Introduction: Cytomegalovirus (CMV) remains one the most clinically relevant and frequent post-transplant infections. Despite the availability of effective antiviral drugs, CMV continues to be of major clinical concern in transplant populations. Valganciclovir (VGCV) dose and duration for prophylaxis differs among institutions, and may be based on experience and consensus rather than clinical trials. The purpose of this analysis is to assess the prevalence and determine the risk factors of CMV viremia and disease in renal transplant recipients (RTR) at risk of CMV, using low-dose VGCV for 6 months.

Methods: A retrospective cohort study was conducted on adult RTR between January 1, 2008, and December 31, 2015 using electronic medical records. Patients were included if they were aged 18 years or older, were followed at our institution for at least one year after transplant, and were at risk for CMV (D+/R+, D+/R-, D-/R+). CMV D-/R- patients were excluded. The primary objective was to evaluate the incidence of CMV viremia, CMV disease, breakthrough, and resistance at one year post-transplant.

Results: A total of 461 RTR charts were reviewed. Of those, 291 patients were included in the study (46.4% D+/R+, 26.8%, D-/R+ and 26.8% D+/R-). Within the first year of transplant, 40 patients (13.7%) developed CMV viremia within 12 months post-transplant. Of those, 23 patients (57.5%) experienced asymptomatic viremia, and 17 (42.5%) had CMV disease, viral syndrome or tissue-invasive. The incidence of breakthrough was 2.75% and ganciclovir-resistance 2.4%. Early discontinuation of VGCV occurred in 59 patients (20.3%), mainly due to leukopenia (93.2%). A multiregression analysis revealed that D+/R- population had a 3.8 times higher risk of developing positive viral load (p=0.004), patients who experienced AMR had 6 times higher risk of developing CMV disease (p=0.002), and presence of concomitant opportunistic infections (OI) increased the risk by 4 times (p=0.0001). In addition, D+/R- group and presence of AMR increased the risk of CMV disease by 12 times (p=0.005, and p=0.001, respectively). Ganciclovir-resistance was associated with AMR and concomitant OI (p=0.01, and p=0.035, respectively).

Conclusion: A low-dose VGCV regimen provides low rate of viremia, and viral disease in RTR. High risk population (D+/R-), and presence of AMR were highly associated with CMV incidence.

CITATION INFORMATION: El Hajj S, Kim M, Azzi J, Gabardi S. Eight Years of Low-Dose Valganciclovir; Evaluating the Incidence and Risk Factors of CMV in Kidney Transplant Recipients. Am J Transplant. 2017;17 (suppl 3).

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