Department of Pharmacy, University of Chicago Medicine, Chicago, Illinois, USA.
Department of Medicine, Section of Infectious Diseases and Global Health, University of Chicago Medicine, Chicago, Illinois, USA.
Clin Infect Dis. 2021 Dec 6;73(11):e3990-e3995. doi: 10.1093/cid/ciaa1851.
Remdesivir (RDV) is US FDA approved for coronavirus disease 2019 (COVID-19) but not recommended in severe renal impairment (SRI, Creatinine clearance <30mL/min or requiring renal replacement therapy). Few studies have evaluated RDV in patients with SRI.
Hospitalized patients who received RDV between 1 May 2020 and 31 October 2020 were analyzed in a retrospective chart review. We compared incident adverse events (AEs) in patients with and without SRI, including hepatotoxicity, nephrotoxicity, any reported AE, mortality, and length of stay.
Of a total of 135 patients, 20 had SRI. Patients with SRI were significantly older (70 vs 54 years, P = .0001). The incidence of possible AEs was 30% among those with SRI vs 11% without (P = .06). Liver function test (LFT) elevations occurred in 10% vs 4% (P = .28), and serum creatinine (SCr) elevations in 27% vs 6% (P = .02) of patients with SRI vs without, respectively. LFT and SCr elevations were not attributed to RDV in either group. Mortality and length of stay were consistent with historical controls.
RDV AEs occurred infrequently and overall were not significantly different between those with and without SRI. While more of patients with SRI experienced SCr elevations, 3 (75%) patients had acute kidney injury prior to RDV. The use of RDV in this small series of patients with SRI appeared to be relatively safe, and the potential benefit outweighed the theoretical risk of liver or renal toxicity. Additional studies are needed to confirm this finding.
瑞德西韦(RDV)已获得美国食品药品监督管理局(FDA)批准用于治疗 2019 冠状病毒病(COVID-19),但不适用于严重肾功能损害(SRI,肌酐清除率<30ml/min 或需要肾脏替代治疗)患者。仅有少数研究评估了 RDV 在 SRI 患者中的应用。
本回顾性图表分析纳入了 2020 年 5 月 1 日至 10 月 31 日期间接受 RDV 治疗的住院患者。我们比较了 SRI 患者与非 SRI 患者的不良事件(AE)发生率,包括肝毒性、肾毒性、任何报告的 AE、死亡率和住院时间。
共纳入 135 例患者,其中 20 例患者存在 SRI。SRI 患者年龄显著大于非 SRI 患者(70 岁 vs 54 岁,P=0.0001)。SRI 患者的可能 AE 发生率为 30%,而非 SRI 患者为 11%(P=0.06)。SRI 患者中发生肝功能检查(LFT)升高的比例为 10%,而非 SRI 患者为 4%(P=0.28),血清肌酐(SCr)升高的比例为 27%,而非 SRI 患者为 6%(P=0.02)。两组中 LFT 和 SCr 升高均与 RDV 无关。两组患者的死亡率和住院时间相似。
RDV 的 AE 发生率较低,且在 SRI 患者与非 SRI 患者之间总体无显著差异。虽然更多的 SRI 患者发生了 SCr 升高,但在接受 RDV 治疗前,3(75%)例患者已有急性肾损伤。本研究中 SRI 患者使用 RDV 相对安全,潜在获益超过肝毒性或肾毒性的理论风险。需要进一步研究证实这一发现。