Gilead Sciences (GILD) announces positive top-line results from a Phase 3 HCV clinical trial in Japan evaluating the investigational once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) and Sovaldi (sofosbuvir) (SOF) with and without ribavarin (RBV).
100% (88/88) of treatment-experienced and treatment-naive (83/83) patients receiving LDV/SOF without RBV achieved a sustained virologic response 12 weeks after completing therapy. 96% (80/83) of treatment-naive and 100% (87/87) of treatment-experienced patients receiving LDV/SOF plus ribavarin achieved a sustained virologic response. Across all arms of the study, 99% (75/76) of cirrhosis patients achieved a sustained virologic response.
The study met its primary endpoint of superiority compared to a predefined historical sustained virologic response rate. Patients who achieve this are considered cured of HCV infection.
HCV type 1 is the most common strain of HCV infection in Japan, comprising ~70% of the 1M chronic cases. Gilead plans to submit an NDA for the LDV/SOF fixed-dose combination with the Japanese Pharmaceutical and Medical Devices Agency by the end of 2014.