Olysio Label Update Includes Data on Patients of East Asian Ancestry

The approval is based on a Phase 3 study of 304 patients
The approval is based on a Phase 3 study of 304 patients

The Food and Drug Administration (FDA) has approved a label update for Olysio (simeprevir; Janssen) to include pharmacokinetic, safety, and efficacy data in treatment-naive adult patients of East Asian ancestry with chronic hepatitis C virus (HCV)genotype 1 infection. 

A Phase 3 study conducted in China and South Korea (TIGER) demonstrated a 2.1-fold higher plasma exposure of simeprevir in East Asian subjects with HCV infection compared with non-Asian HCV infected subjects in a pooled Phase 3 population from global studies. Though higher plasma exposures were seen, no dose adjustment is required based on race. 

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The randomized, double-blind, placebo-controlled trial evaluated Olysio in combination with peginterferon alfa 2a and ribavirin in 304 treatment-naive patients with HCV genotype 1 infection. Patients received 12 weeks of once-daily Olysio 150mg in combination with peginterferon alfa 2a and ribavirin, followed by 12 or 36 weeks of peginterferon alfa 2a and ribavirin or 12 weeks of placebo in combination with peginterferon alfa and ribavirin, followed by 36 weeks of peginterferon alfa 2a and ribavirin. 

Sustained virologic rates 12 weeks post-treatment (SVR12) were 91% in the Olysio treatment arm vs. 76% in the placebo treatment arm.

The East Asian subjects exhibited a similar safety profile to that of the pooled Phase 3 population from global trials. Patients receiving Olysio 150mg in combination with peginterferon alfa 2a and ribavirin showed a higher incidence of hyperbilirubinemia vs. patients receiving placebo plus peginterferon alfa and ribavirin; bilirubin elevations were primarily Grade 1 or 2. 

Olysio, an HCV NS3/4A protease inhibitor, is indicated for the treatment of chronic hepatitis C genotype 1 or 4 infection as a component of a combination antiviral treatment regimen. 

For more information call (800) 526-7736 or visit Olysio.com.

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