TY  - JOUR
PY  - 2020//
TI  - Elbasvir/grazoprevir for hepatitis C virus genotype 1b East-Asian patients receiving hemodialysis
JO  - Scientific reports
A1  - Liu, Chen-Hua
A1  - Peng, Cheng-Yuan
A1  - Fang, Yu-Jen
A1  - Kao, Wei-Yu
A1  - Yang, Sheng-Shun
A1  - Lin, Cheng-Kuan
A1  - Lai, Hsueh-Chou
A1  - Su, Wen-Pang
A1  - Fang, Sheng-Uei
A1  - Chang, Chun-Chao
A1  - Su, Tung-Hung
A1  - Liu, Chun-Jen
A1  - Chen, Pei-Jer
A1  - Chen, Ding-Shinn
A1  - Kao, Jia-Horng
SP  - e9180
EP  - e9180
VL  - 10
IS  - 1
N2  - Data regarding the efficacy and tolerability of elbasvir/grazoprevir (EBR/GZR) for East-Asian hepatitis C virus genotype 1b (HCV GT1b) patients receiving hemodialysis were limited. We prospectively recruited 40 HCV GT1b hemodialysis patients who received EBR/GZR for 12 weeks at 6 academic centers in Taiwan. The efficacy endpoints were sustained virologic response 12 weeks off-therapy (SVR12) by intention-to-treat (ITT) modified ITT (mITT) analyses. Patients' baseline characteristics, early viral kinetics and HCV resistance-associated substitutions (RASs) at HCV non-structural 3 and 5 A (NS3 and NS5A) regions potentially affecting SVR12 were analyzed. The tolerability for EBR/GZR was also assessed. The SVR12 rates by ITT and mITT analyses were 95% (38 of 40 patients; 95% confidence interval (CI): 83.5-98.6%) and 100% (38 of 38 patients; 95% CI: 90.8-100%), respectively. Patients' baseline characteristics, on-treatment viral decline, and baseline HCV RASs did not affect SVR12. All patients tolerated treatment well. Among 5 patients who had serious adverse events (AEs) including one death due to on-treatment suicide and the other death due to off-therapy acute myocardial infarction, none of these events were judged related to EBR/GZR. The common AEs included upper respiratory tract infection (7.5%), fatigue (5.0%) and anorexia (5.0%). Nine (22.5%) and 8 (20.0%) patients had on-treatment hemoglobin levels of 9.0-10.0 g/dL and 7.0-9.0 g/dL. Three (7.5%) patients had on-treatment elevated alanine aminotransferase (ALT) quotient > 2.5, in whom one (2.5%) had EBR/GZR-induced late ALT elevation. No patients developed hyperbilirubinemia or hepatic decompensation. In conclusion, treatment with EBR/GZR is effective and well-tolerated for East-Asian HCV GT1b patients receiving hemodialysis.<p /> <p>Language: en</p>
LA  - en
SN  - 2045-2322
UR  - http://dx.doi.org/10.1038/s41598-020-66182-8
ID  - ref1
ER  -