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Re: DewDiligence post# 103995

Sunday, 09/12/2010 7:02:09 PM

Sunday, September 12, 2010 7:02:09 PM

Post# of 257262
Telaprevir vs Boceprevir in First- and Second-Line Settings

[This is a repost of the table in #msg-52978824 where the Telaprevir phase-2
PROVE-3 study has been replaced by the much larger phase-3 REALIZE study.]



In the Telaprevir REALIZE study, the entries in the table below refer
to the non-null-responder subset rather than the full dataset because
the non-null-responder subgroup is the patient group that was treated
in the Boceprevir RESPOND-2 study (#msg-54316658).


SVR in best SVR in SVR iHub
Trial design Setting Acronym treatment arm control arm Delta reference

SoC ± Telaprevir 1st-line ADVANCE *75% (n=362) 44% (n=369) 31% #msg-50595752
Soc ± Boceprevir 1st-line SPRINT-2 †66% (n=366) 38% (n=366) 28% #msg-52949888

SoC ± Telaprevir 2nd-line REALIZE ‡78% (n=383) 21% (n=95) 57% #msg-54315761
Soc ± Boceprevir 2nd-line RESPOND-2 †66% (n=134) 21% (n=134) 45% #msg-52949888


* ‘12+12’ arm. (SVR in ‘8+16’ arm was 73%.)

† 48w arm with 4w lead-in on SoC alone. (SVR in 24-or-48-week
‘response-guided’ arm was 63% in SPRINT-2 and 59% in RESPOND-2.)

‡ SVR rate in non-null responders for reasons described
in the prologue of this post. (SVR rate in all patents was 65%.)

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