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Olysio gains additional FDA approval as once-daily, all-oral treatment combination for chronic hepatitis C

Janssen Therapeutics, Division of , LP (Janssen) has announced the U.S. (FDA) has approved OLYSIO® (simeprevir), a (HCV) NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free for genotype 1 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-born infectious disease of the liver that affects an estimated 3.2 million people in the U.S.[iii] Approximately 75 to 85 percent of people who become infected with HCV develop chronic infection.[iv] Most persons with CHC infection are asymptomatic, which means they do not show symptoms of the disease.[v] 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.[vi]

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-na├»ve and treatment-experienced adult patients with compensated .

“It’s a very encouraging time for patients with chronic hepatitis as the advent of new direct-acting treatment combinations, like OLYSIO® plus sofosbuvir offer all-oral, interferon- and ribavirin-free treatment options,” said Eric Lawitz, M.D., primary investigator for the COSMOS clinical study, and vice president, Scientific and Research Development, The Texas Liver Institute and professor of medicine, University of Texas Health Science Center. “The availability of multiple treatment options is important to physicians and patients so optimal treatment decisions can be made, given the complexity of the disease and diversity of patient population.”

“I lived with hepatitis C for nearly thirty years,” said Norman Walsh, a COSMOS clinical trial patient. “I will never forget the moment that my clinical trial healthcare team told me the news following my treatment with the combination of OLYSIO® and sofosbuvir. I was elated, relieved – and cured.”*

OLYSIO® in Combination with Sofosbuvir in HCV Adult, Genotype 1 Patients
The recommended treatment duration of OLYSIO® with sofosbuvir is 12 weeks for patients without cirrhosis or 24 weeks for patients with cirrhosis.