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