Daklinza daclatasvir: Phase III data

The open-label, U.S. Phase III ALLY-1 trial in 113 patients with HCV infection of any genotype and with advanced cirrhosis or post-liver transplant recurrence of HCV showed that once-daily 60 mg Daklinza daclatasvir and 400 mg Sovaldi sofosbuvir plus ribavirin for 12 weeks led to an SVR 12 weeks after the end of treatment, the primary endpoint, in 83% of patients with advanced cirrhosis (n=60) and in 94% of post-liver transplant patients with HCV recurrence (n=53) and. In patients with HCV genotype 1 infection, the SVR12 rate was 82% in patients with advanced cirrhosis and 95% in post-liver transplant patients with HCV recurrence. Additionally, 97% of post-liver transplant patients with HCV genotype 1a infection and 91% of post-liver transplant patients with HCV genotype 3 infection achieved an SVR12. Furthermore, 56% of patients with decompensated cirrhosis Child-Pugh class C (n=16) achieved an SVR12.

Four advanced cirrhotic patients received a liver transplant during treatment and all 4 achieved an SVR12. One patient discontinued treatment after 31 days due to headache but still achieved an SVR12. There were 9 relapses post-treatment in the cirrhosis cohort and 1 patient had detectable HCV RNA levels at the end of treatment. There were no on-treatment virologic breakthroughs. There were 3 relapses in the post-transplantation cohort. All 12 patients who relapsed are being treated with Daklinza and Sovaldi plus ribavirin for 24 weeks. Data were presented at the European Association for the Study of the Liver meeting in Vienna. ...