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Re: DewDiligence post# 173645

Wednesday, 04/02/2014 4:39:48 PM

Wednesday, April 02, 2014 4:39:48 PM

Post# of 257268
GILD reports Sovaldi phase-3 results in GT2 Japanese patients:

http://finance.yahoo.com/news/gilead-announces-results-phase-3-203000280.html

97 percent (n=148/153) of genotype 2 HCV-infected patients receiving 12 weeks of an all-oral regimen of sofosbuvir plus RBV achieved a sustained virologic response 12 weeks after completing therapy (SVR12). SVR12 rates among treatment-naïve and treatment-experienced patients were 98 percent (n=88/90) and 95 percent (n=60/63), respectively. Of the 153 patients who received treatment, 11 percent (n=17) had documented cirrhosis.

This regimen is a lock for Japanese approval in GT2, which is the second most common genotype in Japan. GILD is also conducting a phase-3 trial of Sovaldi + Ledipasvir ± ribavirin in Japanese GT1 patients, which is expected to report data in 2H14.

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