Replies to post #169412 on Biotech Values

[dewophile]

GILD could definitely gain that much of an extra edge by adding a 3rd DAA - we'll see. a ph3 for the non-nuke or PI wouldnt start for another year at least so it wouldn't get to market until late 2016 or 2017

As for reading the tea leaves in advance of GILD's upcoming ph 3 data in gen-1s - did you happen to notice that GILD is going to start enrolling cirrhotics in a 12 week with rib vs 24 week w/o rib regimen:

http://www.clinicaltrials.gov/ct2/show/NCT01965535?term=sofosbuvir&rank=24

This suggests to me GILD probably thinks 12 weeks w/o rib is insufficient for these patients (something not consistent with LONESTAR but suggestive based on ELECTRON). then again they could just be planning ahead and scrap the study if the 12 week rib-free arms do ok

They are also going with 12 weeks in japan for 1b - i am surprised they wouldn't include an 8 week arm in these easier to treat patients, particularly since ABBV is looking at a similar 12 week rib-free QD combo that seems to have promise

http://www.clinicaltrials.gov/ct2/show/NCT01975675?term=sofosbuvir&rank=28

[DewDiligence]

GILD borrows a page from ABBV/ENTA in constructing a ‘Plan B’ for all-oral treatment of GT1 patients: adding a non-nuke as a third agent. Specifically, GILD just started a phase-2 trial with three choices for the addend to Sofosbuvir + Ledispavir: i) high-dose GS-9669; ii) low-dose GS-9669; and iii) ribavirin; all arms have a treatment duration of 8 weeks:

http://clinicaltrials.gov/ct2/show/NCT01984294

The trial includes 90 patients who are GT1a or Gt1b and are treatment-naïve or treatment-experienced. Results are expected in Mar 2014.