Olysio indication expanded for combo use with Sovaldi in hepatitis C

November 6, 2014

FDA has approved simeprevir (Olysio, Janssen) in combination with sofosbuvir (Sovaldi, Gilead) as an oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis infection in adults.

FDA has approved simeprevir (Olysio, Janssen) in combination with sofosbuvir (Sovaldi, Gilead) as an oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis infection in adults.

“This is actually very important,” said FormularyWatch advisor James M. Wooten, PharmD, associate professor, department of medicine, section of clinical pharmacology, University of Missouri-Kansas City. “Hepatitis Cis not an uncommon disease so the more medications we have to combat the virus the better for patients. There will probably be other treatment recommendations regarding hepatitis C in the near future.”

Olysio, an NS3/4A protease inhibitor, was approved in November 2013 for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis. Sofosbuvir is an HCV NS5B polymerase inhibitor.

Drugs in Perspective: Sovaldi (sofosbuvir)

"[Hepatitis C] is a very competitive market, as a number of companies are looking to compete with Gilead's products due to the large population of patients and the high earnings potential for drug sales," said John Santilli, of Access Market Intelligence, which provides market intelligence to the pharmaceutical and healthcare industries. 

"[Olysio] has shown to be synergistic with Sovaldi and has led to high cure rates in genotype 1 patients," Santilli added. "With Gilead's introduction of single, once-daily pill Harvoni, there may be a price war with Olysio/Sovaldi. In this case, Harvoni will have a decided competitive advantage." 

Is a hep C price war headed our way?

According to the Monthly Prescribing Reference, 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 150 mg once daily plus sofosbuvir 400 mg once daily with or without ribavirin in HCV genotype 1 infected treatment-naive and treatment-experienced adults with compensated liver disease.

Ninety-five percent 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, according to data from pooled analyses. In addition, 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.