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SVR Rates from Telaprevir REALIZE Study in Second-Line HCV

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DewDiligence Member Level  Sunday, 09/12/10 05:23:35 PM
Re: steveporsche post# 103664
Post # of 228781 
SVR Rates from Telaprevir REALIZE Study in Second-Line HCV

These are the data from the PR in #msg-54152015 reformatted for readability.
The numbers in the SVR Delta column were obtained by subtracting the SVR
rate in the control arm from the SVR rate in the Telaprevir arms. (Definitions
of the patient subgroups are shown following the table.)


Prior Result SVR rate in SVR Rate in SVR
in First Line Telaprevir arms Control arm Delta

Relapsers 86% (245/286) 24% (16/68) 62%
Partial responders 57% (55/97) 15% (4/27) 42%
======================= === ========= === ======= ===
All non-null responders 78% (300/383) 21% (20/95) 57%

Null responders 31% (46/147) 5% (2/37) 26%
======================= === ========= === ======= ===
All patients 65% (346/530) 17% (22/132) 49%


DEFINITIONS

Null Responder: a person who achieved a less than a 2-log reduction in viral load at week 12 during a prior course of therapy.

Partial Responder: a person who achieved at least a 2-log reduction in viral load at week 12 during a prior course of therapy but never achieved undetectable viral load by week 24 during a prior course of therapy.

Relapser: a person who achieved undetectable viral load at the completion of at least 42 weeks of a prior course of therapy but did not achieve SVR.

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