renal transplantation. clinical - 1

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GUIDE GANCICLOVIR/VALGANCICLOVIR DOSAGE IN KIDNEY. TRANSPLANT PATIENTS. Ariadna Padullés1, Helena Colom2, Oriol Bestard3, Joan Torras3, ...
Nephrology Dialysis Transplantation 30 (Supplement 3): iii348–iii376, 2015 doi:10.1093/ndt/gfv185.1

RENAL TRANSPLANTATION. CLINICAL - 1 FP812

CONTRIBUTION OF POPULATION PHARMACOKINETICS TO GUIDE GANCICLOVIR/VALGANCICLOVIR DOSAGE IN KIDNEY TRANSPLANT PATIENTS

Ariadna Padullés1, Helena Colom2, Oriol Bestard3, Joan Torras3, Gema Cerezo3, Raul Rigo4, Eduardo Melilli3, Anna Caldés3, Nuria Sabé5, Jordi Niubó6, Nicolás Manito7, Laura Lladó8, Josep M Cruzado3, Josep M Grinyó3 and Nuria LLoberas9 1 Hospital Bellvitge, Pharmacy, Barcelona, Spain, 2School of Pharmacy, Barcelona University, Pharmacy and Pharmaceutical Technology Department. Biopharmaceutics and Pharmacokinetics Unit, Barcelona, Spain, 3Hospital Bellvitge, Nephrology, Barcelona, Spain, 4Hospital Bellvitge, Clinical Biochemistry, Barcelona, Spain, 5Hospital Bellvitge, Infectious Diseases, Barcelona, Spain, 6 Hospital Bellvitge, Microbiology Department, Barcelona, Spain, 7Hospital Bellvitge, Cardiology, Barcelona, Spain, 8Hospital Bellvitge, Digestive Surgery, Barcelona, Spain, 9Hospital Bellvitge, Neprology, Barcelona, Spain Introduction and Aims: Our group has previously shown that treatment of solid organ transplant (SOT) patients with ganciclovir (GCV) or valganciclovir (VGCV) following the manufacturer’s dosing recommendations may result in either over or underexposure to the drug. The current study was designed to test whether a previously

developed population pharmacokinetics (PPK) based Bayesian prediction model could be used to optimize GCV dosing to achieve desirable area under the curve (AUC) therapeutic target values of 40-50 μgh/mL. Methods: A two arm, randomized, open-label, clinical superiority trial (superiority margin = 40%) was carried out in adult SOT patients receiving GCV/VGCV either as prophylaxis or treatment of CMV infection. Group A received GCV/VGCV according to the manufacturer’s dosing recommendations. Group B received adjusted doses of GCV/VGC based on desirable exposure targets using a Bayesian prediction model (NONMEM). Exclusion criteria was a creatinine clearance (CLCR)