Janssen announced that the Food and Drug Administration (FDA) has approved Olysio (simeprevir) in combination with sofosbuvir as an oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis (CHC) infection in adults as part of a combination antiviral treatment regimen.
Olysio, a hepatitis C virus (HCV) NS3/4A protease inhibitor, was initially approved in November 2013 for use in combination with peginterferon alfa and ribavirin in patients with compensated liver disease, including cirrhosis. Sofosbuvir (marketed as Sovaldi; Gilead) is an HCV NS5B polymerase inhibitor.
The expanded approval was based on data from the COSMOS study, an open-label, randomized Phase 3 clinical trial that studied the efficacy and safety of 12 or 24 weeks of Olysio 150mg once daily plus sofosbuvir 400mg once daily with or without ribavirin in HCV genotype 1 infected treatment-naive and treatment-experienced adults with compensated liver disease.
Data from pooled analyses showed that 95% of patients with METAVIR F0-F3 scores treated with Olysio plus sofosbuvir for 12 weeks achieved sustained virologic response (SVR12) or cure by the end of treatment. Also, 86% of patients with METAVIR F4 scores treated with Olysio plus sofosbuvir for 12 weeks achieved SVR12, and 100% of patients with cirrhosis treated for 24 weeks achieved SVR12.
For more information call (800) 526-7736 or visit Olysio.com.