Incidence of Cytomegalovirus UL97 and UL54 Amino Acid Substitutions Detected After 100 or 200 Days of Valganciclovir Prophylaxis.
Boivin G, Goyette N, et al.Journal of Clinical Virology 53(3):208-13, 2012.
Aims
To determine whether or not extending valganciclovir prophylaxis from 100 days to 200 days would increase the incidence of ganciclovir resistance in renal transplant patients.
Interventions
100 days of valganciclovir prophylaxis (900 mg once daily) versus 200 days of valganciclovir prophylaxis.
Participants
318 cytomegalovirus (CMV) sero-negative renal transplant patients who received an organ from a sero-positive donor.
Outcomes
Ganciclovir resistance criteria defined by positive viral load, CMV disease/infection, CMV syndrome or tissue invasive CMV. Genotypic analysis was conducted to detect ganciclovir resistance mutation.
Follow-up
12 months
CET Conclusions
This interesting randomised, double blind study (IMPACT study) showed that there was a significant reduction in CMV disease in patients receiving 200 days prophylaxis with valganciclovir prophylaxis compared to 100 days. Paying particular attention to mutations associated with valganciclovir resistance did not reveal any major difference. Thus extending valganciclovir prophylaxis from 100 days to 200 days did not significantly affect the incidence of valganciclovir resistance.
Data analysis
Modified intention-to-treat analysis
Quality notes
This is a subgroup analysis of a previous publication of the same RCT: Humar A, Lebranchu Y, et al. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high risk kidney transplant recipients. Am J Transplant 2010;10:1228–37. The methodological quality assessment was based on the previous publication.
Trial registration
NCT00294515 (ClinicalTrials.gov)