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Clinical Trial
. 2023 Apr 1;18(4):485-490.
doi: 10.2215/CJN.0000000000000107. Epub 2023 Mar 1.

Early Experience with Modified Dose Nirmatrelvir/Ritonavir in Dialysis Patients with Coronavirus Disease 2019

Swapnil Hiremath  1 , Peter G Blake  2   3 , Angie Yeung  3 , Michaeline McGuinty  4 , Doneal Thomas  3 , Jane Ip  3 , Pierre Antoine Brown  1 , Michael Pandes  5 , Andrew Burke  6 , Qazi Zain Sohail  2 , Karen To  7 , Lindsay Blackwell  8 , Matthew Oliver  9 , Arsh K Jain  2 , Zain Chagla  10 , Rebecca Cooper  3   11
Affiliations
Clinical Trial

Early Experience with Modified Dose Nirmatrelvir/Ritonavir in Dialysis Patients with Coronavirus Disease 2019

Swapnil Hiremath et al. Clin J Am Soc Nephrol. .

Abstract

Background: Nirmatrelvir/ritonavir was approved for use in high-risk outpatients with coronavirus disease 2019 (COVID-19). However, patients with severe CKD were excluded from the phase 3 trial, and the drug is not recommended for those with GFR <30 ml/min per 1.73 m 2 . On the basis of available pharmacological data, we developed a modified low-dose regimen of nirmatrelvir/ritonavir 300/100 mg on day 1, followed by 150/100 mg daily from day 2 to 5. In this study, we report our experience with this modified dose regimen in dialysis patients in the Canadian province of Ontario.

Methods: We included dialysis patients who developed COVID-19 and were treated with the modified dose nirmatrelvir/ritonavir regimen during a 60-day period between April 1 and May 31, 2022. Details of nirmatrelvir/ritonavir use and outcomes were captured manually, and demographic data were obtained from a provincial database. Data are presented with descriptive statistics. The principal outcomes we describe are 30-day hospitalization, 30-day mortality, and required medication changes with the modified dose regimen.

Results: A total of 134 dialysis patients with COVID-19 received nirmatrelvir/ritonavir during the period of study. Fifty-six percent were men, and the mean age was 64 years. Most common symptoms were cough and/or sore throat (60%). Medication interactions were common with calcium channel blockers, statins being the most frequent. Most patients (128, 96%) were able to complete the course of nirmatrelvir/ritonavir, and none of the patients who received nirmatrelvir/ritonavir died of COVID-19 in the 30 days of follow-up.

Conclusions: A modified dose of nirmatrelvir/ritonavir use was found to be safe and well tolerated, with no serious adverse events being observed in a small sample of maintenance dialysis patients.

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Conflict of interest statement

L. Blackwell reports honoraria from Otsuka Canada Pharmaceutical Inc. for participating in a Renal Pharmacist Regional Advisory Board Meeting. P.G. Blake is a contracted Medical Lead at Ontario Renal Network, Ontario Health. P.G. Blake reports honoraria from Baxter Global and Otsuka Australia; an advisory or leadership role as the Medical Director of Ontario Renal Network—this is a paid role; and serving on the Editorial Board of the American Journal of Nephrology. P.A. Brown reports consultancy with Amgen Canada, AstraZeneca Canada, and Otsuka Canada; research funding from Otsuka Canada; and honoraria from AstraZeneca Canada and Otsuka Canada. Z. Chagla reports consultancy agreements with Pfizer; research funding from Gilead, Pfizer, and Roche; and speakers bureau from Gilead and Pfizer. R. Cooper, J. Ip, D. Thomas, and A. Yeung are salaried employees of Ontario Renal Network, Ontario Health. S. Hiremath reports research salary support from the Department of Medicine, University of Ottawa; serving on the Editorial Boards of the American Journal of Kidney Disease, the American Journal of Hypertension, and the Canadian Journal of Cardiology; and serving on the Board of Directors for NephJC (not-for-profit educational entity; unpaid volunteer position). A.K. Jain is a contracted Medical Lead at Ontario Renal Network, Ontario Health. A.K. Jain reports consultancy agreements with AWAK Technologies; research funding from Baxter Healthcare; honoraria from Baxter Healthcare; and an advisory or leadership role for Ontario Renal Network. M. McGuinty reports research funding from VBI. M. Oliver is a contracted Medical Lead at Ontario Renal Network and Ontario Health. He is the owner of Oliver Medical Management, Inc., which is a private corporation that licenses Dialysis Management Analysis and Reporting System software. Oliver Medical Management Inc. is the co-owner of a Canadian patent for DMAR systems. M. Oliver has received honoraria from Baxter Healthcare. M. Pandes reports honoraria from, an advisory or leadership role with, and speakers bureau for AstraZeneca. All remaining authors have nothing to disclose.

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