Association between the Pharmacokinetic Parameters of Ganciclovir and Clinical Efficacy and Safety in the Treatment of Cytomegalovirus Infection

Cytomegalovirus (CMV) infection is a major cause of morbidity and mortality in immunocompromised patients. While ganciclovir (GCV) is commonly used for its management, pharmacokinetic (PK) targets for optimal efficacy and minimal toxicity remain controversial. This study aimed to explore the association of PK parameters with the efficacy and safety of GCV in the treatment of CMV infection. We conducted a prospective study of adult patients who received intravenous GCV for CMV infection. Treatment efficacy was defined as a ≥50% reduction in CMV antigen-positive cells using a pp65 antigenemia test. The highest or lowest hematological, hepatic, and renal laboratory values were used to assess safety. Individual PK parameters (area under the concentration–time curve [AUC]24h, trough [Cmin], and peak [Cmax]) plasma concentration were estimated using multiple GCV plasma concentrations from each patient. Associations between PK parameters and efficacy/safety were assessed. Of 23 patients, 20 (87.0%) exhibited an effective response. Median estimated AUC24h, Cmin, and Cmax values were 45.5 mg·h/L, 0.5 mg/L, and 6.8 mg/L, respectively. AUC24h and Cmin were not significantly associated with the efficacy of GCV (odds ratio [OR] 1.05, 95% confidence interval [CI] 0.96–1.16, p = 0.301; OR 0.92, 95% CI 0.11–7.86, p = 0.942). Cmax showed a relatively large but nonsignificant OR (OR 2.45, 95% CI 0.84–7.09, p = 0.099). No clinically relevant associations between PK parameters and safety were observed. Baseline laboratory values were associated with safety. In conclusion, no statistically significant associations were identified between GCV PK parameters and the treatment efficacy/safety of CMV infection in adult patients.