Alisporivir: Additional Phase IIb data

Additional data from the open-label, international Phase IIb VITAL-1 trial in 340 previously untreated patients with chronic HCV genotypes 2 or 3 infection showed that 95% and 88% of 70 evaluable patients who received only peginterferon alfa-2a-free alisporivir plus ribavirin achieved an end of treatment response at week 24 and an SVR 12 weeks after the end of treatment, respectively, vs. 88% and 72% of patients who received peginterferon alfa-2a and ribavirin alone. In 177 evaluable patients who received peginterferon alfa-2a-free alisporivir plus ribavirin at baseline and added peginterferon alfa-2a at week 6, 97% and 90% achieved an end of treatment response at week 24 and an SVR 12 weeks after the end of treatment, respectively. At week 4, patients in the alisporivir arms who achieved undetectable HCV RNA levels (<25 IU/mL) remained on their initial treatment for 24 weeks, while patients with detectable HCV RNA levels received alisporivir plus peginterferon alfa-2a and ribavirin from weeks 6-24. Data were presented at the European Association for the Study of the Liver meeting in Barcelona.

The partners previously reported interim data from 334 patients showing that 49% of patients receiving once-daily 600 or 800 mg alisporivir plus ribavirin achieved undetectable HCV RNA levels (<25 IU/mL) by week 6. Additionally, 32% of patients receiving once-daily 1,000 mg alisporivir as monotherapy achieved undetectable HCV RNA levels by week 6, and 92% of patients receiving once-daily 600 mg alisporivir plus peginterferon alfa-2a and 100% of patients receiving peginterferon alfa-2a and ribavirin alone achieved undetectable HCV RNA levels at week 8. Furthermore, 97% of patients receiving alisporivir plus ribavirin maintained undetectable HCV RNA levels up to week 12 (see BioCentury, Nov. 14, 2011). ...