Two new Phase III trials of TMC 435/GS 7977 for Hepatitis C-Janssen

Janssen R&D has announced that two Phase III trials are recruiting patients to examine the efficacy and safety of TMC 435 (simeprevir) in combination with GS 7977 (sofosbuvir) for the treatment of chronic genotype 1 Hepatitis C virus (HCV) infection in treatment-naive and treatment-experienced patients with and without cirrhosis. The first trial, known as OPTIMIST-1 or TMC435HPC3017, is a 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 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.