New algorithm for valganciclovir dosing in pediatric solid organ transplant recipients
CMV infections are common after SOT. v‐GCV is increasingly used in children. The aim of this study was to evaluate presently used dosing algorithms. Data from 104 pediatric SOT recipients (kidney, liver, and heart) aged 0.3–16.9 yr and receiving v‐GCV once a day were used for model development and v...
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Published in | Pediatric transplantation Vol. 18; no. 1; pp. 103 - 111 |
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Main Authors | , , |
Format | Journal Article |
Language | English |
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Blackwell Publishing Ltd
01.02.2014
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Abstract | CMV infections are common after SOT. v‐GCV is increasingly used in children. The aim of this study was to evaluate presently used dosing algorithms. Data from 104 pediatric SOT recipients (kidney, liver, and heart) aged 0.3–16.9 yr and receiving v‐GCV once a day were used for model development and validation with the Pmetrics package for R. Monte Carlo simulations were performed to compare the probability of a GCV AUC 40–60 mg*h/L with the different algorithms across a range of ages, weights, and GFRs. GCV pharmacokinetics was well described by the non‐parametric model. Clearance was dependent on GFR and Cockcroft‐Gault estimates improved the model fit over Schwartz. Simulations showed that our new algorithm, where v‐GCV dose is: Weight [kg]*(0.07*GFR [mL/min]+k), where k = 5 for GFR ≤ 30 mL/min, k = 10 for GFR > 30 mL/min and weight > 30 kg and k = 15 for GFR > 30 mL/min and weight ≤ 30 kg, outperformed the other algorithms. Thirty‐three percent of all patients achieve an exposure above and 21% within the therapeutic window. We propose a simple algorithm for initial v‐GCV dosing that standardizes plasma drug exposure better than current algorithms. Subsequent TDM is strongly suggested to achieve individual drug levels within the therapeutic window. |
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AbstractList | CMV infections are common after SOT. v-GCV is increasingly used in children. The aim of this study was to evaluate presently used dosing algorithms. Data from 104 pediatric SOT recipients (kidney, liver, and heart) aged 0.3–16.9 yr and receiving v-GCV once a day were used for model development and validation with the Pmetrics package for R. Monte Carlo simulations were performed to compare the probability of a GCV AUC 40–60 mg*h/L with the different algorithms across a range of ages, weights, and GFRs. GCV pharmacokinetics was well described by the non-parametric model. Clearance was dependent on GFR and Cockcroft-Gault estimates improved the model fit over Schwartz. Simulations showed that our new algorithm, where v-GCV dose is: Weight [kg]*(0.07*GFR [mL/min]+
k
), where
k
= 5 for GFR ≤ 30 mL/min,
k
= 10 for GFR > 30 mL/min and weight > 30 kg and
k
= 15 for GFR > 30 mL/min and weight ≤ 30 kg, outperformed the other algorithms. Thirty-three percent of all patients achieve an exposure above and 21% within the therapeutic window. We propose a simple algorithm for initial v-GCV dosing that standardizes plasma drug exposure better than current algorithms. Subsequent TDM is strongly suggested to achieve individual drug levels within the therapeutic window. Abstract CMV infections are common after SOT . v‐ GCV is increasingly used in children. The aim of this study was to evaluate presently used dosing algorithms. Data from 104 pediatric SOT recipients (kidney, liver, and heart) aged 0.3–16.9 yr and receiving v‐ GCV once a day were used for model development and validation with the Pmetrics package for R. Monte Carlo simulations were performed to compare the probability of a GCV AUC 40–60 mg*h/L with the different algorithms across a range of ages, weights, and GFR s. GCV pharmacokinetics was well described by the non‐parametric model. Clearance was dependent on GFR and Cockcroft‐Gault estimates improved the model fit over Schwartz. Simulations showed that our new algorithm, where v‐GCV dose is: Weight [kg]*(0.07*GFR [mL/min]+ k ), where k = 5 for GFR ≤ 30 mL/min, k = 10 for GFR > 30 mL/min and weight > 30 kg and k = 15 for GFR > 30 mL/min and weight ≤ 30 kg, outperformed the other algorithms. Thirty‐three percent of all patients achieve an exposure above and 21% within the therapeutic window. We propose a simple algorithm for initial v‐ GCV dosing that standardizes plasma drug exposure better than current algorithms. Subsequent TDM is strongly suggested to achieve individual drug levels within the therapeutic window. CMV infections are common after SOT. v-GCV is increasingly used in children. The aim of this study was to evaluate presently used dosing algorithms. Data from 104 pediatric SOT recipients (kidney, liver, and heart) aged 0.3-16.9 yr and receiving v-GCV once a day were used for model development and validation with the Pmetrics package for R. Monte Carlo simulations were performed to compare the probability of a GCV AUC 40-60 mg*h/L with the different algorithms across a range of ages, weights, and GFRs. GCV pharmacokinetics was well described by the non-parametric model. Clearance was dependent on GFR and Cockcroft-Gault estimates improved the model fit over Schwartz. Simulations showed that our new algorithm, where v-GCV dose is: Weight [kg]*(0.07*GFR [mL/min]+k), where k = 5 for GFR ≤ 30 mL/min, k = 10 for GFR > 30 mL/min and weight > 30 kg and k = 15 for GFR > 30 mL/min and weight ≤ 30 kg, outperformed the other algorithms. Thirty-three percent of all patients achieve an exposure above and 21% within the therapeutic window. We propose a simple algorithm for initial v-GCV dosing that standardizes plasma drug exposure better than current algorithms. Subsequent TDM is strongly suggested to achieve individual drug levels within the therapeutic window. CMV infections are common after SOT. v‐GCV is increasingly used in children. The aim of this study was to evaluate presently used dosing algorithms. Data from 104 pediatric SOT recipients (kidney, liver, and heart) aged 0.3–16.9 yr and receiving v‐GCV once a day were used for model development and validation with the Pmetrics package for R. Monte Carlo simulations were performed to compare the probability of a GCV AUC 40–60 mg*h/L with the different algorithms across a range of ages, weights, and GFRs. GCV pharmacokinetics was well described by the non‐parametric model. Clearance was dependent on GFR and Cockcroft‐Gault estimates improved the model fit over Schwartz. Simulations showed that our new algorithm, where v‐GCV dose is: Weight [kg]*(0.07*GFR [mL/min]+k), where k = 5 for GFR ≤ 30 mL/min, k = 10 for GFR > 30 mL/min and weight > 30 kg and k = 15 for GFR > 30 mL/min and weight ≤ 30 kg, outperformed the other algorithms. Thirty‐three percent of all patients achieve an exposure above and 21% within the therapeutic window. We propose a simple algorithm for initial v‐GCV dosing that standardizes plasma drug exposure better than current algorithms. Subsequent TDM is strongly suggested to achieve individual drug levels within the therapeutic window. |
Author | Åsberg, A. Neely, M. Bjerre, A. |
Author_xml | – sequence: 1 givenname: A. surname: Åsberg fullname: Åsberg, A. email: Prof. Anders Åsberg, Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo, P.O. Box 1068, Blindern, 0316 Oslo, NorwayTel.: +47 22 85 65 59Fax: +47 22 85 44 02, anders.asberg@farmasi.uio.no organization: Department of Pharmaceutical Biosciences, School of Pharmacy, University of Oslo, Oslo, Norway – sequence: 2 givenname: A. surname: Bjerre fullname: Bjerre, A. organization: Department of Pediatrics, Oslo University Hospital-Rikshospitalet, Oslo, Norway – sequence: 3 givenname: M. surname: Neely fullname: Neely, M. organization: Laboratory of Applied Pharmacokinetics, University of Southern California, CA, Los Angeles, USA |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/24152053$$D View this record in MEDLINE/PubMed |
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Keywords | valganciclovir population model solid organ transplantation pediatric transplantation cytomegalovirus therapeutic drug monitoring |
Language | English |
License | Attribution-NonCommercial 2013 The Authors. Pediatric Transplantation published by John Wiley & Sons A/S. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
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Snippet | CMV infections are common after SOT. v‐GCV is increasingly used in children. The aim of this study was to evaluate presently used dosing algorithms. Data from... CMV infections are common after SOT. v-GCV is increasingly used in children. The aim of this study was to evaluate presently used dosing algorithms. Data from... Abstract CMV infections are common after SOT . v‐ GCV is increasingly used in children. The aim of this study was to evaluate presently used dosing algorithms.... |
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SubjectTerms | Adolescent Algorithms Antiviral Agents - administration & dosage Area Under Curve Child Child, Preschool Computer Simulation cytomegalovirus Cytomegalovirus Infections - drug therapy Drug Monitoring - methods Female Ganciclovir - administration & dosage Ganciclovir - analogs & derivatives Glomerular Filtration Rate Humans Infant Male Models, Theoretical Monte Carlo Method Organ Transplantation - methods Original pediatric transplantation population model Probability solid organ transplantation therapeutic drug monitoring valganciclovir |
Title | New algorithm for valganciclovir dosing in pediatric solid organ transplant recipients |
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