Trial reportAntimicrobial agents and chemotherapy2016
Contribution of Population Pharmacokinetics to Dose Optimization of Ganciclovir-Valganciclovir in Solid-Organ Transplant Patients.
Trial report in Antimicrobial agents and chemotherapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01446445 (Individualization of Ganciclovir and Valganciclovir Doses in Renal Transplant Patients for Prophylaxis or Treatment of Cytomegalovirus), which is not on this map. Cited by 18 papers, 4 of them syntheses that pooled it.
What it found
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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.
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.
Individualization of Ganciclovir and Valganciclovir Doses in Renal Transplant Patients for Prophylaxis or Treatment of Cytomegalovirus(CMV)Infection Using Bayesian Prediction.
Who cites it
18 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients.The Cochrane database of systematic reviews · 2025Pooled it
- Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients.The Cochrane database of systematic reviews · 2024Pooled it
- Too Much of a Good Thing: Defining Antimicrobial Therapeutic Targets to Minimize Toxicity.Clinical pharmacology and therapeutics · 2021Pooled it
- Exploring failure of antimicrobial prophylaxis and pre-emptive therapy for transplant recipients: a systematic review.BMJ open · 2020Pooled it
- Optimization of Valganciclovir for Treatment of Cytomegalovirus Infection in Pediatric Liver Transplant Recipients: A Prospective Pharmacokinetic Study.Transplantation direct · 2026Article
- Optimization of Preemptive Therapy for Cytomegalovirus Infections With Valganciclovir Based on Therapeutic Drug Monitoring: Protocol for a Phase II, Single-Center, Single-Arm Trial.JMIR research protocols · 2025Article
- Estimation of Ganciclovir Exposure in Adults Transplant Patients by Machine Learning.The AAPS journal · 2025Article
- Optimization of Ganciclovir and Valganciclovir Starting Dose in Children by Machine Learning.Clinical pharmacokinetics · 2024Article
- Comparison of Three Renal Function Formulas for Ganciclovir/Valganciclovir Dose Individualization in CMV-Infected Solid Organ Transplantation Patients Using a Population Approach.Clinical pharmacokinetics · 2023Article
- Population Pharmacokinetics of Ganciclovir in Allogeneic Hematopoietic Stem Cell Transplant Patients.Antimicrobial agents and chemotherapy · 2023Observational
- Population Pharmacokinetic and Pharmacodynamic Analysis of Valganciclovir for Optimizing Preemptive Therapy of Cytomegalovirus Infections in Kidney Transplant Recipients.Antimicrobial agents and chemotherapy · 2023Article
- Detection of Ganciclovir-Resistant Cytomegalovirus in a Prospective Cohort of Kidney Transplant Recipients Receiving Subtherapeutic Valganciclovir Prophylaxis.Microbiology spectrum · 2022Article
- Valganciclovir is not associated with decreased EBV infection rate in pediatric kidney transplantation.Frontiers in pediatrics · 2022Article
- White paper on antimicrobial stewardship in solid organ transplant recipients.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2022Article
- Thoroughly Validated Bayesian Estimator and Limited Sampling Strategy for Dose Individualization of Ganciclovir and Valganciclovir in Pediatric Transplant Recipients.Clinical pharmacokinetics · 2021Article
- Variants in mycophenolate and CMV antiviral drug pharmacokinetic and pharmacodynamic genes and leukopenia in heart transplant recipients.The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2021Article
- Antimicrobial therapeutic drug monitoring in critically ill adult patients: a Position PaperIntensive care medicine · 2020Review
- Valganciclovir Pharmacokinetics in Patients Receiving Oral Prophylaxis Following Kidney Transplantation and Model-Based Predictions of Optimal Dosing Regimens.Clinical pharmacokinetics · 2018Article
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Treatment of solid-organ transplant (SOT) patients with ganciclovir (GCV)-valganciclovir (VGCV) according to the manufacturer's recommendations may result in over- or underexposure. Bayesian prediction based on a population pharmacokinetics model may optimize GCV-VGCV dosing, achieving the area under the curve (AUC) therapeutic target. We conducted a two-arm, randomized, open-label, 40% superiority trial in adult SOT patients receiving GCV-VGCV as prophylaxis or treatment of cytomegalovirus infection. Group A was treated according to the manufacturer's recommendations. For group B, the dosing was adjusted based on target exposures using a Bayesian prediction model (NONMEM). Fifty-three patients were recruited (27 in group A and 26 in group B). About 88.6% of patients in group B and 22.2% in group A reached target AUC, achieving the 40% superiority margin (P< 0.001; 95% confidence interval [CI] difference, 47 to 86%). The time to reach target AUC was significantly longer in group A than in group B (55.9 ± 8.2 versus 15.8 ± 2.3 days,P< 0.001). A shorter time to viral clearance was observed in group B than in group A (12.5 versus 17.6 days;P= 0.125). The incidences of relapse (group A, 66.67%, and group B, 9.01%) and late-onset infection (group A, 36.7%, and group B, 7.7%) were higher in group A. Neutropenia and anemia were related to GCV overexposure. GCV-VCGV dose adjustment based on a population pharmacokinetics Bayesian prediction model optimizes GCV-VGCV exposure. (This study has been registered at ClinicalTrials.gov under registration no. NCT01446445.).
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