DAUPHINE: a randomized phase II study of danoprevir/ritonavir plus peginterferon alpha-2a/ribavirin in HCV genotypes 1 or 4

Background & Aims Danoprevir is a hepatitis C virus (HCV) protease inhibitor with activity against genotypes (G)1/G4, which is maintained at lower doses by ritonavir‐boosting. We report results of a large, randomized, active‐controlled phase IIb study of ritonavir‐boosted danoprevir (danoprevir/r) plus peginterferon alpha‐2a/ribavirin (P/R) in treatment‐naive patients with HCV G1/4 infection. Methods Treatment‐naive patients with HCV G1/4 infection were randomized to twice‐daily danoprevir/r 200/100 mg (A, n = 92); 100/100 mg (B, n = 93); or 50/100 mg (C, n = 94) plus P/R for 24 weeks; twice‐daily danoprevir/r 100/100 mg (D, n = 94) plus P/R for 12 or 24 weeks; or P/R alone (E, n = 44) for 48 weeks. Patients in the response‐guided therapy arm (D) with an extended rapid virological response (eRVR2: HCV RNA