Replies to post #175893 on Biotech Values

[DewDiligence]

GILD’s Sovaldi + GS-5816 combination is essentially equivalent to Sovaldi + Ledipasvir except that it works in genotype-3, where Ledipasvir isn’t active.

[DewDiligence]

Cheat Sheet for GILD’s Phase-3 Trials of Sovaldi+GS-5816*


• ASTRAL-1—All genotypes except GT3; Sovaldi + GS-5816 for 12w vs placebo(!) for 12w; 600 patients; expected completion Oct 2015:
http://clinicaltrials.gov/ct2/show/NCT02201940

• ASTRAL-3—GT3 only; Sovaldi + GS-5816 for 12w vs Sovaldi + ribavirin for 24w (i.e. existing GT3 “SoC”); 500 patients; expected completion Dec 2015:
http://clinicaltrials.gov/ct2/show/NCT02201953

• ASTRAL-4—All genotypes with cirrhosis; three arms: Sovaldi + GS-5816 for 12w vs Sovaldi + GS-5816 + ribavirin for 12w vs Sovaldi + GS-5816 for 24w; 225 patients; expected completion Nov 2015:
http://clinicaltrials.gov/ct2/show/NCT02201901


GILD has aparently thrown in the towel on the idea of seeking approval for 8-week or shorter regimens of Sovaldi + GS-5816.

H/t @lomu_j.

*GS-5816 is an NS5A inhibitor that has better activity against GT3 than Ledipasvir.

[caravon]

Mark Schoenebaum, a high-profile analyst for ISI and a longtime booster of Gilead's blockbuster hepatitis C efforts, gives the biotech the inside track to one of the Holy Grails in biotech: one pill that can conquer the entire global market.

But is it really necessary to have a single pill for all HCV genotypes? I am trying to say that it is nice to have a single antibiotic for all kind of bacterial infections but it always comes together with undesirable side-effects and consequences.

Furthermore, having a pill for a specific HCV genotype can potentially cut treatment time well below even 4 weeks. For a “typical” HCV patient, it will make a lot of sense.