BioCentury
ARTICLE | Clinical News

Daklinza daclatasvir: Interim Phase II data

May 4, 2015 7:00 AM UTC

Interim data from 35 patients with recurrent chronic HCV genotype 1b infection following an orthotopic liver transplantation in the 2-part, open-label, European Phase II SATURN (TMC435HPC3016) trial showed that once-daily 150 mg oral Olysio simeprevir and 60 mg oral Daklinza daclatasvir plus ribavirin led to HCV RNA levels of <25 IU/mL in 90.5% of patients at the end of treatment at week 24 in part 1 of the trial (n=21). In part 2, 92.9% of patients receiving the combination had HCV RNA levels of <25 IU/mL at week 4 (n=14). Part 1 of the trial enrolled patients with METAVIR scores of F1 or F2 and part 2 enrolled patients with METAVIR scores of F1-F4. Patients also received concomitant stable immunosuppressive therapy with cyclosporine A or tacrolimus. Data were presented at the European Association for the Study of the Liver meeting in Vienna. ...