Janssen begins new studies of hepatitis C therapy

Janssen has announced the commencement of a pair of phase III clinical trials of an innovative new therapy for hepatitis C.

The company has begun recruiting patients for two studies 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 infection.

Treatment-naive and treatment-experienced patients with and without cirrhosis will be enrolled in the trials, which are the first phase III studies to assess the two treatments in a regimen without interferon and ribavirin.

It is hoped that results from the new studies will build upon the positive findings from the phase II trial COSMOS.

Gaston Picchio, hepatitis disease area leader at Janssen, said: "The initiation of these phase III clinical trials is the latest fulfillment of Janssen's commitment to investigate the utility of simeprevir for patients with chronic hepatitis C infection."

This comes after the firm recently allied with Bayer HealthCare on two new studies assessing the anticoagulant rivaroxaban in medically-ill patients and children at high risk for blood clots.