Prescribing Nirmatrelvir/Ritonavir for COVID-19 in Advanced CKD

Hiremath, Swapnil; McGuinty, Michaeline; Argyropoulos, Christos; Brimble, K. Scott; Brown, Pierre Antoine; Chagla, Zain; Cooper, Rebecca; Hoar, Stephanie; Juurlink, David N.; Treleaven, Darin; Walsh, Michael; Yeung, Angie; Blake, Peter G.

doi:10.2215/cjn.05270522

Cited by 42 publications

(33 citation statements)

References 8 publications

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“…These recommendations exclude major high-risk groups from therapy with Paxlovid®. Facing this dilemma, special treatment courses for patients on dialysis and with severe renal impairment have been developed [6] . A further increase in safety and effectiveness of Paxlovid® in the treatment of these special patient groups may be achieved by therapeutic drug monitoring (TDM) of nirmatrelvir and ritonavir.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous quantification of nirmatrelvir and ritonavir by LC-MS/MS in patients treated for COVID-19

Martens‐Lobenhoffer

Böger

Kielstein

et al. 2022

Journal of Chromatography B

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Section: Introductionmentioning

confidence: 99%

Simultaneous quantification of nirmatrelvir and ritonavir by LC-MS/MS in patients treated for COVID-19

Martens‐Lobenhoffer

Böger

Kielstein

et al. 2022

Journal of Chromatography B

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“…In addition, nirmatrelvir plus ritonavir (paxlovid) demonstrated efficacy in reducing both hospitalization and mortality among non-hospitalized adults with mild-to-moderate COVID-19 who were at high risk for progression to severe COVID-19, but dialysis patients were excluded; given theoretical concerns about drug accumulation and safety, the drug is not recommended for those with eGFR < 30 ml per minute [ 11 , 12 ]. Nonetheless, a small case series of 15 dialysis patients with COVID-19 treated with lower doses of nirmatrelvir/ritonavir reported rapid symptom resolution with no adverse events [ 13 ].…”

Section: Introductionmentioning

confidence: 99%

Sotrovimab in SARS-COV-2 chronic hemodialysis patients in the Omicron era. Is intradialytic administration feasible? Report of 4 cases

et al. 2022

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Chronic hemodialysis patients are at high risk of morbidity and mortality in case of SARS-CoV-2 infection and they may need to be treated with monoclonal antibodies, either because they have not been vaccinated, or because they have a low anti spike antibody titer. Administration of Sotrovimab has recently been proposed for hemodialysis patients, but data are on the results lacking. We report on four cases of chronic dialysis patients who received Sotrovimab during intermittent dialysis sessions. In our series, no adverse reactions were recorded; intradialytic administration resulted safe and allowed an adequate observation time without prolonging hospital stay in chronic hemodialysis outpatients.

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“…[5][6][7] Dose adjustments have been proposed and a recent case series investigated a dose of 300/100 mg N/r on day one, followed by 150/100 mg once daily from day two to five in ESRD patients, yet, without pharmacokinetic measurements. 8,9 Additional assessment of the pharmacokinetic behaviour of N/r in patients with ESRD on chronic intermittent HD is therefore of particular interest for clinicians, especially because of the increased risk of a severe course of COVID-19 in these patients. 7,10,11 Herein we report data on pharmacokinetics and hepatic tolerance of nirmatrelvir and ritonavir treatment in four ESRD patients on intermittent HD with COVID-19.…”

Section: Introductionmentioning

confidence: 99%

“…5-7 Dose adjustments have been proposed and a recent case series investigated a dose of 300/100 mg N/r on day one, followed by 150/100 mg once daily from day two to five in ESRD patients, yet, without pharmacokinetic measurements. 8,9…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics of nirmatrelvir and ritonavir in COVID-19 patients with end stage renal disease on intermittent haemodialysis

Lingscheid

Kinzig

Krüger

et al. 2022

Preprint

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Background: Nirmatrelvir/ritonavir is an effective therapy against SARS-CoV-2. Patients with end-stage renal disease (ESRD) are at high risk for severe COVID-19 and show impaired vaccine responses underlining the importance of antiviral therapy. However, use of nirmatrelvir/ritonavir is not recommended in these patients due to lack of clinical and pharmacokinetic data. Objective: To investigate pharmacokinetics and hepatic tolerance of nirmatrelvir/ritonavir in patients with ESRD and haemodialysis (HD). Patients and methods: Four patients diagnosed with SARS-CoV-2 infection received nirmatrelvir/ritonavir 150/100mg twice daily as recommended for renal impairment; HD ran in two- to three-day intervals. Plasma and serum samples were drawn before and after each HD during the 5-day treatment and for ensuing 3-5 days. Results: Median peak levels of nirmatrelvir obtained two hours after medication pre-HD in three patients were 7745ng/mL on day 3 and 6653ng/mL on day 5; median post-HD levels (C6h) declined to 5765ng/mL (74%) and 5521ng/mL (83%), on days 3 and 5 of treatment, respectively. Three days after end of treatment, median levels were 365ng/mL pre-HD and 30ng/mL post-HD. Measurements of the fourth patient, six hours after drug intake pre-HD showed nirmatrelvir-levels of 3704ng/mL on treatment day 3 which fell to 2308ng/mL post-HD, at one hour before intake of the next dose (Cmin). Conclusion: Use of nirmatrelvir/ritonavir in patients with ESRD results in high nirmatrelvir blood concentrations, which are still within the range known from patients without renal failure. No accumulation of nirmatrelvir took place and levels declined to zero within few days after end of treatment.

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Prescribing Nirmatrelvir/Ritonavir for COVID-19 in Advanced CKD

Cited by 42 publications

References 8 publications

Simultaneous quantification of nirmatrelvir and ritonavir by LC-MS/MS in patients treated for COVID-19

Simultaneous quantification of nirmatrelvir and ritonavir by LC-MS/MS in patients treated for COVID-19

Sotrovimab in SARS-COV-2 chronic hemodialysis patients in the Omicron era. Is intradialytic administration feasible? Report of 4 cases

Pharmacokinetics of nirmatrelvir and ritonavir in COVID-19 patients with end stage renal disease on intermittent haemodialysis

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