In the US, Canada, Japan and Russia, simeprevir is approved to treat genotype 1 HCV as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation in the EU for the use of simeprevir in combination with other medicinal products for the treatment of chronic HCV.
According to the company, the combination of simeprevir and sofosbuvir was previously evaluated in the Phase II COSMOS trial.
The first trial called OPTIMIST-1 (Optimal Treatment with a simeprevir and sofosbuvir Therapy), is a Phase III, multicenter, open-label, randomized study investigating the efficacy and safety of simeprevir 150mg in combination with sofosbuvir 400mg.
In this trial, the combination drug will be given once daily for eight or 12 weeks in chronic HCV genotype 1 infected patients without cirrhosis who are HCV treatment naive or treatment experienced.
The second multicenter, open-label, single-arm Phase III trial called OPTIMIST-2 will also assess the efficacy and safety of simeprevir 150mg in combination with sofosbuvir 400 mg.
The combination will be given once daily for 12 weeks in HCV genotype 1 infected patients with cirrhosis who are HCV treatment naive or treatment experienced.