Faldaprevir: Phase III data

The double-blind, international Phase III STARTVerso 1 trial in 652 treatment-naïve patients with chronic HCV genotype 1 infection showed that the once-daily 120 and 240 mg regimens of oral faldaprevir plus peginterferon alfa-2a and ribavirin each met the primary endpoint of a greater proportion of patients achieving an SVR 12 weeks after the end of treatment vs. placebo (79% and 80%, respectively, vs. 52%, p<0.0001 for both). In patients who achieved early treatment success, 86% in the 120 mg faldaprevir arm (n=226) and 89% in the 240 mg faldaprevir arm (n=233) achieved an SVR12. Faldaprevir was well tolerated. Elevations in unconjugated bilirubin levels were observed in both faldaprevir arms but were reversible and not accompanied by increases in liver enzymes. The most common adverse events reported were anemia, rash and gastrointestinal issues.

Patients received once-daily 120 or 240 mg faldaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks. Patients who achieved early treatment success defined as HCV RNA levels below the limit of quantification at week 4 and below the limit of detection at week 8 were eligible to stop peginterferon alfa-2a and ribavirin treatment at week 24. Patients in the 120 mg faldaprevir arm who did not achieve early treatment success were re-randomized to receive 12 additional weeks of faldaprevir plus peginterferon alfa-2a and ribavirin followed by 24 weeks of peginterferon alfa-2a and ribavirin, or placebo plus peginterferon alfa-2a and ribavirin for 12 additional weeks. Patients in the 240 mg faldaprevir arm who did not achieve early treatment success received placebo plus peginterferon alfa-2a and ribavirin for 12 additional weeks followed by 24 weeks of peginterferon alfa-2a and ribavirin. Patients in the control arm received 24 weeks of placebo plus peginterferon alfa-2a and ribavirin followed by 24 weeks of peginterferon alfa-2a and ribavirin. Data were presented at the European Association for the Study of the Liver meeting in Amsterdam. ...