Replies to post #205372 on Biotech Values

[lgonber]

totally agree. EOM

[ciotera]

Re: GILD HCV

I don't know.. looks pretty good to me. Commercially, what's important is that 95% SVR is achieved. The distinction between 95% or 98% is really not that meaningful. I for one, would not want to be treated 50% longer and pay 50% more to go from 95% to 98%. What's really important is that there was no adverse safety signal. They are still talking about this regimen as "salvage" but I just don't see why a regimen like this would not be positioned as the go-to regimen for everyone (8w for DAA naive, 12w for DAA experienced). Otherwise, they are making themselves vulnerable to an 8w regimen from a competitor that could also hit 95% SVR. So, my take on this is that SOF/VEL/VOX delivered good enough efficacy to become the new SoC and Gilead would be stupid not to position it that way.

[DewDiligence]

GILD submits NDA for SOF/VEL/VOX HCV regimen as salvage therapy for patients who failed DAA regimens including an NS5A inhibitor:

http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=2228502

The specified duration of treatment is 12 weeks for all genotypes (with or without cirrhosis), so my commentary at the bottom of #msg-125928919 appears to have been accurate.

SOF/VEL/VOX consists of 400mg Sovaldi (nuke), 100mg Velpatasvir (NS5A), and 100mg Voxilaprevir (PI; f/k/a GS-9857), co-formulated as a single daily pill.