Idenix Pharmaceuticals (IDIX)

[gofishmarko]

SVR guesses

My WAGs :

TMA-neg at both 4 and 10 wks: 19/20 (95%)

SVR12 : 18/20 (90%) or 18 of the 19 who stopped tx. @12 wks.

SVR : 17/20 (85%) or 17 of the 19 " " "

It wouldn't surprise me to see 100% for all three figures , however , and I'd only be mildly surprised to see mediocre results. The only thing we can really go by is the earlier results which were from patients in Europe and Puerto Rico , and we also don't know if the viral loads or gen 1 subtypes will be similar in this study.

I have a pretty strong hunch that SVR12 will be essentially the same as SVR , with the loss of no more that a few percent , if any , that relapse between SVR12 and SVR , so change my SVR guess above to 17.5/20. I think the VX-950 studies may lead to a new definition of SVR.

The results in the next few months may tell us a lot about what to expect from the nonresponder studies , as well. If they get , say , 90% SVR in naive gen 1 patients , then about half of those responders are patients who would have failed to respond to SOC. You could then be pretty certain that there would be no difficulty in designing a successful trial in nonresponders. Of course , some of the nonresponder pool consists of patients who will be much more difficult to treat ( cirrhotics, multiple treatment failures , etc. ) , but overall it would still be clear , IMO , that VX-950 would add significantly to SOC results.

When do we see the results from the other arms of Prove 1 ? For some reason I thought we would get the first 20 patients from each arm at the same time.