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Peer-reviewedCC BY 4.0Basic & Clinical Pharmacology & Toxicology

Renal Function–Guided Valganciclovir Dosing and Ganciclovir Exposure Variability: A Population Pharmacokinetic Simulation Study

  • Franck Maizaud1,2
  • Marc Labriffe1,2,3
  • Hamza Sayadi1,2
  • Stéphanie Belaiche4,5,6
  • Pierre Marquet1,2,3
  • Jean‐Baptiste Woillard1,2,3
  • Caroline Monchaud1,2,3
6 affiliations
  1. 1Department of Pharmacology, Toxicology and Pharmacovigilance CHU Limoges Limoges France
  2. 2INSERM UMR‐1248 “Pharmacology & Transplantation” Limoges France
  3. 3University Hospital Federation “Survival Optimization in Organ Transplantation” (FHU SUPORT) Limoges France
  4. 4Institute of Pharmacy CHU Lille Lille France
  5. 5Department of Gastroenterology CHU Lille Lille France
  6. 6METRICS Research Laboratory (ULR 2694) Lille University Lille France
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Abstract

Background: Ganciclovir (GCV) exposure after standard valganciclovir (VGCV) prophylaxis is highly variable. Guidelines recommend Cockcroft–Gault for renal dose adjustment. We evaluated whether Cockcroft–Gault‐based dosing achieves the target prophylactic exposure (AUC0‐24h: 40–60 mg.h/L) and whether MDRD or CKD‐EPI alters exposure.

Methods: Using a validated population pharmacokinetic model, we simulated 10 000 adult solid organ transplant recipients. VGCV doses were assigned according to SmPC renal function categories based on Cockcroft–Gault, MDRD or CKD‐EPI. Patient reclassification, target attainment and exposure around dosing thresholds (25, 40 and 60 mL/min) were assessed.

Results: MDRD and CKD‐EPI reclassified 45.1% and 39.9% of patients, mostly downward, lowering target attainment (20.1% and 22.7% vs. 30.8% with Cockcroft–Gault). Target attainment never exceeded 40% in any category, and underexposure predominated, reaching up to 94.1% in the most impaired renal function categories. Target attainment was consistently lower just below each threshold, and the 25 and 40 mL/min thresholds were set above the renal function ranges where the corresponding regimens achieved target exposure.

Conclusions: Renal function category‐based VGCV dosing does not reliably achieve target GCV exposure. Current thresholds are poorly aligned with the exposure‐response relationship and warrant re‐examination. Alternative equations do not reduce the variability, supporting exposure‐guided approaches such as therapeutic drug monitoring and model‐informed precision dosing.

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Cite

BibTeXRIS
BibTeX
@article{maizaud2026renal,
  title = {{Renal Function–Guided Valganciclovir Dosing and Ganciclovir Exposure Variability: A Population Pharmacokinetic Simulation Study}},
  author = {Franck Maizaud and Marc Labriffe and Hamza Sayadi and Stéphanie Belaiche and Pierre Marquet and Jean‐Baptiste Woillard and Caroline Monchaud},
  journal = {Basic \& Clinical Pharmacology \& Toxicology},
  year = {2026},
  month = nov,
  doi = {10.1111/bcpt.70329},
  url = {https://doi.org/10.1111/bcpt.70329},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Renal Function–Guided Valganciclovir Dosing and Ganciclovir Exposure Variability: A Population Pharmacokinetic Simulation Study
AU  - Franck Maizaud
AU  - Marc Labriffe
AU  - Hamza Sayadi
AU  - Stéphanie Belaiche
AU  - Pierre Marquet
AU  - Jean‐Baptiste Woillard
AU  - Caroline Monchaud
PY  - 2026
DA  - 2026/11/05
JO  - Basic & Clinical Pharmacology & Toxicology
DO  - 10.1111/bcpt.70329
UR  - https://doi.org/10.1111/bcpt.70329
AB  - Background: Ganciclovir (GCV) exposure after standard valganciclovir (VGCV) prophylaxis is highly variable. Guidelines recommend Cockcroft–Gault for renal dose adjustment. We evaluated whether Cockcroft–Gault‐based dosing achieves the target prophylactic exposure (AUC0‐24h: 40–60 mg.h/L) and whether MDRD or CKD‐EPI alters exposure.  Methods: Using a validated population pharmacokinetic model, we simulated 10 000 adult solid organ transplant recipients. VGCV doses were assigned according to SmPC renal function categories based on Cockcroft–Gault, MDRD or CKD‐EPI. Patient reclassification, target attainment and exposure around dosing thresholds (25, 40 and 60 mL/min) were assessed.  Results: MDRD and CKD‐EPI reclassified 45.1% and 39.9% of patients, mostly downward, lowering target attainment (20.1% and 22.7% vs. 30.8% with Cockcroft–Gault). Target attainment never exceeded 40% in any category, and underexposure predominated, reaching up to 94.1% in the most impaired renal function categories. Target attainment was consistently lower just below each threshold, and the 25 and 40 mL/min thresholds were set above the renal function ranges where the corresponding regimens achieved target exposure.  Conclusions: Renal function category‐based VGCV dosing does not reliably achieve target GCV exposure. Current thresholds are poorly aligned with the exposure‐response relationship and warrant re‐examination. Alternative equations do not reduce the variability, supporting exposure‐guided approaches such as therapeutic drug monitoring and model‐informed precision dosing.
SN  - 1742-7835
SN  - 1742-7843
ER  -