Enanta Pharmaceuticals announced results from AbbVie’s Phase 2b PEARL-I study with ABT-450/ritonavir and ombitasvir, an all-oral, interferon-free investigational treatment combining two direct-acting antivirals with or without ribavirin in patients with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection.
This open-label study investigated the use of ABT-450/ritonavir and ombitasvir with or without ribavirin for 12 weeks in non-cirrhotic adult patients with chronic genotype 1b and GT4 HCV infection. Results from this study demonstrated that 100% of GT4 patients who were new to therapy (n=42/42) or who had failed previous treatment with pegylated interferon (pegIFN) and RBV (n=49/49) achieved sustained virologic response rates at 12 weeks post-treatment (SVR12) after taking AbbVie’s investigational treatment with RBV. Additionally, 90.9% of patients who were new to therapy achieved SVR12 (n=40/44) after taking the treatment without RBV.
ABT-450 is being developed by AbbVie in a two-direct-acting-antiviral (2-DAA) treatment regimen and a 3-DAA treatment regimen for HCV. The investigational, all-oral, 2-DAA regimen consists of the fixed-dose combination of ABT-450/ritonavir co-formulated with ombitasvir, co-administered with or without weight-based ribavirin. The investigational, all-oral, 3-DAA regimen consists of the fixed-dose combination of ABT-450/ritonavir co-formulated with ombitasvir and dasabuvir, with or without ribavirin.