Introduction

Current guidelines on cytomegalovirus (CMV) prophylaxis following organ transplant recommend using valganciclovir (VGCV) 900 mg daily for high (CMV D+/R-) and intermediate (CMV R+) risk renal transplant (RT) patients with normal creatinine clearance. Potential benefits of low dose VGCV regimens include decreased drug-related side effects and cost. Breakthrough viremia and resistant CMV are intuitive concerns with reduced antiviral dosing. Here, we describe our center's experience using low dose VGCV among CMV R+ RT patients.

Methods

CMV R+ RT patients who received kidneys between 2/1/2013 and 3/31/2015 and had at least 6 months of follow-up after completion of CMV prophylaxis were included. Patients received VGCV 450 mg daily, and the dose was adjusted for renal function. CMV infection (CMVI) was defined as any detectable viremia. CMV disease (CMVD) was classified into CMV viral syndrome and tissue-invasive disease.

Results

Of 235 renal transplants, 101 met inclusion criteria. The incidence of CMVI and CMVD are reported in Table 1. There were no cases of CMV resistance. More CMV infected patients experienced acute cellular rejection (ACR) at 9/21 (42.86%) compared to 8/80 (10.0%) patients without CMVI (p=0.001). Only 1 patient experienced ACR prior to CMV diagnosis, all others occurred subsequently. Virus-associated malignancies occurred in 2/21 (4.76%) patients with CMVI compared to no patients without CMVI (p=0.042).

There was a trend towards increased mortality in patients with CMVI with 3/21 (14.29%) versus 3/80 (3.75%) deaths, however, this did not achieve significance (p=0.102). Baseline characteristics, graft loss, and opportunistic infections were similar between groups.

Conclusions

Reduced dose VGCV was associated with a high incidence of CMVI and CMVD in this study, but no cases of CMV resistance were identified. Further studies are necessary to determine whether low dose VGCV prophylaxis is non-inferior to guideline-recommended dosing in this patient population. Reductions in immunosuppression following diagnosis of CMVI may be associated with the observed increase in ACR.

CITATION INFORMATION: Baghban A, Belfield K, Azar M, Cohen E, Malinis M. Low-Dose Valganciclovir for Cytomegalovirus Prophylaxis in Intermediate Risk Renal Transplants: A Single Center Experience. Am J Transplant. 2017;17 (suppl 3).

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