Biotech Values

[DewDiligence]

New Quiz re Telaprevir Trial Designs in the Second-Line Setting

In the completed phase-2b PROVE-3 trial, patients were grouped for data-reporting purposes according to whether they were a) non-responders; b) viral breakthroughs; or c) relapsers. The definitions of these categories are given in #msg-37316151:

• Non-responders are patients who never achieved undetectable HCV RNA during or at the end of prior therapy.

• Viral breakthroughs are patients who had undetectable HCV RNA at some point during prior treatment, but had detectable HCV RNA at the end of prior treatment.

• Relapsers are patients who achieved undetectable HCV RNA at the end of prior treatment, but relapsed during follow-up.

In the phase-3 REALIZE study in progress, patients are stratified according to a different set of subgroups: a) null responders; b) partial responders; and c) relapsers. The definitions of these categories are given in #msg-32901932:

• Null responders are patients who achieved a <2-log reduction in HCV RNA at week 12 of prior therapy;

• Partial responders are patients who achieved at least a 2-log reduction in HCV RNA at week 12, but never achieved undetectable HCV RNA during prior therapy; and

• Relapsers are defined in essentially the way as in the phase-2b trial above. (For the purposes of this quiz, the relapsers category may be considered unchanged from phase-2b to phase-3.)


Q: Why is the phase-3 Telaprevir trial in the second-line
setting using a different set of categories than the phase-2b
trial in the second-line setting?