Replies to post #108627 on Biotech Values

[DewDiligence]

I don't remember having seen SVR or ETR data for rib + DAA (wo IFN) from any trial. But perhaps I missed it?

The data VRTX is speaking of are deductive and stem from the omission of ribavirin rather than the omission of IFN. In VRTX’s PROVE-2 study (but not the PROVE-1 study), one trial arm had 80 patients who received Telaprevir + IFN without ribavirin and these patients did badly—see #msg-11248731 and #msg-28746843.

[dewophile]

I don't remember having seen SVR or ETR data for rib + DAA (wo IFN) from any trial

i don't think there is any, but i think designing trials with and without each component of SOC with DAAs is the proper trial design

[DewDiligence]

VRTX again modifies phase-2 Telaprevir+VX-222 trial, leaving no remaining trial arms that are testing only the 2-drug cocktail:

http://finance.yahoo.com/news/Vertex-Provides-Update-to-bw-461090422.html?x=0&.v=1

This change is due to inadequate viral control in the arm that tested Telaprevir with VX-222 dosed at 400mg BID; the arm that tested Telaprevir with VX-222 at 100mg BID was dropped for the same reason a few months ago (#msg-55917569).

There are three remaining arms in this trial (http://clinicaltrials.gov/ct2/show/NCT01080222 ):

• Telaprevir + VX-222 (100mg BID) + SoC
• Telaprevir + VX-222 (400mg BID) + SoC
• Telaprevir + VX-222 (400mg BID) + ribavirin

The ribavirin arm was added in November (#msg-56508419).