Replies to post #180759 on Biotech Values

[DewDiligence]

Addendum (from ABBV/ENTA standpoint): Inasmuch as GILD is apparently not seeking approval for an 8-week or shorter regimen of Sovaldi + GS-5816, there is no reason for GT1 patients, specifically, to prefer Sovaldi + GS-5816 to Sovaldi + Ledipasvir.

Thus, the Sovaldi + GS-5816 regimen does not present a competitive threat to ABBV/ENTA’s 3-DAA regimen, although it figures to compete with ABBV/ENTA’s pan-genotypic 2-DAA combination of ABT-493 + ABT-530.

[STOCK_GAINER6]

The efficiacy also depends on the formulation

[caravon]

I must give a big credit to GILD’s running all these Phase-3 Trials of Sovaldi+GS-5816*.

Somehow ABBV "takes its time".

[DewDiligence]

Phase-2 data on Sovaldi + GS-5816 show why only 12w regimens were advanced to phase-3 by GILD:

http://finance.yahoo.com/news/gilead-announces-phase-2-data-130000472.html

The results…presented at the Liver Meeting this week (Oral #80), evaluated eight weeks of SOF plus GS-5816, with and without RBV, in patients with genotype 1 or 2 HCV infection. Among genotype 1 patients receiving SOF plus GS-5816 100 mg, SVR12 rates were 81 percent (n=25/31) and 90 percent (n=26/29), with and without RBV, respectively.

81-90% SVR12 isn’t good enough anymore.

In short, Sovaldi + GS-5816 will be an improvement relative to Harvoni only for GT3 patients.

See cheat sheet in #msg-104733739 for the Sovaldi + GS-5816 phase-3 program.