Increased Risk of Breakthrough Infection among Cytomegalovirus Donor Positive/Recipient Negative Kidney Transplant Recipients Receiving Lower Dose Valganciclovir Prophylaxis
Pharmacy, Hospital of Univ of Pennsylvania, Philadelphia
Medicine, Perelman School of Medicine, Univ of Pennsylvania, Philadelphia
Transplant Surgery, Perelman School of Medicine, Univ of Pennsylvania, Philadelphia
Meeting: 2013 American Transplant Congress
Abstract number: B970
Data suggests that lower dose (LD, 450mg/day for 6 months) valganciclovir prophylaxis (VGV PPX) is non-inferior to standard dose (SD, 900mg/day for 6 months) VGV PPX in cytomegalovirus (CMV) donor positive/recipient negative (high-risk) kidney recipients with potential benefits of reduced cost and side effects. Based on this data, our center changed VGV PPX from SD to LD in May 2011 for all high-risk kidney recipients. Purpose: To compare the effectiveness of LD to SD VGV PPX for CMV prevention in high-risk kidney recipients. Methods: We performed a retrospective cohort study to compare CMV rates in high-risk kidney recipients receiving either LD or SD VGV PPX. All patients were followed from transplant to 11/1/12 or until development of CMV, death, or loss to follow-up; CMV screening on PPX was only done if suggestive symptoms or abnormal labs present. Our immunosuppressive protocol (rabbit antithymocyte globulin, tacrolimus, mycophenolic acid, steroids) was the same during both periods. Results: 48 patients initiated SD VGV PPX in the 18 months pre-PPX update. There were no cases of breakthrough CMV while on PPX. In the 16 months post-PPX update, 51 patients initiated LD VGV PPX, and 6 developed CMV while receiving LD PPX (p=0.03). Median time to CMV breakthrough infection was 3.4 months (range 1.9-5.6). One patient with CMV had suspected noncompliance. Ganciclovir resistance was suspected in 1 patient with persistent viremia. Late onset CMV infection occurred in 11 (23%) SD VGV patients and 7 (14%) LD VGV respectively (p = 0.24). Median time to any CMV infection in the SD and LD groups was 8.1 months (range 6.8-14.8) and 5.6 months (range 1.9-13.2), respectively (p = 0.02). Overall median follow up was 22.5 months (range 0.5-30) in SD group and 7.9 months (range 1.3-17.5) in LD group. Conclusion: While overall rates of CMV did not differ, breakthrough infection while receiving VGV PPX only occurred in LD VGV-treated patients. Given the increased risk of ganciclovir resistance when PPX is under-dosed, SD VGV should be used in all CMV high-risk kidney recipients.
To cite this abstract in AMA style:
Stevens D, Trofe-Clark J, Blumberg E, Wilck M, Weikert B, Goral S, Bleicher M, Sawinski D, Abt P, Levine M, Porrett P, Bloom R. Increased Risk of Breakthrough Infection among Cytomegalovirus Donor Positive/Recipient Negative Kidney Transplant Recipients Receiving Lower Dose Valganciclovir Prophylaxis [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/increased-risk-of-breakthrough-infection-among-cytomegalovirus-donor-positiverecipient-negative-kidney-transplant-recipients-receiving-lower-dose-valganciclovir-prophylaxis/. Accessed May 11, 2025.« Back to 2013 American Transplant Congress