Successful Cost-Effective Prevention of Cytomegalovirus Disease in Kidney Transplant Recipients Using Low-Dose Valganciclovir.
Gheith O, Halim MA, et al.Experimental & Clinical Transplantation 2017; 15(Suppl 1): 156-163.
Aims
To assess the cost effectiveness of 450 mg versus 900 mg valganciclovir prophylaxis in kidney transplant recipients.
Interventions
Participants were randomized into two groups and received for 6 months post-transplant either low-dose valganciclovir (450 mg/d), or full-dose valganciclovir (900 mg/d).
Participants
201 kidney transplant recipients who could tolerate oral valganciclovir within 1 week post-transplant and were not allergic to valganciclovir.
Outcomes
Measured outcomes included the incidence of cytomegalovirus disease, leukopenia episodes, mycophenolate mofetil and valganciclovir dose reduction, requirement for granulocyte colony-stimulating factor treatment, patient survival, graft survival, rejection episodes, and associated costs.
Follow-up
12 months
CET Conclusions
This RCT compared standard (900 mg/d) to low (450 mg/d) dose valganciclovir for CMV prophylaxis in renal transplant recipients for 6 months. The study demonstrated less leucopenia, lower G-CSF use and less rejection in the low-dose group, with a non-significant trend toward less CMV infection. Cost of CMV treatment was lower in the low-dose group, although the overall cost was lower in the high-dose arm due to more frequent reductions in MMF dose (presumably secondary to leucopenia). There was no difference in graft function, graft or patient survival. These results appear to suggest that in an intermediate risk population (mainly CMV +/+ transplant) low dose valganciclovir for 6 months offers effective prophylaxis. Whether this holds true for higher risk seronegative recipients is unclear. There are also some methodological concerns – method of randomisation is not reported and the study is not blinded. There is a significant difference in baseline immunosuppression between the arms (higher tacrolimus use in the low-dose arm) which may be important as tacrolimus has previously been associated with lower rates of CMV infection in the literature.
Data analysis
Per protocol analysis
Trial registration
None