Sovaldi and GS 5885 combo meets primary endpoint in Phase III HCV study - Gilead Sciences

Gilead Sciences has announced topline results from a Phase III clinical trial (GS-US-337-0113) in Japan evaluating the once-daily fixed-dose combination of GS 5885 (ledipasvir) (LDV) 90 mg and Sovaldi (sofosbuvir) (SOF) 400 mg, with and without ribavirin (RBV), for the treatment of genotype 1 chronic Hepatitis C virus (HCV) infection. Among patients receiving 12 weeks of LDV/SOF without RBV, 100 percent (n=83/83) of treatment-na�ve and 100 percent (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-na�ve and 100 percent of treatment-experienced patients (n=87/87) achieved SVR12.

Across all arms of the study, patients with cirrhosis achieved a 99 percent (n=75/76) SVR12. The study met its primary endpoint of superiority compared to a predefined historical SVR12 rate. Patients who achieve SVR12 are considered cured of HCV infection. Adverse events observed with LDV/SOF without RBV were generally mild and included nasopharyngitis (28 percent), headache (6 percent) and malaise (5 percent). Based on these data, Gilead plans to submit a New Drug Application for the LDV/SOF fixed-dose combination with the Japanese Pharmaceutical and Medical Devices Agency (PMDA) by the end of 2014. The product is currently under regulatory review in the United States and European Union.