tetano
Editor, Senior Moderator
Clin J Am Soc Nephrol
. 2023 Feb 1.
doi: 10.2215/CJN.0000000000000107. Online ahead of print.
Early Experience with Modified Dose Nirmatrelvir/Ritonavir in Dialysis Patients with Coronavirus Disease 2019
Swapnil Hiremath[SUP] 1 [/SUP], Peter G Blake[SUP] 2 3 [/SUP], Angie Yeung[SUP] 3 [/SUP], Michaeline McGuinty[SUP] 4 [/SUP], Doneal Thomas[SUP] 3 [/SUP], Jane Ip[SUP] 3 [/SUP], Pierre Antoine Brown[SUP] 1 [/SUP], Michael Pandes[SUP] 5 [/SUP], Andrew Burke[SUP] 6 [/SUP], Qazi Zain Sohail[SUP] 2 [/SUP], Karen To[SUP] 7 [/SUP], Lindsay Blackwell[SUP] 8 [/SUP], Matthew Oliver[SUP] 9 [/SUP], Arsh K Jain[SUP] 2 [/SUP], Zain Chagla[SUP] 10 [/SUP], Rebecca Cooper[SUP] 3 11 [/SUP]
Affiliations
Abstract
Background: Nirmatrelvir/Ritonavir was approved for use in high risk outpatients with coronavirus disease 2019 (COVID-19). However, patients with severe chronic kidney disease, were excluded from the phase 3 trial, and the drug is not recommended for those with a glomerular filtration rate < 30 ml/min/1.73m2. Based on available pharmacological data, we developed a modified low dose regimen of nirmatrelvir/ritonavir 300/100 mg on day one, followed by 150/100 mg daily from day two to five. 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: 134 dialysis patients with COVID-19 received nirmatrelvir/ritonavir during the period of study. 56% 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 and 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 in terms of no serious adverse events being observed in a small sample of maintenance dialysis patients.
. 2023 Feb 1.
doi: 10.2215/CJN.0000000000000107. Online ahead of print.
Early Experience with Modified Dose Nirmatrelvir/Ritonavir in Dialysis Patients with Coronavirus Disease 2019
Swapnil Hiremath[SUP] 1 [/SUP], Peter G Blake[SUP] 2 3 [/SUP], Angie Yeung[SUP] 3 [/SUP], Michaeline McGuinty[SUP] 4 [/SUP], Doneal Thomas[SUP] 3 [/SUP], Jane Ip[SUP] 3 [/SUP], Pierre Antoine Brown[SUP] 1 [/SUP], Michael Pandes[SUP] 5 [/SUP], Andrew Burke[SUP] 6 [/SUP], Qazi Zain Sohail[SUP] 2 [/SUP], Karen To[SUP] 7 [/SUP], Lindsay Blackwell[SUP] 8 [/SUP], Matthew Oliver[SUP] 9 [/SUP], Arsh K Jain[SUP] 2 [/SUP], Zain Chagla[SUP] 10 [/SUP], Rebecca Cooper[SUP] 3 11 [/SUP]
Affiliations
- PMID: 36723285
- DOI: 10.2215/CJN.0000000000000107
Abstract
Background: Nirmatrelvir/Ritonavir was approved for use in high risk outpatients with coronavirus disease 2019 (COVID-19). However, patients with severe chronic kidney disease, were excluded from the phase 3 trial, and the drug is not recommended for those with a glomerular filtration rate < 30 ml/min/1.73m2. Based on available pharmacological data, we developed a modified low dose regimen of nirmatrelvir/ritonavir 300/100 mg on day one, followed by 150/100 mg daily from day two to five. 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: 134 dialysis patients with COVID-19 received nirmatrelvir/ritonavir during the period of study. 56% 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 and 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 in terms of no serious adverse events being observed in a small sample of maintenance dialysis patients.