Valganciclovir prophylaxis versus preemptive therapy in cytomegalovirus-positive renal allograft recipients: Long-term results after 7 years of a randomized clinical trial

Background The VIPP study compared valganciclovir prophylaxis with preemptive treatment regarding efficacy, safety and long-term graft outcome in CMV-positive (R+) renal transplant recipients. Methods Multicenter, open-label, randomized clinical study with a 12-month study phase and a follow-up of up to 84 months. Patients in the prophylaxis group received 2x450 mg/day oral valganciclovir for 100 days adjusted to renal function. Preemptive treatment with 2x900 mg/day valganciclovir was initiated at a viral load of ≥400 CMV copies/mL (PCR) and maintained over ≥14 days, followed by secondary prophylaxis. Patients were stratified by donor CMV IgG serostatus (D+/R+, D-/R+). Results The 12-month-results were reported previously (Witzke et al Transplantation 2012). The intent-to-treat/safety population comprised 148 patients in the prophylaxis (61.5% D+/R+) and 151 patients in the preemptive group (52.3% D+/R+). Overall, 47% patients completed the follow-up. Significantly fewer patients in the prophylaxis compared to preemptive group experienced a CMV infection or disease up to month 84 (11.5% [95% CI: 6.8%,17.8%] vs. 39.7% [31.9%,48.0%], p

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