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( Jennifer R. Kramer ),( Amy Puenpatom ),( Kevin Erickson ),( Yumei Cao ),( Donna L. Smith ),( Eirum Chaudhri ),( Hashem B. El-serag ),( Fasiha Kanwal ),( Eungeol Sim ) 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: Elbasvir/grazoprevir (EBR/GZR) is indicated for the treatment of chronic hepatitis C virus (HCV) genotype (GT) 1 and 4 infections and has demonstrated high sustained virologic response (SVR) in many HCV populations, including those with chronic kidney disease (CKD). The aim of this study was to evaluate the effectiveness of EBR/GZR in people with HCV infection and CKD in a real-world clinical setting. Methods: We conducted a nationwide retrospective observational cohort study of HCV-infected people in the US Department of Veterans Affairs (VA) using the VA Corporate Data Warehouse. The study population included people with RNA positive for HCV who initiated EBR/GZR between February 1 and December 1, 2016. Estimated glomerular filtration rate (eGFR), calculated per Kidney Disease Outcome Quality Initiative guidelines, was used to determine CKD stages. Results: A total of 2436 HCV-infected veterans treated with EBR/GZR ± ribavirin (RBV) were included in the evaluable population: 1611 (66.1%) had baseline eGFR >60 mL/min/1.73㎡, 393 (16.1%) had CKD stage 3 (eGFR, 30-59 mL/min/1.73㎡), and 407 (16.7%) had CKD stages 4-5 (eGFR < 30 mL/min/1.73㎡). The mean age was 63.5 years (SD=5.9). Most participants were male (96.5%), African American (57.4%), and had HCV genotype 1 infection (95.4%). Other comorbidities in these participants included cirrhosis (33.3%), diabetes (53.2%), depression (57.6%), and HIV infection (3.1%). 95.2% (1533/1611) of those with eGFR >60 mL/min/1.73㎡ achieved SVR. SVR rates were 96.7% in those with CKD stage 3, and 96.3% in those with CKD stages 4-5. SVR rates were 93.3-100% in participant subgroups based on HCV genotype, HIV coinfection, baseline viral load, and cirrhosis. Full SVR data will be presented at the meeting. Conclusions: EBR/GZR was highly effective in HCV-infected veterans with moderate to severe CKD. SVR rates were high across select subgroups in a large clinical setting.