November 24, 2013
By Patricia Emory
OLYSIO™ (simeprevir) was approved in the United States November 22, 2013 by the FDA for the treatment of hepatitis C patients in conjunction with pegylated interferon and ribavirin in adult patients (treatment-naive and treatment-experienced) with genotype 1 including those with compensated cirrhosis.
OLYSIO™ (simeprevir) is a “2nd generation” NS3/4A protease inhibitor which acts by blocking the protease enzyme that enables the virus to replicate.
Dosing and Duration of treatment
Dosing: Fixed dose of 150mg once a day
Duration of Treatment:
Treatment-naïve and prior-relapsers: 12 weeks of Simeprevir in combination with 24 weeks of pegylated interferon and ribavirin
Partial and null-responders: 12 weeks of Simeprevir in combination with 48 weeks of pegylated interferon and ribavirin
The most common adverse effects of Simeprevir are rash and sensitivity to sunlight (most common in the first 4 weeks of treatment) as well as those associated with pegylated interferon and ribavirin.
Q80K polymorphism is found in 56.7% of genotype 1a patients in the US. The Q80K polymorphism greatly reduces treatment response. It is suggested that all patients being considered for treatment using Simeprevir be screened for the Q80K polymorphism.
According to the OLYSIO™ website:
“Information on financial assistance through OLYSIO™ Support will be available soon. In the meantime, please call1-800-JANSSEN (1-800-526-7736) for information.”
OLYSIO™ (simeprevir) website
OLYSIO™ (simeprevir) Receives FDA Approval for Combination Treatment of Chronic Hepatitis C – Janssen Press Release
FDA approves new treatment for hepatitis C virus – FDA Press Release
FDA Antiviral Drugs Advisory Committee Meeting Briefing Document