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Re: DewDiligence post# 76968

Thursday, 04/30/2009 5:22:47 PM

Thursday, April 30, 2009 5:22:47 PM

Post# of 257269
Quiz re NEJM Pub on Telaprevir PROVE-1/2 Data

http://finance.yahoo.com/news/New-England-Journal-of-bw-15075801.html

This PR has a table that shows the relapse rates in the “12+12” arms of PROVE-1 and PROVE-2 were 2% and 14%, respectively. A footnote says this:

The relapse rate in the 24-week telaprevir-based treatment arm of PROVE 1 reflects only those patients who achieved RVR and remained undetectable through week 20. For patients in the 24-week telaprevir-based treatment arm of PROVE 2 who achieved RVR and remained undetectable through week 12 the relapse rate was 7%.

The relapse rate in the “12+12” arm of PROVE-2 was reported in two ways: it was 7% for patients who had an RVR/EVR and was 12% for all patients in the arm. On the other hand, the relapse rate in the “12+12” arm of PROVE-1 was reported in only one way: for patients who had an RVR and had undetectable virus at week 20.

Q: Why was the relapse rate in the “12+12”arm reported differently in PROVE-1 than in PROVE-2?


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