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Simeprevir

Paul A. Pham, Pharm.D., David L. Thomas, M.D., M.P.H.
Simeprevir is a topic covered in the Johns Hopkins ABX Guide.

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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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Last updated: July 11, 2014

Citation

Pham, Paul A, and David L Thomas. "Simeprevir." Johns Hopkins ABX Guide, The Johns Hopkins University, 2014. Pediatrics Central, peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540636/all/Simeprevir.
Pham PA, Thomas DL. Simeprevir. Johns Hopkins ABX Guide. The Johns Hopkins University; 2014. https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540636/all/Simeprevir. Accessed March 19, 2019.
Pham, P. A., & Thomas, D. L. (2014). Simeprevir. In Johns Hopkins ABX Guide. Available from https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540636/all/Simeprevir
Pham PA, Thomas DL. Simeprevir [Internet]. In: Johns Hopkins ABX Guide. The Johns Hopkins University; 2014. [cited 2019 March 19]. Available from: https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540636/all/Simeprevir.
* Article titles in AMA citation format should be in sentence-case
TY - ELEC T1 - Simeprevir ID - 540636 A1 - Pham,Paul,Pharm.D. AU - Thomas,David,M.D., M.P.H. Y1 - 2014/07/11/ BT - Johns Hopkins ABX Guide UR - https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540636/all/Simeprevir PB - The Johns Hopkins University DB - Pediatrics Central DP - Unbound Medicine ER -