From the Guidelines
Paxlovid can be used in patients with chronic kidney disease (CKD), but dosage adjustments are necessary based on kidney function. For patients with moderate kidney impairment (eGFR 30-60 mL/min), the recommended dose is nirmatrelvir 150 mg (one tablet) with ritonavir 100 mg (one tablet) taken together twice daily for 5 days 1. However, the provided evidence does not directly address the use of Paxlovid in CKD patients, but it discusses the use of direct-acting antiviral (DAA) regimens in patients with CKD, which can inform the decision-making process for Paxlovid use.
Key Considerations
- The evidence suggests that some medications, like Sofosbuvir, can be used in patients with advanced CKD (G4-G5D) without dose adjustment, as recent data show that reduced renal elimination in CKD G4-G5 has limited clinical importance 1.
- However, nirmatrelvir, a component of Paxlovid, is primarily eliminated by the kidneys, and reduced kidney function may lead to drug accumulation and potential toxicity if not properly adjusted.
- Patients with severe kidney impairment (eGFR <30 mL/min) may require careful consideration, and Paxlovid is not recommended in this group due to the potential for drug accumulation and toxicity.
- Monitoring for potential drug interactions is crucial, as ritonavir inhibits CYP3A4 enzyme, which metabolizes many medications commonly used by CKD patients 1.
Dosage Adjustments
- For patients with mild kidney impairment (eGFR >60 mL/min), the standard dose of nirmatrelvir 300 mg (two tablets) with ritonavir 100 mg (one tablet) twice daily for 5 days can be used.
- For patients with moderate kidney impairment (eGFR 30-60 mL/min), the recommended dose is nirmatrelvir 150 mg (one tablet) with ritonavir 100 mg (one tablet) taken together twice daily for 5 days.
- Patients with severe kidney impairment (eGFR <30 mL/min) should avoid Paxlovid due to the risk of drug accumulation and toxicity.
Clinical Implications
- Clinicians should consult the latest guidelines from relevant organizations for the most up-to-date treatment information, as recommended drugs and dosage may change 1.
- The use of Paxlovid in CKD patients requires careful consideration of the potential benefits and risks, as well as monitoring for potential drug interactions and toxicity.
From the FDA Drug Label
PAXLOVID is not recommended in patients with severe renal impairment (eGFR <30 mL/min). Reduce the PAXLOVID dosage in patients with moderate renal impairment (eGFR ≥30 to <60 mL/min)
Paxlovid with CKD:
- Moderate Renal Impairment (eGFR ≥30 to <60 mL/min): The dosage of Paxlovid should be reduced to 150 mg nirmatrelvir with 100 mg ritonavir, taken twice daily for 5 days.
- Severe Renal Impairment (eGFR <30 mL/min): Paxlovid is not recommended for use in patients with severe renal impairment until more data are available.
- Mild Renal Impairment (eGFR ≥60 to <90 mL/min): No dosage adjustment is recommended. 2 2
From the Research
Paxlovid with CKD
- The use of Paxlovid (nirmatrelvir-ritonavir) in patients with chronic kidney disease (CKD) has been studied in several trials 3, 4, 5, 6, 7.
- A prospective, single-arm, interventional trial found that a modified dose of nirmatrelvir-ritonavir is well-tolerated in patients with CKD, including those with stage 5 CKD on dialysis, and can effectively suppress the SARS-CoV-2 viral load with a favorable safety profile 3.
- Another study discussed the pharmacokinetics and pharmacodynamics of COVID-19-related antiviral drugs, including nirmatrelvir-ritonavir, and their potential use and dosing in patients with different stages of CKD 4.
- A cohort study found that molnupiravir and nirmatrelvir/ritonavir were safe and well-tolerated in patients with advanced CKD and kidney failure, with no adverse events attributed to drug-drug interactions 5.
- A propensity score-matched study found that nirmatrelvir-ritonavir was associated with decreased risk of hospitalization within 30 days and 1-year risk of major adverse cardiovascular events and death in patients with CKD and kidney failure 6.
- A real-world cohort study found that nirmatrelvir/ritonavir was associated with a higher probability of having a negative test within 10 days from the first positive test, but also had a higher frequency of adverse events compared to other antivirals 7.
Safety and Efficacy
- The safety and efficacy of Paxlovid in patients with CKD have been evaluated in several studies, with most finding that it is well-tolerated and effective in reducing the risk of hospitalization and death 3, 5, 6.
- However, one study found that nirmatrelvir/ritonavir was associated with a higher frequency of adverse events compared to other antivirals 7.
- The use of Paxlovid in patients with CKD requires careful consideration of the potential risks and benefits, as well as close monitoring for adverse events 4, 5, 6.
Dosage and Administration
- The dosage and administration of Paxlovid in patients with CKD may need to be modified to account for reduced kidney function 3, 4.
- A modified dose of nirmatrelvir-ritonavir has been found to be well-tolerated and effective in patients with CKD, including those with stage 5 CKD on dialysis 3.
- Healthcare professionals should carefully consider the potential risks and benefits of using Paxlovid in patients with CKD, and consult with a nephrologist or other specialist as needed 4, 5, 6.