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Safety and Efficacy of Short-Duration Treatment With GS-9857 Combined With Sofosbuvir/GS-5816 in Treatment-Naïve and DAA-Experienced Genotype 1 Patients With and Without Cirrhosis
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Reported by Jules Levin
EASL 2015 April 22-26 Vienna Austria
Edward J. Gane,1 Robert H. Hyland,2 Yin Yang,2 Evguenia S. Svarovskaia,2 Luisa M. Stamm,2 Diana M. Brainard,2 G. Mani Subramanian,2 John G. McHutchison,2 Christian Schwabe1
1Auckland Clinical Studies Ltd, Auckland, New Zealand; 2Gilead Sciences, Inc., Foster City, California, USA
Gilead Press Release extract:
Presented as a late-breaker ePoster (ePoster #LP03), a Phase 2 study of triple-combination therapy with a fixed-dose combination of SOF/GS-5816 plus GS-9857 among genotype 1 patients demonstrated sustained virologic response (SVR12) rates following six weeks of treatment of 93 percent (n=14/15) among treatment-naïve, non-cirrhotic patients, 87 percent (n=13/15) among treatment-naïve, cirrhotic patients, and 67 percent (n=20/30) among those who had failed therapy with two or more direct-acting antiviral agents (DAAs). The four-week regimen resulted in a sub-optimal SVR12 rate of 27 percent (n=4/15).
"These data support the ongoing development of GS-9857 and the potential for an all-oral, triple combination therapy containing Sovaldi, GS-5816 and GS-9857 to attempt to further reduce treatment duration for hepatitis C patients," said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer, Gilead Sciences. "We are encouraged by the six-week SVR12 rates and other data presented at EASL demonstrating this regimen's pan-genotypic potential, and have recently initiated additional Phase 2 studies to further evaluate the appropriate treatment duration of this regimen for all patients, regardless of genotype, including those who have failed prior therapy with directly acting antivirals and those with cirrhosis."
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