 taking out the control arm, 160 out of 240 subjects (66%) were on regimes lasting only 12 weeks.  Putting it another way, PROVE 1 exc. control had 160 out of 180 (89%) of subjects on regimes lasting 24 weeks or MORE while PROVE 2 excluding control had 240 out of 240  (100%) of subjects on regimes lasting 24 weeks or LESS.

Why this abrupt reduction in regime length

[jmjm530]

Of course all this is speculation, but I sure hope the emphasis on shorter treatment has something to do with the 12-week results (or other research) none of us have seen yet. While I have no doubt true that Vertex is aiming for a significantly shorter treatment period -- 12 to 24 weeks -- it seems like too much of a gamble for such a radical shift in tx protocol percentages unless they have good reason to believe it will work in 12 or 24 weeks. Let's hope it's that and not as you say Boger holding his breath and going for broke :) Please do keep us updated on all things Vertex on your side of the pond. This is very valuable information you've been imparting here.

All the best,

-- Jim

[COLUMBUSOHIO]

I am in the prove 1 clinical trial in the usa.

I am at week 26 and I am clear no detectable hcv rna.

I am in group b INF + RBV AND DID RECIVE 12 WEEKS OF VX-950.