FDA approves Olysio and Sovaldi combo for HCV-Medivir/Janssen

The FDA has approved Olysio (simeprevir) in combination with Sovaldi (sofosbuvir), from Medivir and Janssen, as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic Hepatitis C infection in adult patients as part of a combination antiviral treatment regimen. Data supporting the Olysio and Sovaldi combination regimen are from the COSMOS study, an open-label, randomized phase II clinical trial. In the study 95 percent of patients with METAVIR F0-F3 (patients with no liver fibrosis to near cirrhotic liver disease) receiving 12 weeks of Olysio with sofosbuvir achieved SVR12 (sustained virologic response 12 weeks after the end of treatment).

Regardless of whether patients were treatment-naïve or treatment-experienced 86 percent of patients with METAVIR F4 (cirrhosis) receiving 12 weeks of the combination achieved SVR12, while 100 percent of patients with cirrhosis who were treated with the combination for 24 weeks achieved SVR12. For all patients in the trial (treatment-naïve and treatment-experienced, METAVIR F0-F4), 93 percent achieved SVR12 after 12 weeks and 97 percent achieved SVR12 after 24 weeks of treatment. The most common (> 10 percent) adverse reactions reported during 12 weeks of treatment with the combination without ribavirin were fatigue (25 percent), headache (21 percent) and nausea (21 percent).