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<u>Cheat Sheet for GILD&rsquo;s Phase-3 Trials of Sovaldi+GS-5816</u>*

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DewDiligence Member Level  Monday, 07/28/14 02:20:15 PM
Re: jbog post# 175893
Post # of 226210 
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.

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