Evaluation of alternate-day valganciclovir prophylaxis for cytomegalovirus disease prevention in moderate risk renal transplant patients: A retrospective observational study

Background: Despite valganciclovir (VGCV) being the recommended agent for Cytomegalovirus (CMV) disease prevention, its optimal dose that maintains parity between the efficacies, toxicity profile, and most importantly, the cost has yet to be established. This study is the first to evaluate alternate day versus daily dose of VGCV prophylaxis in CMV prevention in moderate risk renal transplant patients (RTR). Materials and Methods: A single center, retrospective analysis of ninety-nine moderate risk RTR was done. The study participants received VGCV 450 mg/day (n = 49) versus VGCV 450 mg on alternative days (n = 50) for 90-100 days; as a prophylactic strategy against CMV disease. The primary endpoint was CMV disease incidence at 6 months. Graft survival, biopsy-proven rejection, hematological adverse events, opportunistic infections (OIs), and mortality have also been evaluated. Results: CMV disease occurrence at 6 months was zero in both the groups. Immunosuppression (induction and maintenance) were alike in both the groups except for higher tacrolimus trough levels in the 2nd month (P = 0.023) and lower mycophenolate acid area under curve levels in alternate-day group (P = 0.046). No difference was noted in biopsy-proven rejection, graft loss, mortality, and OIs, but leukopenia was more in patients receiving daily VGCV (P <= 0.001), a multivariate logistic regression revealed a higher incidence of leukopenia in the daily group (P = 0.02; odds ratio, 13.6, 95% confidence interval 1.51-122.37). Conclusions: Alternate-day VGCV dosing provides similar efficacy as daily dosing in CMV prevention in D+/R + RTR with reduced leukopenia incidence and significant cost-benefit.