Replies to post #101433 on Biotech Values

[DewDiligence]

Re: Duration of follow-up for 24w-vs-48w HCV regimens

…another possible explanation, should the [SVR] data [from the ILLUMINATE study] be real (i.e. not statistical noise ) is that it just takes a finite amount of time for hcv to break through. I don't put large credence on this argument but it would explain both the strange SVR AND strange relapse rates. In other words, SVR24 wouldn't be an adequate measure if treatment was only 6 months.

Evidently, no one at VRTX—or the FDA—considers this a credible thesis. If they had thought a longer follow-up period than 24 weeks was warranted, it would have been trivial to design the ILLUMINATE study to follow patients in the 24-week arm for 48 weeks post-treatment (i.e. 72 weeks in all). Doing this would not even have retarded the completion of the trial because patients in the 48-week arm were already being followed for 72 weeks.