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Gilead Sciences Inc announces phase 3 data showing that fixed-dose combination of Ledipasvir/Sofosbuvir achieved 100 pct. sustained virologic response among patients with chronic hepatitis C in Japan

Sunday, 15 Jun 2014 08:00pm EDT 

Gilead Sciences Inc:Announces topline results from a Phase 3 clinical trial (GS-US-337-0113) in Japan evaluating investigational once-daily fixed-dose combination of NS5A inhibitor ledipasvir (LDV) 90 mg.And nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg, with and without ribavirin (RBV), for treatment of genotype 1 chronic hepatitis C virus (HCV) infection.Among patients receiving 12 weeks of LDV/SOF without RBV, 100 pct. (n=83/83) of treatment-naïve and 100 pct. (n=88/88) of treatment-experienced patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12).Among patients receiving LDV/SOF plus RBV, 96 percent (n=80/83) of treatment-naïve and 100 pct. of treatment-experienced patients (n=87/87) achieved SVR12.Across all arms of study, patients with cirrhosis achieved 99 pct. (n=75/76) SVR12.Study met its primary endpoint of superiority compared to a predefined historical SVR12 rate.Patients who achieve SVR12 are considered cured of HCV infection. 

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