Gilead Sciences, Inc. (NASDAQ:GILD) confirms about Investigational and All-Oral Three-Drug Regimen of Sofosbuvir, GS-5816 and GS-9857 for Chronic Hepatitis C Print
By David Fowler   
Thursday, 23 April 2015 13:57

Gilead Sciences, Inc. (NASDAQ:GILD) has confirmed pre-clinical data as well as results from Phase 1 and Phase 2 studies which demonstrate development of an investigational all-oral as well as pan-genotypic regimen of Sovaldi. Sovaldi is the investigational NS5A inhibitor GS-5816 and GS-9857.

The data shall be disseminated at 50th Annual Meeting of European Association for Study of the Liver in Vienna, Austria. GS-9857 showed potent antiviral activity against HCV replicons along with an improved resistance profile vis-a-vis other HCV protease inhibitors in the preclinical study.

On the other hand, GS-9857 showed favourable pharmacokinetic profile from a healthy volunteer study. The information from three-day monotherapy study also showed that the inhibitor was well-tolerated besides achieving median HCV RNA reductions of over 3 log10 IU/mL for HCV patients.

ePoster, a Phase 2 study of triple-combination therapy having fixed-dose combination of SOF/GS-5816 plus GS-9857 for genotype 1 patients showed consistent virologic response rates after six weeks of treatment of 93 percent among treatment-naïve as well as non-cirrhotic patients.

Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer, Gilead Sciences, opined that the data gives strength to current development of GS-9857 as well as the potential for all-oral, triple combination therapy having Sovaldi, GS-5816 and GS-9857 to attempt reducing treatment duration for hepatitis C patients.

He added that the firm is motivated due to six-week SVR12 rates as well as rest of the data at EASL showing regimen’s pan-genotypic potential. He also talked about the newly initiated additional Phase 2 studies for taking evaluation further for proper treatment duration of the regimen for all patients no matter what their genotype is and including those having failed prior therapy.

Shares of the company are up over 1% to $105.30.

 




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