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Is Nirmaltrevir-Ritonavir (Paxlovid) Safe for CKD or Dialysis Patients?

September 25, 2023

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Written by Laura Murphy

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Modified dose nirmaltrevir-ritonavir is well-tolerated in patients with CKD as therapy for mild COVID-19 and effectively suppresses viral load.

Avoiding “renalism” when treating patients with mild COVID-19
Patients with chronic kidney disease (CKD), particularly patients on dialysis, are at higher risk of progression to severe COVID-19. However, most trials for antiviral treatment with nirmaltrevir-ritonavir excluded patients with CKD, and antiviral therapy has not been recommended for patients with eGFR< 30 mL/min/1.75 m2.

This was a prospective, single-arm interventional study that recruited patients with mild COVID-19 and eGFR <60 mL/min/1.73 m2. Ten patients with eGFR>60 were recruited as controls. Patients were divided into high GFR (eGFR>30 mL/min/1.73 m2 , n=20) and low GFR (eGFR<30 mL/min/1.73 m2, n=65); the majority of patients had stage 5 CKD and were on dialysis (n=59 or 69.4%). Patients received modified nirmaltrevir-ritonavir dosing based on eGFR*.  Of patients with eGFR<60 mL/min/1.73 m2, 9.4% experienced adverse events (most reported gastrointestinal symptoms). 5.9% experienced severe adverse events (i.e. severe COVID-19 pneumonia), which were not related to the drug. Rates of adverse events were comparable between patients with eGFR greater than or less than 30 mL/min/1.73 m2. The viral load was significantly decreased on days 5, 15, and 30 for all groups (regardless of eGFR), and ten patients (11.8%) had virologic rebound (largely in dialysis patients).

A major limitation of this study is its small sample size, and additional studies are likely needed to further determine optimal dosing for patients with advanced CKD. However, in addition to other pharmacokinetics this study suggests that modified dose nirmaltrevir-ritonavir to treat mild COVID-19 is likely safe in patients with advanced CKD. 

How will this change my practice?
Based on this and other pharmacokinetic studies, I will consider modified dosing regimens for nirmaltrevir-ritonavir for patients with CKD and mild COVID-19, including patients with eGFR<30 mL/min/1.73 m2.

*Most common dosing was: nirmatrelvir 300mg/ ritonavir 100mg once on day 1 | nirmatrelvir 150mg/ ritonavir 100mg once daily on days 2-5 if eGFR <30 or on dialysis (PD or HD).

Safety Profile and Clinical and Virological Outcomes of Nirmatrelvir-Ritonavir Treatment in Patients With Advanced Chronic Kidney Disease and Coronavirus Disease 2019 (COVID-19). Clin Infect Dis. 2023 Aug 2:ciad371. doi: 10.1093/cid/ciad371. Epub ahead of print.

What are your thoughts?