Critical analysis of valganciclovir dosing and renal function on the development of cytomegalovirus infection in kidney transplantation.
Posadas Salas MA, Taber DJ, et al.Transplant Infectious Disease 2013;15(6):551-8
Aims
To investigate the impact of valganciclovir dosing and renal function on the development of cytomegalovirus (CMV) in renal transplant recipients.
Interventions
This study was a post-hoc analysis of a randomized clinical trial in adult renal transplant recipients, comparing anti-thymocyte globulin and interleukin-2 inhibitors as induction immunosuppressive agents. This subanalysis grouped the patients based on those who developed CMV infection. Patients were either on valganciclovir therapy or they had completed therapy.
Participants
187 kidney transplant recipients.
Outcomes
The clinical outcomes included acute and borderline rejections, graft loss, patient death, infections and Leukopenia (white blood cell <3000/cc).
Follow-up
8 months - 1 year.
CET Conclusions
This report describes a retrospective analysis of data collected during a randomised controlled trial to establish risk factors for CMV infection (the previous trial compared ATG with IL-2 receptor antibodies for induction therapy in renal transplant patients). CMV infection was defined as significant CMV viremia (2x PCR >2000 copies/ml), CMV syndrome (clinical symptoms), or CMV disease (invasive or symptomatic disease with histological evidence of cytopathic effect). In multivariate analysis, the risk factors associated with CMV infection were: ATG induction, high-risk CMV serostatus, higher mean tacrolimus trough concentrations, body weight >80 kg and never achieving an estimated CrCl of at least 60 mL/min. Potentially the renal function of overweight patients is underestimated when calculating their CrCl using ideal body weight, and consequently they are underdosed with CMV prophylaxis.
Data analysis
Per protocol analysis
Quality notes
This study is a substudy, however the full paper has not yet been published – so the score is based on this paper by Posadas et al.
Trial registration
Not reported.