Simeprevir indications and usage
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Indications And Usage
OLYSIO™ is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
- OLYSIO efficacy has been established in combination with peginterferon alfa and ribavirin, in HCV genotype 1 infected subjects with compensated liver disease (including cirrhosis) [see Clinical Studies (14)].
The following points should be considered when initiating OLYSIO for treatment of chronic hepatitis C infection:
- OLYSIO must not be used as monotherapy [see Warning and Precautions (5.5)].
- OLYSIO efficacy in combination with peginterferon alfa and ribavirin is influenced by baseline host and viral factors [see Clinical Pharmacology (12.5) and Clinical Studies (14)].
- OLYSIO efficacy in combination with peginterferon alfa and ribavirin is substantially reduced in patients infected with HCV genotype 1a with an NS3 Q80K polymorphism at baseline compared to patients infected with hepatitis C virus (HCV) genotype 1a without the Q80K polymorphism [see Microbiology (12.4) andClinical Studies (14)]. Screening patients with HCV genotype 1a infection for the presence of virus with the NS3 Q80K polymorphism at baseline is strongly recommended. Alternative therapy should be considered for patients infected with HCV genotype 1a containing the Q80K polymorphism.
- OLYSIO efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes OLYSIO or other HCV protease inhibitors[see Microbiology (12.4)].[1]
References
- ↑ "OLYSIO (SIMEPREVIR) CAPSULE [JANSSEN PRODUCTS LP]". Retrieved 7 January 2014.
Adapted from the FDA Package Insert.