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Early Experience with Modified Dose Nirmatrelvir/Ritonavir in Dialysis Patients with Coronavirus Disease 2019
Swapnil Hiremath1, Peter G Blake2,3, Angie Yeung3
1Division of Nephrology, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Insights
A modified low-dose nirmatrelvir/ritonavir regimen was safe and effective for dialysis patients with COVID-19. This approach allowed completion of treatment with no 30-day mortality observed in the study cohort.
Area of Science:
- Nephrology
- Infectious Diseases
- Pharmacology
Background:
- Nirmatrelvir/ritonavir is approved for high-risk COVID-19 outpatients.
- Severe CKD patients were excluded from trials; use is not recommended for GFR <30 ml/min.
- A modified low-dose regimen was developed based on pharmacological data.
Purpose of the Study:
- To evaluate the safety and efficacy of a modified low-dose nirmatrelvir/ritonavir regimen.
- To assess outcomes in maintenance dialysis patients with COVID-19 treated with the modified regimen.
Main Methods:
- Retrospective study of 134 dialysis patients treated between April 1 and May 31, 2022.
- Data collected on nirmatrelvir/ritonavir use, outcomes, and demographics.
- Principal outcomes: 30-day hospitalization, 30-day mortality, and medication changes.
Main Results:
- 134 dialysis patients received the modified regimen; 96% completed treatment.
- Common symptoms included cough and sore throat (60%).
- No 30-day mortality due to COVID-19 was observed.
Conclusions:
- Modified-dose nirmatrelvir/ritonavir was safe and well-tolerated in maintenance dialysis patients.
- No serious adverse events were reported.
- The regimen facilitated treatment completion in this vulnerable population.
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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