Replies to post #89523 on Biotech Values

[dewophile]

re HCV trials in non-responders

That the FDA allowed this trial to be conducted shows an impressive (and somewhat surprising) willingness by the FDA to consider novel ideas in the second-line / null-responder setting. We previously saw an example of such thinking in the FDA’s granting permission for BMY to run an all-oral phase-2 trial in which neither individual drug had previously been tested in phase-2 (#msg-44700187).

seems like the fda feels non-responders don't respond to interferon, so why give it to them. this could be a simplistic view in that interferon may still play a role (along with ribavirin) in preventing relapses in this population, even though the direct antiviral effects appear trivial. Assuming reasonable EOT responses are achieved it will be interesting to see what the relapse rate is like compared to pts on interferon-based regimens. ideally, trials should have arms that include interferon and ribavirin in combination and individually to truly assess what can and cannot be dropped from a regimen to optimize therapy. this is the path roche plans to pursue in the inform trials assuming the next stage of the study is successful and supports such a path

[iwfal]

Conatus - HCV

No patients in the trial receive interferon, and the variable between the two trial arms is not the experimental drug, CTS-1027, as one might, but rather is ribavirin. I.e. one of the two trial arms is CTS-1027 monotherapy for 24 weeks!

Odder is that the trial to which you are referring is 1027 vs 1027 plus rib despite the fact that in a different trial for the same drug they note:

a) 1027 is not an antiviral and has minimal efficacy by itself

b) 1027 is hypothesized to be a potentiator of IFN

Just kinda odd what combo's they are trying.