Chronic Hepatitis C Treatment Submitted for Labeling Update

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The sNDA is based on results from two phase-3 trials.
The sNDA is based on results from two phase-3 trials.

Officials with Janssen Therapeutics announced the submission of a supplemental new drug application to the Food and Drug Administration to update the label for once-daily, all-oral simeprevir (Olysio) in combination with sofosbuvir for adults with genotype 1 chronic hepatitis C (CHC) infection with or without cirrhosis.

The application is based on results from two phase-3 trials. OPTIMIST-1 is a randomized, open-label trial to investigate the efficacy and safety of the all-oral regimen of simeprevir and sofosbuvir (SMV/SOF) among treatment-naive and treatment-experienced genotype 1 CHC patients without cirrhosis. 

The primary study endpoint is sustained virologic response (SVR) at 12 weeks after treatment (SVR12) with 12 and eight weeks of treatment with SMV/SOF versus a historical control. 

About 97% of patients treated with SMV/SOF for 12 weeks (n=150/155) achieved SVR12, which was superior to the SVR12 rate of 87% among the historical control.

OPTIMIST-2 is an open-label, single-arm trial to investigate the efficacy and safety of SMV/SOF in treatment-naive and treatment-experienced genotype 1 CHC patients with cirrhosis. The primary endpoint is SVR12 with SMV/SOF versus a historical control. 

weeks of treatment with SMV/SOF resulted in SVR12 rates of 84% (n=86/103), which was superior to the SVR12 rate of 70% in the historical control.

Simeprevir (Olysio) is an NS3/4A protease inhibitor. Sofosbuvir (Gilead) is a nucleotide analog NS5B polymerase inhibitor.

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