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Gilead Sciences Inc announces results from Phase 3 Study of Sofosbuvir Among Hepatitis C Patients in Japan

Wednesday, 2 Apr 2014 04:30pm EDT 

Gilead Sciences Inc:Topline results from Phase 3 clinical trial (Study GS-US-334-0118) in Japan evaluating once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin (RBV) for treatment of genotype 2 chronic hepatitis C virus (HCV) infection.Study met primary efficacy endpoint of superiority compared to predefined historical control sustained virologic response (SVR) rate.In study, 97 percent (n=148/153) of genotype 2 HCV-infected patients receiving 12 weeks of an all-oral regimen of sofosbuvir plus RBV achieved sustained virologic response 12 weeks after completing therapy (SVR12).SVR12 rates among treatment-na├»ve and treatment-experienced patients were 98 percent (n=88/90) and 95 percent (n=60/63), respectively.Of 153 patients who received treatment, 11 percent (n=17) had documented cirrhosis.In Study GS-US-334-0118, 153 patients (100 pct) became HCV undetectable by treatment Week 4 and remained undetectable through remainder of the 12-week treatment period.Post-treatment relapse accounted for five virologic failures.There were no treatment discontinuations due to adverse events and all patients completed the 12 week post-treatment follow-up visit.Most common side effects observed in study, consistent with population and safety profile of RBV, included nasopharyngitis, anemia, headache, malaise and pruritis.Full study results will be presented at future scientific meeting. 

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18 Dec 2014