Janssen Therapeutics, Division of Janssen Products, LP (Janssen) announced the U.S. Food and Drug Administration (FDA) has approved Olysio (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.

HCV is a blood-borne infectious disease of the liver that affects an estimated 3.2 million people in the U.S.[1] Approximately 75 to 85 percent of people who become infected with HCV develop chronic infection.[2] Most persons with CHC infection are asymptomatic, which means they do not show symptoms of the disease.[3] When left untreated, CHC infection may cause significant liver damage, including cirrhosis, which is severe scarring of the liver. CHC may also increase the risk of developing complications from cirrhosis, which may include liver failure.[4]

Data supporting the Olysio and sofosbuvir combination regimen are from the COSMOS study, an open-label, randomized Phase 2 clinical trial that investigated the efficacy and safety of 12 or 24 weeks of Olysio (150 mg once daily) in combination with sofosbuvir (400 mg once daily) with or without ribavirin in HCV genotype 1 chronically infected treatment-naïve and treatment-experienced adult patients with compensated liver disease.

For more details, go to: http://www.jnj.com/news/all/OLYSIO-simeprevir-Gains-Additional-FDA-Approval-as-Once-Daily-All-Oral-Interferon-and-Ribavirin-Free-Treatment-Option-in-Combination-with-Sofosbuvir-for-Adults-with-Genotype-1-Chronic-Hepatitis-C-Infection