Replies to post #153409 on Biotech Values

[oc631]

Indeed it is less potent against GT2/3 in replicon assays I've seen (don't recall clinical data), but data from phase II of sofosbuvir/daclatasvir regimen were quite good in GT2/3

I didn't realise BMY tested this combo in GT2/GT3




Dewophile. I'm not sure which class would best supplement nuke-based therapy in GT3. My focus on the NS5A class is specific to GILD's situation as it relates to the path they have chosen in GT1. Just as ribavirin is near worthless as a monotherapy, a NS5A/nuke combo in GT3 could produce positive results.


Ideally GILD could bring the two drug combo to market next year in GT3 as planned. GILD could then follow up with a more potent three drug combo a year or so afterward. How this plays out IMO will be up to the FDA considering the SVR rates we see in GT3 naives. Unlike cancer, a modest improvement over existing SOC might not be good enough for approval in GT3. Especially when a more potent combo is being tested at the same point in time in GT1.

[mcbio]

GILD - new NS5A P1 trial

[H/t to @lomu_j on Twitter for this. If 5885 is the answer, why does GILD need to start a Phase 1 trial on this follow-on NS5A, GS-5816?]

http://clinicaltrials.gov/ct2/show/NCT01740791

[oc631]

So, I think it's quite possible that GILD's NS5A GS-5885 can produce similar results.

Two weeks ago GILD added Arm-17, and Arm-18 to this ongoing study. So testing of Sofosbuvir/GS-5885 and Sofosbuvir/5885/riba in GT2/GT3 has begun.



http://clinicaltrials.gov/ct2/show/NCT01260350?term=gs-5885&rank=10