Janssen R&D Ireland (Janssen) announced today that two Phase 3 trials are recruiting patients to examine the efficacy and safety of the NS3/4A protease inhibitor simeprevir in combination with the nucleotide inhibitor sofosbuvir for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in treatment-naive and treatment-experienced patients with and without cirrhosis.
Simeprevir is approved in the U.S., Canada, Japan and Russia for the treatment of genotype 1 HCV as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin and the Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending Marketing Authorisation in the European Union for the use of simeprevir in combination with other medicinal products for the treatment of chronic HCV. The combination of simeprevir and sofosbuvir was previously evaluated in the Phase 2 COSMOS trial.
"The combination of simeprevir and sofosbuvir with and without ribavirin demonstrated efficacy and safety in treatment-naive and treatment-experienced patients, including those with cirrhosis, in the Phase 2 COSMOS study," said Gaston Picchio, Hepatitis Disease Area Leader, Janssen. "The initiation of these Phase 3 clinical trials is the latest fulfillment of Janssen's commitment to investigate the utility of simeprevir for patients with chronic hepatitis C infection."
The first trial, known as OPTIMIST-1 (Optimal Treatment with a simeprevir and sofosbuvir Therapy) or TMC435HPC3017, is a Phase 3, multicenter, open-label, randomized study investigating the efficacy and safety of simeprevir 150 mg in combination with sofosbuvir 400 mg. The combination will be administered once daily for 8 or 12 weeks in chronic HCV genotype 1 infected patients without cirrhosis who are HCV treatment naive or treatment experienced. The second trial, known as OPTIMIST-2 or TMC435HPC3018, is a Phase 3, multicenter, open-label, single-arm study investigating the efficacy and safety of simeprevir 150 mg in combination with sofosbuvir 400 mg. The combination will be administered once daily for 12 weeks in HCV genotype 1 infected patients with cirrhosis who are HCV treatment naive or treatment experienced. Ribavirin will not be administered in the OPTIMIST trials.
The primary efficacy endpoint in each study is the proportion of patients achieving sustained virologic response 12 weeks after the end of treatment (SVR12). The studies will seek to enroll approximately 400 patients in the U.S. and Canada.
The final cohort 1 study results (SVR12) and the interim cohort 2 study results (SVR4) from the COSMOS study were presented as a late-breaker abstract at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting 2013 in Washington, D.C. Final cohort 2 results (SVR12) have been accepted for presentation at the International Liver Congress 2014™ of the European Association for the Study of the Liver (EASL) on April 12. For additional information, including inclusion and exclusion criteria for these trials, please visit www.clinicaltrials.gov.
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