Evidence map›Paper›PMID 40411698›Full record

ArticleClinical pharmacokinetics2025

Pharmacokinetic/Pharmacodynamic Modelling and Monte Carlo Simulations to Predict Cytomegalovirus Viral Load in Pediatric Transplant Recipients Treated with (val)Ganciclovir.

Kévin Koloskoff, Bénédicte Franck, Sylvain Benito, Julien Welzel, Julie Autmizguine, Yves Theoret, Annabelle Briand, Philippe Ovetchkine, Jean-Baptiste Woillard

Abstract read
In one paragraph

Article in Clinical pharmacokinetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Kévin KoloskoffINSERM, University of Limoges, CHU Limoges, P&T, U1248, 2 Rue du Pr Descottes, 87000, Limoges, France.
Bénédicte FranckDepartment of Clinical and Biological Pharmacology and Pharmacovigilance, Clinical Investigation Center, CIC-P 1414, Rennes, France.
Sylvain BenitoExactCure, Nice, France.
Julien WelzelExactCure, Nice, France.
Julie AutmizguineResearch Center, Centre Hospitalier Universitaire, Sainte-Justine, Montreal, QC, Canada.
Yves TheoretDepartment of Pharmacology and Physiology, Université de Montréal, Montreal, QC, Canada.
Annabelle BriandDepartment of Pediatrics, Centre Hospitalier Universitaire, Sainte-Justine, Montreal, QC, Canada.
Philippe OvetchkineDepartment of Pediatrics, Centre Hospitalier Universitaire, Sainte-Justine, Montreal, QC, Canada.
Jean-Baptiste WoillardINSERM, University of Limoges, CHU Limoges, P&T, U1248, 2 Rue du Pr Descottes, 87000, Limoges, France. jean-baptiste.woillard@unilim.fr.ORCID 0000-0003-1695-0695

Funding

Agence Nationale de la Recherche ANR-22-PESN-0017Association Nationale de la Recherche et de la Technologie 2021/1440
6 · The paper itself

Abstract

BACKGROUND AND

objectivesCytomegalovirus (CMV) infection poses significant challenges in pediatric transplant recipients. Ganciclovir and its prodrug valganciclovir are primary treatments because of their potent antiviral effects. Balancing efficacy and toxicity is particularly critical in children. This study aimed to develop a pharmacokinetic/pharmacodynamic (PK/PD) model for (val)ganciclovir and assess the relationship between area under the concentration-time curve (AUC) and CMV viral loads via Monte Carlo simulations.

methodsWe conducted a retrospective analysis including 184 viral load samples from 36 transplanted children treated with ganciclovir/valganciclovir. We developed a population pharmacodynamic model using Monolix and performed Monte Carlo simulations to assess viral load decline with varying AUCs. Internal validation was performed using goodness-of-fit plots and bootstraps.

resultsWe used a viral turnover model with stimulated degradation to model the pharmacodynamic data. Model validation showed no bias or misspecification. Simulations indicated that maintaining an AUC

conclusionThe pharmacodynamic model accurately predicted observed data. Simulations indicated that maintaining a ganciclovir plasma AUC

Indexed as

Antiviral AgentsCytomegalovirusCytomegalovirus InfectionsGanciclovirModels, BiologicalValganciclovirViral LoadAdolescentArea Under CurveChildChild, PreschoolFemaleHumansInfantMaleMonte Carlo MethodAntiviral AgentsGanciclovirValganciclovir

Identifiers

PMID40411698
PMCPMC12185614

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.