Replies to post #163863 on Biotech Values

[oc631]

Why need to measure for efficacy for 16 and 24-weeks if 8 and 12 was sufficient from other trial with GT1 patients?

You are right Sofo/Riba will never be used in GT1 outside of this study. So why run the study? GILD is insecure about achieving GT3 labeling for Sofo/Riba so running this study looks good on the resume. Even though SVR data won't read-out until after a decision has been made by the FDA. I would love to hear other theories. When you are one of the dumb members on this board, speculation is O.K., because your reputation is intact.


I would like to hear other theories.

[jq1234]

Different combinations. To me they just simply want to see this combo in GT1 with longer treatment duration as addon to GT3 longer treatment duration for naive study they wanted to do, nothing else. In GT3, longer treatment duration 16 weeks did produce better numerical SVR in treatment experienced than 12 weeks. If they have concern with other combo currently in pivotal trials, they would have explored different combination than simple sofosbuvir plus ribavirin combo. Longer treatment duration for this combo in GT1 wouldn't tell them anything about treatment duration for other combo.