Alisporivir: Phase II data

The double-blind, international Phase II FUNDAMENTAL (A2210) trial in 461 patients with chronic HCV genotype 1 infection who relapsed or were non-responders to standard of care (SOC; peginterferon alfa-2a and ribavirin) showed that alisporivir plus SOC met the primary endpoint of a greater proportion of patients achieving a cEVR defined as undetectable HCV RNA levels (<25 IU/mL) at week 12 vs. placebo plus SOC. Specifically, 72%, 46% and 61% of patients receiving twice-daily 400 mg, once-daily 600 mg and once-daily 800 mg alisporivir plus SOC, respectively, achieved a cEVR vs. 33% for placebo plus SOC (p<0.00001, p=not disclosed and p=not disclosed). Additionally, a greater proportion of patients receiving each respective regimen of alisporivir plus SOC achieved a rapid virologic response (RVR) defined as undetectable HCV RNA levels at week 4 vs. placebo plus SOC (41%, 22% and 25%, respectively, vs. 7%; p<0.0001, p=not disclosed and p=not disclosed). Alisporivir was well tolerated. The trial was designed to evaluate placebo plus SOC or twice-daily 400 mg, once-daily 600 mg or once-daily 800 mg alisporivir plus SOC for 48 weeks. Data were presented at the European Association for the Study of the Liver meeting in Barcelona. ...