Replies to post #103995 on Biotech Values

[Shengli]

Null responders 31%

There is a large piece of the pie in the general population that are non responders . This is where Merck's AASLD data will be critical .

I bet they beat this number easily

[DewDiligence]

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PROVE-3 study has been replaced by the much larger phase-3 REALIZE study.]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%.)

[genisi]

On null responder definition - there's more acceptance and I think it will grow, for the “early null responder” who is characterized by <1 log drop in HCV RNA levels at week 4 according to data from the IDEAL study.