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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
Author(s) -
Elbasha E. H.,
Robertson M. N.,
Nwankwo C.
Publication year - 2017
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.13882
Subject(s) - medicine , ombitasvir , regimen , ribavirin , gastroenterology , virology , hepatitis c virus , virus
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.