Hepatitis C Virus Combination Antiviral Drug Moving to Phase 3 Trial

Two Phase 3 trials are being initiated by Janssen to examine the efficacy of simeprevir in combination with sofosbuvir for the treatment of chronic genotype 1 hepatitis C virus (HCV), the company announced. The combination of drugs was previously tested in a phase 2 trial.

Simeprevir, an NS3/4A protease inhibitor, is approved for use in the US, Canada, Japan, and Russia for the treatment of HCV. The Phase 3 OPTIMIST trials will administer simeprevir 150 mg and sofosbuvir 400 mg once daily for 8 or 12 weeks to approximately 400 HCV treatment-naïve and treatment-experienced patients.

In the previous phase 2 COSMOS trial, the combination of simeprevir and sofosbuvir with and without ribavirin demonstrated efficacy and safety in treatment-naïve and treatment-experienced patients, including those with liver cirrhosis. The patients will not be given ribavirin in the OPTIMIST trials.

The study aims to measure the proportion of patients achieving sustained virologic response after 12 weeks of treatment.