I had not thought that it could be vaporware.
Abbie spoke about it in presentations
Presumably had to runs trials showing non-inferiority to the twice daily dosing
The efficacy difference between Harvoni and Viekira is slight.
The largest difference is
1) 2X daily dosing of Viekira vrs once daily Harvoni
2) Viekira pack requires ribavirin to cure geno 1a's (to the FDA SVR rate bar)
I placed this in #2 position, since currently ALL Viekira users are on 2X daily dosing. G-1b's prevalent in EU and Japan do not use riba.
3) pill burden (which could be a sub-set of #1 or could be considered draw back #3)
Therefore, in eliminating one of the major benefits of Harvoni over Viekira, I would think it a big deal; both become once daily.
Further, when the Merck program kicks in, Abbvie will be able to remain more competitive with them as well.
They may have 2016 locked up with ESRX, but they need to have some mojo going forward in 2017.
Being comparable to the competition will help Viekira, but presumably will also aid in the 2nd gen launch.
Once daily approval will be one aspect the Viekira will be competitive with both Gild and Merck programs, as well as other bolt on programs, like Sovaldi/Daclatasvir, Sovaldi/simeprevir, etc.
It may also mean that in the face of cost cutting pressure the price of Viekira will not have to compete due to this current inferiority compared to the competition.
