AbbVie announced that the Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review to its all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/R) with ribavirin (RBV) for the treatment of adults with chronic genotype 4 (GT4) hepatitis virus (HCV) infection.
The FDA granted priority review to the regimen based partly on data from the PEARL-I study. PEARL-I is an open-label, Phase 2b study designed to evaluate the safety and efficacy of 12 weeks of treatment with OBV/PTV/R with or without RBV in non-cirrhotic adults with chronic GT4 HCV infection who were new to therapy or had failed previous treatment with pegylated interferon and RBV. Results demonstrated that 100% of GT4 patients without cirrhosis who were new to therapy (n=42/42) or who had failed previous treatment with pegylated interferon (pegIFN) and RBV (n=49/49) achieved SVR12 after receiving OBV/PTV/r and RBV for 12 weeks. Additionally, 91% of patients who were new to therapy achieved SVR12 (n=40/44) after taking the treatment without RBV.
AbbVie’s regimen was also granted Breakthrough Therapy designation by the FDA in 2014.
For more information call (800) 633-9110 or visit AbbVie.com.