The cost‐effectiveness of testing for NS5a 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

• Published in: Alimentary pharmacology & therapeutics Vol. 45; no. 3; pp. 455 - 467
• Main Authors: Elbasha, E. H., Robertson, M. N., Nwankwo, C.
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.02.2017; John Wiley and Sons Inc
• Subjects: Administration, Oral; Amides; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; Benzofurans - administration & dosage; Benzofurans - adverse effects; Carbamates; Chronic infection; Cirrhosis; Clinical trials; Cost analysis; Cost-Benefit Analysis; Cyclopropanes; Drug Resistance, Viral - genetics; Drug Therapy, Combination; Elbasvir plus Grazoprevir for HCV; Genotype; Hepacivirus - genetics; Hepatitis C, Chronic - diagnosis; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - economics; Hepatitis C, Chronic - virology; Humans; Imidazoles - administration & dosage; Imidazoles - adverse effects; Liver cirrhosis; Liver Cirrhosis - drug therapy; Liver Cirrhosis - virology; Liver diseases; Original; Polymorphism, Genetic; Predictive Value of Tests; Quinoxalines - administration & dosage; Quinoxalines - adverse effects; Ribavirin; Ritonavir; Sulfonamides; United States; Viral Nonstructural Proteins - genetics; Virology - economics; Virology - methods; United States
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/apt.13882

Summary Background The presence of baseline NS5A resistance‐associated variants (RAVs) impacted treatment response in HCV genotype 1a (GT1a)‐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 NS5A RAVs in EBR/GZR‐treated patients compared without testing, and with current treatments for GT1a 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 GT1a patients. Treatment‐related data from clinical trials were used in a state‐transition model of the natural history of chronic HCV GT1a 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 RAVs testing‐guided treatment with EBR/GZR resulted in more QALYs than EBR/GZR without testing, 3D+RBV, or LDV/SOF8. This strategy was cost‐saving relative to 3D+RBV or LDV/SOF8 and was cost‐effective compared with EBR/GZR without testing. LDV/SOF12 was not cost‐effective compared with the EBR/GZR RAVs testing‐based strategy. Treatment with EBR/GZR guided by RAVs testing is the most effective regimen among treatment‐experienced patients without cirrhosis and cirrhotic patients. In sensitivity analysis, RAVs testing was cost‐effective in 48–55% and 63–85% among noncirrhotic and cirrhotic patients respectively. Conclusions RAVs 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 GT1a treatment‐naïve or treatment‐experienced patients.