The U.S. Food and Drug Administration (FDA) has approved the combination therapy of OLYSIO^® (simeprevir), developed by Janssen R&D Ireland and Medivir AB, with sofosbuvir as an alternative treatment for genotype 1 chronic hepatitis C (CHC) infection in adult patients. The combination antiviral therapy of OLYSIO^® (simeprevir), a hepatitis C virus (HCV) NS3/4A protease inhibitor with Sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc., is an all-oral, interferon- and ribavirin-free treatment.

Hepatitis C is a disease of the liver caused by the hepatitis C virus, which is a blood-borne virus. The infection can cause liver damage, and patients that are chronically infected are likely to develop liver pathologies, such as cirrhosis (destruction of normal liver tissue) and cancer. The most usual routes of virus transmission are through unsafe injection practices; inadequate sterilization of medical equipment in some health-care settings; and untested blood and blood derivatives. Around 130–150 million people worldwide have chronic hepatitis C infection, often called a ‘silent killer,’ since it can be asymptomatic for many years. Approximately 350 to 500 thousand people die every year from hepatitis C-related liver diseases. Presently, there is no vaccine for hepatitis C, but antiviral therapies are successful in 50–90% of patients although access to diagnosis and treatment is low, only 3% of people with hepatitis C receive treatment each year.

The results for the approval of the therapy of OLYSIO^® with sofosbuvir are from the COSMOS study, an open-label, randomized Phase 2 clinical trial that evaluated the efficacy and safety of OLYSIO^® (150 mg once a day) in combination with sofosbuvir (400 mg once a day) for 12 or 24 weeks with or without ribavirin in adult patients chronically infected with HCV genotype 1 that were not given any previous treatment (naive), and treatment-experienced patients with compensated liver disease, i.e. with a functional diseased liver.

The combined treatment of OLYSIO^® with sofosbuvir is recommended for 12 weeks for patients without cirrhosis or 24 weeks for patients with cirrhosis. This indication was based on data from two cohorts of the COSMOS study published in The Lancet journal. Cohort 1 included non-responder patients, i.e. patients that failed prior interferon-based therapy, with no to moderate liver fibrosis (defined as METAVIR F0 to F2 scores), and Cohort 2 were treatment-naive patients (i.e. patients who have not received any other treatments previously), and prior non-responder patients to peg interferon alfa and ribavirin with near cirrhosis (METAVIR F3) and cirrhosis (METAVIR F4). The METAVIR scores measure the severity or stage of liver fibrosis, ranging from early to advanced stage.

In conclusion, all patients in the COSMOS trial (treatment-naive and treatment-experienced, METAVIR F0-F4), 93% (26/28) achieved undetectable HCV viral load 12 weeks after completion of therapy (SVR12), and 97% of the patients (30/31) achieved undetectable HCV viral load 24 weeks after completion (SVR24). After 12 and 24 weeks of treatment, viral relapse occurred, respectively, in 7% of patients (2/28) and 0% of the patients (0/30).

“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, in the press release. “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,” added Dr. Eric Lawitz.

“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.”

“We’re pleased that an interferon-free, ribavirin-free OLYSIO^®-based combination is now approved in the United States for patients with genotype 1 chronic hepatitis C infection. The availability of multiple treatment options is important to help offer an opportunity for cure and we believe OLYSIO^® will play a meaningful role in this respect,” said Gaston Picchio, PhD., Hepatitis disease area leader, Janssen Research & Development, LLC. “We’re passionate about finding new treatment options for patients living with hepatitis C worldwide and will continue to pursue innovative approaches to help address this disease.”

Currently, Janssen R&D is pursuing the program of clinical development for OLYSIO^®, including Phase 3 study commitments. For more information please visit www.clinicaltrials.gov.