Public health need versus sales of antibacterial agents active against multidrug-resistant bacteria: a historical perspective

and the AUC0 – 12 was 24.5 mg.h/L. After 19 days of treatment, CMV PCR became negative. Oral valganciclovir was stopped after 4 weeks without adverse events. Along with the CMV PCR test becoming negative, proteinuria dramatically decreased, anaemia improved and digestive symptoms disappeared. At the 1 year follow-up, a CMV test was still negative and no relapse of nephrotic syndrome was noticed. This case report emphasizes the importance of dosage individualization of ganciclovir and valganciclovir, taking into account pharmacokinetic changes associated with renal disease. Ganciclovir is primarily excreted renally and, in the case reported here, the standard dose of 5 mg/kg resulted in a very low AUC, because nephrotic syndrome induced a high ganciclovir clearance. In order to achieve target AUC and optimize antiviral therapy, TDM-based dosage individualization of ganciclovir and valganciclovir is indispensable for children with renal disease.