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-born infectious disease of the liver that affects an estimated 3.2 million people in the U.S. Approximately 75 to 85 percent of people who become infected with HCV develop chronic infection. Most persons with CHC infection are asymptomatic, which means they do not show symptoms of the disease. 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.
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.
"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.
The data for this expanded indication are based on two cohorts in the COSMOS study, published in The Lancet. Cohort 1 included prior non-responder patients (patients who failed prior interferon-based therapy) with no to moderate liver fibrosis (defined as METAVIR F0 to F2 scores), and Cohort 2 included treatment-naïve patients (patients who have not received other treatments previously) and prior non-responder patients to peginterferon alfa and ribavirin near cirrhosis (METAVIR F3) and with cirrhosis (METAVIR F4). METAVIR scores measure the severity or stage of liver fibrosis, from early to advanced.
In pooled analyses of both cohorts, 95 percent of patients (20/21) with METAVIR F0-F3 receiving 12 weeks of OLYSIO® with sofosbuvir achieved sustained virologic response (SVR12) or cure, the absence of HCV detected in the blood 12 weeks after the end of treatment. Viral relapse occurred in 5 percent (1/21) and 0 percent (0/20) of patients with METAVIR F0-F3 after 12 or 24 weeks of combination therapy, respectively. Regardless of whether patients were treatment-naïve or treatment-experienced, 86 percent of patients (6/7) with METAVIR F4 receiving 12 weeks of OLYSIO® in combination with sofosbuvir achieved SVR12, while 100 percent of patients (10/10) with cirrhosis who were treated with the combination for 24 weeks achieved SVR12. Viral relapse occurred in 14 percent (1/7) and 0 percent (0/10) of patients with cirrhosis after 12 or 24 weeks of combination therapy, respectively.
For all patients in the COSMOS trial (treatment-naïve and treatment-experienced, METAVIR F0-F4), 93 percent (26/28) achieved SVR12 after 12 weeks and 97 percent (30/31) achieved SVR12 after 24 weeks of treatment. Viral relapse occurred in 7 percent of patients (2/28) after 12 weeks and 0 percent of patients (0/30) after 24 weeks of treatment overall.
In the COSMOS trial, the most common (> 10 percent) adverse reactions reported during 12 weeks of treatment with OLYSIO® in combination with sofosbuvir without ribavirin were fatigue (25 percent), headache (21 percent), nausea (21 percent), insomnia (14 percent) and pruritus (11 percent). Rash and photosensitivity were reported in 11 percent and 7 percent of patients, respectively. During 24 weeks of treatment with OLYSIO® in combination with sofosbuvir, dizziness (16 percent), and diarrhea (16 percent) were also commonly reported.
Prior to initiation of treatment with OLYSIO® with sofosbuvir, screening patients infected with HCV genotype 1a for the presence of virus with the NS3 Q80K polymorphism is not strongly recommended but may be considered.
Janssen is continuing its clinical development program for OLYSIO®, including Phase 3 study commitments. For more information please visit www.clinicaltrials.gov.
"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."