Extended Efficacy of Low-Dose Valganciclovir for Prevention of Cytomegalovirus Disease in Intermediate-Risk Kidney Transplant Recipients: Two-Year Follow-Up.

OBJECTIVES: In a previous study, we evaluated 1-year outcomes of using low-dose valganciclovir prophylaxis for cytomegalovirus infection in intermediate-risk kidney transplant recipients. Whether this effect persists in the long term is unknown. We aimed to evaluate the 2-year follow up of such adopted prophylaxis. MATERIALS AND METHODS: We randomized 2 matched groups of kidney transplant recipients (1:1) to receive valganciclovir as 450 mg daily (group 1) or 900 mg daily (group 2) for the first 6 months after kidney transplant. The final analysis included 196 patients as intermediate-risk patients (98 in each treatment group) after exclusion of 5 high-risk patients. Serologically, all patients were at moderate risk for cytomegalovirus infection. Long-term outcomes including cytomegalovirus disease, acute rejection, new-onset diabetes after transplant, graft loss, and patient survival were assessed. RESULTS: Through year 2 of follow-up, cytomegalovirus infection was reported in only 1 patient in group 1 (at month 13) and 1 patient in group 2 (at month 19) (not significant). Biopsy-proven acute rejection episodes were not statistically different between the groups (2 episodes in group 1 and 6 in group 2; P = .431). New-onset diabetes posttransplant was reported in 8.1% in group 1 and 13.2% in group 2 (P = .535). Graft failure was equal in both groups (1 in each group) at 2 years of follow up (not significant). Patient survival was comparable in both groups (100% in group 1 versus 97.9% in group 2; P = .661). The total number of cytomegalovirus infections at 2 years was numerically less in group 1 (P = .128). CONCLUSIONS: Low-dose valganciclovir prophylaxis for 6 months was associated with sustained reduction of cytomegalovirus infection up to 2 years after kidney transplant without significant impact on the acute rejection, new-onset diabetes posttransplant, or patient and graft outcomes.

Efficacy and Safety of Low-Dose Versus Standard-Dose Valganciclovir for Prevention of Cytomegalovirus Disease in Intermediate-Risk Kidney Transplant Recipients.

OBJECTIVES: Prophylaxis for cytomegalovirus infection is highly recommended for kidney transplant recipients. The use of daily 900 mg valganciclovir is the usual prophylactic dose, whereas 450 mg daily is under investigation. We evaluated the outcome of using 2 different doses of valganciclovir prophylaxis for cytomegalovirus infection after kidney transplant. MATERIALS AND METHODS: We randomized kidney transplant recipients (1:1) to receive 450 mg daily valganciclovir (group 1) or 900 mg daily valganciclovir (group 2) for the first 6 months after kidney transplant. Serologically, all patients were at moderate risk for cytomegalovirus infection. Patients were studied for incidence of cytomegalovirus disease, leukopenia attacks, rejection episodes, and graft outcomes for 1 year. RESULTS: Demographic features of group 1 (98 patients) and group 2 (98 patients) were comparable. More than 50% of patients received thymoglobulin induction therapy without difference between the groups. There were more leukopenia attacks in group 2 (P = .03) requiring higher doses of granulocyte colony-stimulating factor (P = .03). Group 2 patients received lower doses of mycophenolate mofetil (P= .04) and required reduced doses of valganciclovir (P = .045). Compared with group 1, the high-dose group developed numerically more rejection episodes (P = .057) and more cytomegalovirus infections requiring full treatment (P = .17). Graft and patient outcomes were satisfactory in both groups. CONCLUSION: Six months of low-dose valganciclovir prophylaxis for intermediate-risk kidney transplant recipients was as effective as high-dose valganciclovir with a better safety profile.