Johns Hopkins ABX Guide
Simeprevir
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INDICATIONS
FDA
- In combination with Peg-IFN and ribavirin, simeprevir is FDA indicated for the treatment of HCV genotype 1 in patients with compensated liver disease (including cirrhosis).
- Since lower efficacy has been observed in some studies in patients infected with HCV genotype 1a with NS3 Q80K* polymorphism, screening for this polymorphism at baseline is recommended if simeprevir use is planned.
- If NS3 Q80K polymorphism is detected, use of an alternative directly acting HCV regimen should be considered.
*In clinical trials, prevalence of Q80K polymorphism observed in 30% patients infected with HCV genotype1a and only 0.5% in patients infected with HCV genotype 1b.
NON-FDA APPROVED USES
Simeprevir plus sofosbuvir +/- ribavirin is a recommended first line regimen for the treatment of HCV genotype 1a and 1b. NS3 Q80K polymorphism for genotype 1a did not significantly impact sustained virologic response to this regimen.
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INDICATIONS
FDA
- In combination with Peg-IFN and ribavirin, simeprevir is FDA indicated for the treatment of HCV genotype 1 in patients with compensated liver disease (including cirrhosis).
- Since lower efficacy has been observed in some studies in patients infected with HCV genotype 1a with NS3 Q80K* polymorphism, screening for this polymorphism at baseline is recommended if simeprevir use is planned.
- If NS3 Q80K polymorphism is detected, use of an alternative directly acting HCV regimen should be considered.
*In clinical trials, prevalence of Q80K polymorphism observed in 30% patients infected with HCV genotype1a and only 0.5% in patients infected with HCV genotype 1b.
NON-FDA APPROVED USES
Simeprevir plus sofosbuvir +/- ribavirin is a recommended first line regimen for the treatment of HCV genotype 1a and 1b. NS3 Q80K polymorphism for genotype 1a did not significantly impact sustained virologic response to this regimen.
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