BACKGROUND & AIMS Randomized controlled trials of EBR/GZR have reported high treatment efficacy, safety and tolerability in patients undergoing dialysis. However, real world effectiveness data for EBR/GZR in this population is lacking. We evaluated the effectiveness of EBR/GZR in an HCV-infected population with all stages of CKD including dialysis compared with control patients with estimated glomerular filtration rate (eGFR) ≥60 in the US Department of Veterans Affairs (VA). METHODS We conducted a retrospective cohort study of patients with chronic HCV genotype 1 infection with EBR/GZR prescriptions dispensed during February 1, 2016-August 31, 2017 in 128 VA Medical Centers. We collected patient information regarding history of dialysis, end stage renal disease (ESRD), and/or eGFR values. We measured SVR based on undetectable HCV RNA at least 4 weeks after the completion of treatment. We examined SVR rates by CKD stage compared to control patients and within patient subgroups using logistic regression models. RESULTS We identified 5961 patients (42.5% genotype 1a, 55.0% genotype 1b) who met eligibility criteria and completed a EBR/GZR treatment course (≥11 weeks). Approximately 73.2% (n = 4361) had eGFR ≥60 who served as control patients, 14.4% (n = 860) had Stage 3 CKD, and 12.4% (n = 740) had Stage 4-5 CKD or ESRD. Of patients with Stage 4-5 CKD/ESRD, 76.1% underwent dialysis (n = 563). The overall SVR was 96.7% in all patients, 96.4% for eGFR≥60, 98.3% in Stage 3 CKD, and 96.5% in Stage 4-5 CKD/ESRD. No statistically significant differences were found in the SVR rates in patients with or without dialysis in the Stage 4-5 CKD/ESRD patients (adjusted OR 0.91; 95% CI 0.56-1.47 and OR 1.74; 95% CI 0.63-4.81) compared with those with eGFR≥60. CONCLUSION We found EBR/GZR was effective in patients with HCV GT1 infection regardless of CKD severity or receipt of dialysis in the US VA population.

中文翻译：

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Elbasvir/Grazoprevir 对美国退伍军人中丙型肝炎病毒基因 1 型感染和慢性肾病患者的疗效。

背景和目的 EBR/GZR 的随机对照试验报告了在接受透析的患者中的高治疗效果、安全性和耐受性。然而，缺乏该人群中 EBR/GZR 的真实世界有效性数据。我们与美国退伍军人事务部 (VA) 估计肾小球滤过率 (eGFR) ≥60 的对照患者相比，评估了 EBR/GZR 在包括透析在内的所有 CKD 阶段的 HCV 感染人群中的有效性。方法 我们对 2016 年 2 月 1 日至 2017 年 8 月 31 日期间在 128 个 VA 医疗中心开具 EBR/GZR 处方的慢性 HCV 基因型 1 感染患者进行了一项回顾性队列研究。我们收集了有关透析史、终末期肾病 (ESRD) 和/或 eGFR 值的患者信息。我们在治疗完成后至少 4 周根据无法检测到的 HCV RNA 测量 SVR。我们使用逻辑回归模型检查了 CKD 分期与对照患者和患者亚组内的 SVR 率。结果 我们确定了 5961 名患者（42.5% 基因型 1a，55.0% 基因型 1b）符合资格标准并完成了 EBR/GZR 疗程（≥11 周）。作为对照患者，大约 73.2% (n = 4361) 的 eGFR ≥60，14.4% (n = 860) 患有 3 期 CKD，12.4% (n = 740) 患有 4-5 期 CKD 或 ESRD。在 4-5 期 CKD/ESRD 患者中，76.1% 接受了透析（n = 563）。所有患者的总体 SVR 为 96.7%，eGFR≥60 为 96.4%，CKD 3 期为 98.3%，CKD/ESRD 4-5 期为 96.5%。与 4-5 期 CKD/ESRD 患者（调整后的 OR 0.91；95% CI 0.56-1.47 和 OR 1.74；95% CI 0.63-4.81）相比，接受或不接受透析的患者的 SVR 率无统计学差异。 eGFR≥60者。结论 我们发现 EBR/GZR 对 HCV GT1 感染患者有效，无论 CKD 严重程度或美国 VA 人群是否接受透析。