A Valid Warning or Clinical Lore: an Evaluation of Safety Outcomes of Remdesivir in Patients with Impaired Renal Function from a Multicenter Matched Cohort

被引:45
作者
Ackley, Tyler W. [1 ]
McManus, Dayna [1 ]
Topal, Jeffrey E. [1 ,2 ]
Cicali, Brian [3 ]
Shah, Sunish [1 ,4 ]
机构
[1] Yale New Haven Hlth Syst, Dept Pharm, New Haven, CT 06519 USA
[2] Yale Univ, Sch Med, Dept Internal Med, Sect Infect Dis, New Haven, CT 06510 USA
[3] Univ Florida, Coll Pharm, Dept Pharmaceut, Ctr Pharmacometr & Syst Pharmacol, Orlando, FL USA
[4] Univ Pittsburgh, Dept Pharm, Med Ctr, Pittsburgh, PA 15213 USA
关键词
COVID; SARS-CoV-2; SBECD; chronic kidney disease; remdesivir; renal failure; CYCLODEXTRIN; VORICONAZOLE; PREDICTION; CREATININE;
D O I
10.1128/AAC.02290-20
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
Per prescribing guidance, remdesivir is not recommended for SARSCoV-2 in patients with renal disease given the absence of safety data in this patient population. This study was a multicenter, retrospective chart review of hospitalized patients with SARS-CoV-2 who received remdesivir. Safety outcomes were compared between patients with an estimated creatinine clearance (eCrCl) of <30 ml/min and an eCrCl of >= 30 ml/min. The primary endpoint was acute kidney injury (AKI) at the end of treatment (EOT). Of 359 patients who received remdesivir, 347 met inclusion criteria. Patients with an eCrCl of <30 ml/min were older {median, 80 years (interquartile range [IQR], 63.8 to 89) versus 62 (IQR, 54 to 74); P<0.001}, were more likely to be on vasopressors on the day of remdesivir administration (30% versus 12.7%; P = 0.003), and were more likely to be mechanically ventilated during remdesivir therapy (27.5% versus 12.4%; P = 0.01) than those with an eCrCl of <30 ml/min. Despite these confounders, there was no significant difference in the frequency of EOT AKI (5% versus 2.3%; P = 0.283) or early discontinuation due to abnormal liver function tests (LFTs) (0% versus 3.9%; P = 0.374). Of the 5% of patients who developed EOT AKI on remdesivir with an eCrCl <30 ml/min, no cases were attributable to remdesivir administration per the treating physician. Comparable safety outcomes were observed when 1:1 nearest neighbor matching was applied to account for baseline confounders. In conclusion, remdesivir administration was not significantly associated with increased EOT AKI in patients with an eCrCl of <30 ml/min compared to patients with an eCrCl of >= 30 ml/min.
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共 29 条
  • [1] Acute Kidney Injury in COVID-19: Emerging Evidence of a Distinct Pathophysiology
    Batlle, Daniel
    Soler, Maria Jose
    Sparks, Matthew A.
    Hiremath, Swapnil
    South, Andrew M.
    Welling, Paul A.
    Swaminathan, Sundararaman
    [J]. JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY, 2020, 31 (07): : 1380 - 1383
  • [2] Remdesivir for the Treatment of Covid-19-Final Report
    Beigel, John H.
    Tomashek, Kay M.
    Dodd, Lori E.
    Mehta, Aneesh K.
    Zingman, Barry S.
    Kalil, Andre C.
    Hohmann, Elizabeth
    Chu, Helen Y.
    Luetkemeyer, Annie
    Kline, Susan
    de Castilla, Diego Lopez
    Finberg, Robert W.
    Dierberg, Kerry
    Tapson, Victor
    Hsieh, Lanny
    Patterson, Thomas F.
    Paredes, Roger
    Sweeney, Daniel A.
    Short, William R.
    Touloumi, Giota
    Lye, David Chien
    Ohmagari, Norio
    Oh, Myoung-don
    Ruiz-Palacios, Guillermo M.
    Benfield, Thomas
    Faetkenheuer, Gerd
    Kortepeter, Mark G.
    Atmar, Robert L.
    Creech, C. Buddy
    Lundgren, Jens
    Babiker, Abdel G.
    Pett, Sarah
    Neaton, James D.
    Burgess, Timothy H.
    Bonnett, Tyler
    Green, Michelle
    Makowski, Mat
    Osinusi, Anu
    Nayak, Seema
    Lane, H. Clifford
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2020, 383 (19) : 1813 - 1826
  • [3] Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group
    Bellomo, R
    Ronco, C
    Kellum, JA
    Mehta, RL
    Palevsky, P
    [J]. CRITICAL CARE, 2004, 8 (04): : R204 - R212
  • [4] Bilal M, 2020, PHARMACOKINETICS REM, DOI [10.1101/2020.10.28.20216887v1.full., DOI 10.1101/2020.10.28.20216887V1.FULL.]
  • [5] Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study
    Chen, Nanshan
    Zhou, Min
    Dong, Xuan
    Qu, Jieming
    Gong, Fengyun
    Han, Yang
    Qiu, Yang
    Wang, Jingli
    Liu, Ying
    Wei, Yuan
    Xia, Jia'an
    Yu, Ting
    Zhang, Xinxin
    Zhang, Li
    [J]. LANCET, 2020, 395 (10223) : 507 - 513
  • [6] PREDICTION OF CREATININE CLEARANCE FROM SERUM CREATININE
    COCKCROFT, DW
    GAULT, MH
    [J]. NEPHRON, 1976, 16 (01) : 31 - 41
  • [7] Remdesivir and GS-441524 plasma concentrations in patients with end-stage renal disease on haemodialysis
    Davis, Matthew R.
    Pham, Christine U.
    Cies, Jeffrey J.
    [J]. JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY, 2021, 76 (03) : 822 - 825
  • [8] That Escalated Quickly: Remdesivir's Place in Therapy for COVID-19
    Davis, Matthew R.
    McCreary, Erin K.
    Pogue, Jason M.
    [J]. INFECTIOUS DISEASES AND THERAPY, 2020, 9 (03) : 525 - 536
  • [9] European Medicines Agency, 2020, ANN PRESCR INF REMD
  • [10] FRANK DW, 1976, AM J PATHOL, V83, P367