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ABSTRACT: Background
The use of (val)ganciclovir is complicated by toxicity, slow response to treatment and acquired resistance.Objectives
To evaluate a routine therapeutic drug monitoring (TDM) programme for ganciclovir in a transplant patient population.Methods
An observational study was performed in transplant recipients from June 2018 to February 2020. Dose adjustments were advised by the TDM pharmacist as part of clinical care. For prophylaxis, a trough concentration (Cmin) of 1-2 mg/L and an AUC24h of >50 mg·h/L were aimed for. For treatment, a Cmin of 2-4 mg/L and an AUC24h of 80-120 mg·h/L were aimed for.Results
Ninety-five solid organ and stem cell transplant patients were enrolled. Overall, 450 serum concentrations were measured; with a median of 3 (IQR = 2-6) per patient. The median Cmin and AUC24h in the treatment and prophylaxis groups were 2.0 mg/L and 90 mg·h/L and 0.9 mg/L and 67 mg·h/L, respectively. Significant intra- and inter-patient patient variability was observed. The majority of patients with an estimated glomerular filtration rate of more than 120 mL/min/1.73 m2 and patients on continuous veno-venous haemofiltration showed underexposure. The highest Cmin and AUC24h values were associated with the increase in liver function markers and decline in WBC count as compared with baseline.Conclusions
This study revealed that a standard weight and kidney function-based dosing regimen resulted in highly variable ganciclovir Cmin and under- and over-exposure were observed in patients on dialysis and in patients with increased renal function. Clearly there is a need to explore the impact of concentration-guided dose adjustments in a prospective study.
SUBMITTER: Martson AG
PROVIDER: S-EPMC8361328 | biostudies-literature | 2021 Aug
REPOSITORIES: biostudies-literature
Märtson Anne-Grete AG Edwina Angela E AE Burgerhof Johannes G M JGM Berger Stefan P SP de Joode Anoek A Damman Kevin K Verschuuren Erik A M EAM Blokzijl Hans H Bakker Martijn M Span Lambert F LF van der Werf Tjip S TS Touw Daan J DJ Sturkenboom Marieke G G MGG Knoester Marjolein M Alffenaar Jan W C JWC
The Journal of antimicrobial chemotherapy 20210801 9
<h4>Background</h4>The use of (val)ganciclovir is complicated by toxicity, slow response to treatment and acquired resistance.<h4>Objectives</h4>To evaluate a routine therapeutic drug monitoring (TDM) programme for ganciclovir in a transplant patient population.<h4>Methods</h4>An observational study was performed in transplant recipients from June 2018 to February 2020. Dose adjustments were advised by the TDM pharmacist as part of clinical care. For prophylaxis, a trough concentration (Cmin) of ...[more]