Efficacy and toxicity analysis of ganciclovir in patients with cytomegalovirus lung infection: what is new for target range of therapeutic drug monitoring

Objectives To investigate the relationship between ganciclovir trough concentration and its clinical efficacy and safety in patients with pulmonary cytomegalovirus (CMV) infection. To evaluate the target value of therapeutic drug monitoring (TDM) for predicting clinical efficacy or toxicity. Methods An observational study was conducted on patients with CMV lung infection between Jan 2021 and Dec 2023. Target trough ganciclovir concentrations were collected during TDM and clinical outcomes and adverse events (AEs) were assessed. Multiple regression analyses or binary logistic regression were used to analyze the factors affecting ganciclovir trough concentrations and clinical efficacy. Receiver operating characteristic (ROC) curve analysis identified ganciclovir trough concentration cutoffs as predictors of toxicity. Results Of 149 included patients, only 19.22% of trough concentrations reached the target range of 2–4µg/ml. Diabetes, organ transplantation, and elevated hemoglobin levels decrease trough concentrations, whereas elevated blood creatinine and continuous renal replacement therapy (CRRT) increase trough concentrations. No relationship was found between the trough concentrations and clinical outcomes. Organ transplantation, duration of ganciclovir administration, and albumin levels affect the clinical efficacy. ROC analysis identified ganciclovir trough concentrations of 0.985 µg/ml (AUC = 0.600) and 0.995 µg/ml (AUC = 0.701), associated with decreased hemoglobin and elevated blood creatinine levels, respectively. Conclusions No association was observed between ganciclovir trough concentration and clinical efficacy. However, thresholds for ganciclovir trough concentrations causing decreased hemoglobin and increased blood creatinine levels were identified. Renal replacement therapy is more likely to lead to elevated trough concentrations of ganciclovir. These findings suggest the importance of TDM for ganciclovir, and new target range should be considered.