Janssen initiates Phase 3 trials of combination dose of simeprevir and sofosbuvir

Janssen R&D Ireland announced on Wednesday that it is recruiting approximately 400 patients for two Phase 3 trials of simeprevir and sofosbuvir, which treat chronic genotype 1 hepatitis C virus infection.

"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," Janssen Hepatitis Disease Area Leader Gaston Picchio said. "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, named OPTIMIST-1, is a Phase 3, multicenter, open-label, randomized study. The investigation will involve 150 mg of simeprevir and 400 mg of sofosbuvir administered once daily for eight or 12 weeks to patients without cirrhosis.

The second trial, known as OPTIMIST-2, is also a Phase 3, multicenter, open-label, randomized study. The same dose of medication will be administered to patients with cirrhosis once daily for 12 weeks. Ribavirin will not be used in either trial.

COSMOS final cohort 1 and cohort 2 interim results were presented at the American Association for the Study of Liver Diseases Annual Meeting 2013. Final cohort 2 results will be presented on April 12 at the International Liver Congress 2014 of the European Association for the Study of the Liver.