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DewDiligence

12/07/06 12:46 AM

#23 RE: gofishmarko #22

>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.<

In the initial 80-patient randomization into four arms, only one of the arms (20 patients) is unblinded at 10 weeks. This is the arm whose initial treatment is VX-950+pegifn+ribavirin for only 12 weeks.

Two other PROVE-1 arms (40 patients combined) contain initial treatment with VX-950+pegifn+ribavirin for 24 weeks; these arms will be unblinded at 20 weeks, during 1Q07. (The only distinction between these two arms is how long the follow-up on SoC is for patients who are PCR-negative at both week 4 and week 20.)

The fourth arm in the initial 80-patient randomization is SoC only.

PROVE-1 will have a second randomization of 180 patients into each of the arms discussed above except the 12-week arm that is the one to report data this month.

Clear?
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DewDiligence

12/07/06 1:07 AM

#24 RE: gofishmarko #22

Summary of PROVE-1 over/under guesses
for initial 20-patients randomization:
 

Gofish Dew
PCR*-negative at 10 wks 95% 95%
SVR12** 90% 80%
SVR** 88% 70%

*TaqMan assay
**Based on original patient pool