A. Prophylaxis has mostly replaced preemptive therapy in CMV seronegative recipients of kidneys from seropositive donors (D+/R-). Primary infections occur commonly even after six months valganciclovir prophylaxis, and a hybrid approach has been suggested, with close monitoring after prophylaxis. We hypothesized that the burden of CMV infections remains high despite prolonged prophylaxis in this high-risk cohort.

B. Altogether 2448 kidney transplantations were performed in our country in 2004-2016, of which 449 adults had CMV D+/R- constellation, and received six months prophylaxis with valganciclovir 900 mg daily, adjusted for renal function (intention-to-treat). Incidence of primary CMV infections was analyzed from National Transplant Registry. In addition, detailed analysis was performed from 91 patients followed up at our institution, who were monitored for CMV DNAemia after the end of prophylaxis.

C. Late primary CMV infection occurred in 173/449 (39%) patients after prophylaxis. Of the patients monitored closely after prophylaxis and followed up at our institution, 46/91 (51%) developed CMV DNAemia, and 31/91 (34%) developed CMV disease. CMV infection occurred median 58 days (range 7-602) after the end of prophylaxis. In 17/46 (37%) patients primary infection occurred >3 months after the end of prophylaxis. CMV was treated with ganciclovir in 4 patients and 4 patients required no antiviral treatment; other 38 patients were successfully treated with valganciclovir. Hospitalization was required in 13 (28%) of patients. Median duration of viremia was 28 days, and median peak viral load was 6328 copies/ml plasma (range 205- 604233). Symptoms, most commonly fever and gastrointestinal symptoms, did not correlate with viral load and occurred even with viral loads <1000 copies/ml. Recurrent infection was detected in 46% of patients; in 9/27 (33% ) patients who received secondary prophylaxis and in 11/17 (65%) patients with no secondary prophylaxis (P=0.04).

D. The burden of primary CMV infections remains high after six months valganciclovir prophylaxis. Despite monitoring majority of infections were symptomatic. A significant proportion of primary infections occur >3 months after the end of prophylaxis, making close monitoring for infections challenging.

CITATION INFORMATION: Helanterä I., Ortiz F., Loginov R., Mannonen L., Lempinen M., Lautenschlager I. Burden of Primary CMV Infections Remains High Despite Six Months Valganciclovir Prophylaxis in High-Risk Kidney Transplant Recipients Am J Transplant. 2017;17 (suppl 3).

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