Abstract
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.
Highlights
Www.nature.com/scientificreports higher than those in patients receiving peritoneal dialysis[5]
In contrast to SOF-based direct acting antiviral agents (DAAs) which undergo extensive renal excretion, the combination of NS3 protease inhibitor (PI) with NS5A inhibitor is appealing to practitioners in the care of HCV among patients receiving hemodialysis because both agents are mainly metabolized by the liver[11,12]
Our study demonstrated that the sustained virologic response (SVR) at week 12 off-therapy (SVR12) rate of EBR/GZR for 12 weeks was excellent (95%) for East-Asian HCV GT1b patients receiving hemodialysis by ITT analysis
Summary
Www.nature.com/scientificreports higher than those in patients receiving peritoneal dialysis[5]. In phase III C-SURFER trial which evaluated the performance of EBR/GZR for 12 weeks for HCV GT1 patients with chronic kidney disease (CKD) stage 4 or 5, the SVR at week 12 off-therapy (SVR12) rate was 99%. Following the encouraging results from the phase III trial, the real-world studies from France and Japan evaluating the effectiveness of EBR/GZR for 12 weeks in HCV GT1b patients receiving hemodialysis showed that the SVR12 rates ranged from 95–100%14–17. These studies were retrospective in nature with sample sizes of around 20 patients with HCV GT1b infection, who are prevalent in hemodialysis units of East-Asia. We aimed to conduct a clinical trial to assess the performance of EBR/GZR for 12 weeks in HCV GT1b patients receiving hemodialysis in Taiwan
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