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Summary   Background  The presence of baseline  NS 5A resistance‐associated variants ( RAV s) impacted treatment response in  HCV  genotype 1a ( GT 1a)‐infected patients treated with elbasvir/grazoprevir ( EBR / GZR ) for 12 weeks, but not patients treated with  EBR / GZR  and ribavirin ( RBV ) for 16 weeks.    Aims  To assess the cost‐effectiveness of baseline testing for  NS 5A  RAV s in  EBR / GZR ‐treated patients compared without testing, and with current treatments for  GT 1a patients.    Methods  We simulated the course of treatment with  EBR / GZR , ledipasvir/sofosbuvir ( LDV / SOF ) and ombitasvir/paritaprevir/ritonavir+dasabuvir (3D) with or without  RBV  and natural history of disease of  GT 1a patients. Treatment‐related data from clinical trials were used in a state‐transition model of the natural history of chronic  HCV GT 1a infection and liver disease to project lifetime costs ( US $2015) and quality‐adjusted life years ( QALY ). Other clinical and economic inputs were estimated from published sources. We conducted base case and sensitivity analyses.    Results   RAV s testing‐guided treatment with  EBR / GZR  resulted in more  QALY s than  EBR / GZR  without testing, 3D+ RBV , or  LDV / SOF 8. This strategy was cost‐saving relative to 3D+ RBV  or  LDV / SOF 8 and was cost‐effective compared with  EBR / GZR  without testing.  LDV / SOF 12 was not cost‐effective compared with the  EBR / GZR RAV s testing‐based strategy. Treatment with  EBR / GZR  guided by  RAV s testing is the most effective regimen among treatment‐experienced patients without cirrhosis and cirrhotic patients. In sensitivity analysis,  RAV s testing was cost‐effective in 48–55% and 63–85% among noncirrhotic and cirrhotic patients respectively.    Conclusions   RAV s testing before treatment with  EBR / GZR  is likely to be a cost‐effective alternative to the use of  EBR / GZR  without testing,  LDV / SOF , or 3D among  GT 1a treatment‐naïve or treatment‐experienced patients.

alimentary pharmacology and therapeutics

The cost‐effectiveness of testing for  NS 5a resistance‐associated polymorphisms at baseline in genotype 1a‐infected (treatment‐naïve and treatment‐experienced) subjects treated with all‐oral elbasvir/grazoprevir regimens in the United States