Daklinza daclatasvir: Phase II data

The open-label, Chinese Phase II SODAPI trial in 26 non-cirrhotic patients with chronic HCV genotype 1b infection showed that Harvoni ledipasvir/sofosbuvir plus Sunvepra asunaprevir (Group 1, n=12), Sovaldi sofosbuvir plus Daklinza daclatasvir and Olysio simeprevir (Group 2, n=6) and Sovaldi plus Daklinza and Sunvepra (Group 3, n=8) led to a rapid virologic response (RVR), defined as plasma HCV RNA levels of <500 IU/mL by day 2, in 18 patients. Specifically, an RVR was achieved in 6 patients in each group. Baseline viral load was significantly lower in patients who achieved an RVR compared to patients without an RVR (5.96 vs. 7 log10 IU/mL, p<0.0001). Median time to achieve plasma HCV RNA levels of <25 IU/mL was significantly shorter for patients in Group 1 vs. Group 3 (p=0.01). All 18 patients who achieved an RVR and received 3 weeks of treatment had an SVR 12 weeks after the end of treatment. Patients who achieved an RVR maintained their treatment regimen for a total of 3 weeks, while others continued treatment for 8-12 weeks. This month, data will be presented at the American Association for the Study of Liver Diseases meeting in San Francisco. ...