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Pharmacology

Population Pharmacokinetics of Intravenous Ganciclovir and Oral Valganciclovir in a Pediatric Population To Optimize Dosing Regimens

T. Nguyen, M. Oualha, C. Briand, M. Bendavid, A. Béranger, S. Benaboud, J.-M. Tréluyer, Y. Zheng, F. Foissac, S. Winter, I. Gana, S. Boujaafar, V. Lopez, R. Berthaud, Z. Demir, N. Bouazza, D. Hirt
T. Nguyen
aEA7323, Evaluation des Thérapeutiques et Pharmacologie Périnatale et Pédiatrique, Université de Paris, Paris, France
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M. Oualha
aEA7323, Evaluation des Thérapeutiques et Pharmacologie Périnatale et Pédiatrique, Université de Paris, Paris, France
bService de Réanimation et Surveillance Continue Médico-Chirurgicales Pédiatriques, Hôpital Necker Enfants Malades, Paris, France
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C. Briand
cService d’Hématologie, Immunologie et Rhumatologie Pédiatrique, Hôpital Necker Enfants Malades, Paris, France
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M. Bendavid
bService de Réanimation et Surveillance Continue Médico-Chirurgicales Pédiatriques, Hôpital Necker Enfants Malades, Paris, France
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A. Béranger
aEA7323, Evaluation des Thérapeutiques et Pharmacologie Périnatale et Pédiatrique, Université de Paris, Paris, France
bService de Réanimation et Surveillance Continue Médico-Chirurgicales Pédiatriques, Hôpital Necker Enfants Malades, Paris, France
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S. Benaboud
aEA7323, Evaluation des Thérapeutiques et Pharmacologie Périnatale et Pédiatrique, Université de Paris, Paris, France
dService de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France
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J.-M. Tréluyer
aEA7323, Evaluation des Thérapeutiques et Pharmacologie Périnatale et Pédiatrique, Université de Paris, Paris, France
dService de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France
eUnité de Recherche Clinique Paris Descartes Necker Cochin, AP-HP, Paris, France
fCIC-1419 Inserm, Cochin-Necker, Paris, France
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Y. Zheng
aEA7323, Evaluation des Thérapeutiques et Pharmacologie Périnatale et Pédiatrique, Université de Paris, Paris, France
dService de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France
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F. Foissac
aEA7323, Evaluation des Thérapeutiques et Pharmacologie Périnatale et Pédiatrique, Université de Paris, Paris, France
eUnité de Recherche Clinique Paris Descartes Necker Cochin, AP-HP, Paris, France
fCIC-1419 Inserm, Cochin-Necker, Paris, France
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S. Winter
cService d’Hématologie, Immunologie et Rhumatologie Pédiatrique, Hôpital Necker Enfants Malades, Paris, France
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I. Gana
aEA7323, Evaluation des Thérapeutiques et Pharmacologie Périnatale et Pédiatrique, Université de Paris, Paris, France
dService de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France
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S. Boujaafar
aEA7323, Evaluation des Thérapeutiques et Pharmacologie Périnatale et Pédiatrique, Université de Paris, Paris, France
dService de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France
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V. Lopez
gService de Réanimation Cardiaque Pédiatrique, Hôpital Necker Enfants Malades, Paris, France
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R. Berthaud
aEA7323, Evaluation des Thérapeutiques et Pharmacologie Périnatale et Pédiatrique, Université de Paris, Paris, France
fCIC-1419 Inserm, Cochin-Necker, Paris, France
hService de Néphrologie Pédiatrique, Hôpital Necker Enfants Malades, Paris, France
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Z. Demir
iService de Gastro-Entérologie, Hépatologie et Nutrition Pédiatriques, Hôpital Necker Enfants Malades, Paris, France
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N. Bouazza
aEA7323, Evaluation des Thérapeutiques et Pharmacologie Périnatale et Pédiatrique, Université de Paris, Paris, France
eUnité de Recherche Clinique Paris Descartes Necker Cochin, AP-HP, Paris, France
fCIC-1419 Inserm, Cochin-Necker, Paris, France
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D. Hirt
aEA7323, Evaluation des Thérapeutiques et Pharmacologie Périnatale et Pédiatrique, Université de Paris, Paris, France
dService de Pharmacologie Clinique, AP-HP, Hôpital Cochin, Paris, France
jINSERM, U1018, Hôpital de Bicêtre, Le Kremlin-Bicêtre, France
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  • ORCID record for D. Hirt
DOI: 10.1128/AAC.02254-20
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ABSTRACT

Ganciclovir is indicated for curative or preventive treatment of cytomegalovirus (CMV) infections. This study aimed to characterize ganciclovir pharmacokinetics, following intravenous ganciclovir and oral valganciclovir administration, to optimize dosing schemes. All children aged <18 years receiving ganciclovir or valganciclovir were included in this study. Pharmacokinetics were described using nonlinear mixed-effect modeling. Monte Carlo simulations were used to optimize the dosing regimen to maintain the area under the concentration-time curve (AUC) in the preventive or therapeutic target. Among the 105 children (374 concentration-time observations) included, 78 received intravenous (i.v.) ganciclovir, 19 received oral valganciclovir, and 6 received both drugs. A two-compartment model with first-order absorption for valganciclovir and first-order elimination best described the data. An allometric model was used to describe the bodyweight (BW) effect. Estimated glomerular filtration rate (eGFR) and medical status of critically ill children were significantly associated with ganciclovir elimination. Recommended doses were adapted for prophylactic treatment. To obtain a therapeutic exposure, doses should be increased to 40 mg/kg of body weight/day oral or 15 to 20 mg/kg/day i.v. in children with normal eGFR and to 56 mg/kg/day oral or 20 to 25 mg/kg/day i.v. in children with augmented eGFR. These doses should be prospectively confirmed, and therapeutic drug monitoring could be used to refine them individually. (This study has been registered at ClinicalTrials.gov under identifier NCT02539407.)

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Population Pharmacokinetics of Intravenous Ganciclovir and Oral Valganciclovir in a Pediatric Population To Optimize Dosing Regimens
T. Nguyen, M. Oualha, C. Briand, M. Bendavid, A. Béranger, S. Benaboud, J.-M. Tréluyer, Y. Zheng, F. Foissac, S. Winter, I. Gana, S. Boujaafar, V. Lopez, R. Berthaud, Z. Demir, N. Bouazza, D. Hirt
Antimicrobial Agents and Chemotherapy Feb 2021, 65 (3) e02254-20; DOI: 10.1128/AAC.02254-20

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Population Pharmacokinetics of Intravenous Ganciclovir and Oral Valganciclovir in a Pediatric Population To Optimize Dosing Regimens
T. Nguyen, M. Oualha, C. Briand, M. Bendavid, A. Béranger, S. Benaboud, J.-M. Tréluyer, Y. Zheng, F. Foissac, S. Winter, I. Gana, S. Boujaafar, V. Lopez, R. Berthaud, Z. Demir, N. Bouazza, D. Hirt
Antimicrobial Agents and Chemotherapy Feb 2021, 65 (3) e02254-20; DOI: 10.1128/AAC.02254-20
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KEYWORDS

antiviral drug
children
population pharmacokinetics

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