Cytomegalovirus Pp65 Antigen-Guided Preemptive Therapy With Ganciclovir in Solid Organ Transplant Recipients: A Prospective, Double-Blind, Placebo-Controlled Study

Abstract

Preemptive antiviral therapy guided by the pp65 antigen test seems to have a beneficial effect on preventing HCMV-associated symptoms in kidney and liver transplant recipients.

Monitoring for human cytomegalovirus infection in solid organ transplant recipients through antigenemia and glycoprotein N (gN) variants: evidence of correlation and potential prognostic value of gN genotypes

“…To decrease the incidence of HCMV disease after transplantation, two main strategies have been developed: 1) universal prophylaxis, which consists in prophylactic antiviral therapy to all patients, resulting in a costly and indiscriminate administration of antivirals, with their side-effects and the possible emergence of resistant strains; 2) pre-emptive therapy, which is based on the routine screening of patients and administration of antiviral drugs to those evidencing HCMV infection before the development of any symptom. The latter strategy has led to an improvement in laboratory assays for the early detection of HCMV infection and the identification of patients at high risk of developing HCMV disease [5,6,26,34].…”

“…The number of positive cells correlates well with active infection [22,[35][36][37]. Furthermore, high antigenemia values have been associated with clinical signs of illness [23,24,34] and constitute a guide for pre-emptive therapy [25,26,34].…”

“…This study also reports on the potential predictive value of gN genotypes for the number of pp65-positive cells detected by antigenemia assay. The antigenemia cut-off was set at 50 cells/2 × 10 5 PBLs, as previous reports [25,27,29,34] showed that this value was an index of massive HCMV infection in transplant patients and often predictive of symptomatic infection. Our data showed that the gN-1 and gN-4b variants are good predictors of low (< 50 pp65-positive cells) and high values (> 50 pp65-positive cells) of antigenemia, respectively.…”

Gastrointestinal infections caused by cytomegalovirus

“…The ability to use a sensitive method to estimate CMV viral load has proved particularly helpful in the management of CMV disease in hematologic and solid organ transplant recipients [10,11•,12]. In many transplant centers, for example, prospective evaluation of CMV viral load is used to screen for the emergence of reactivation disease following periods of CMV prophylaxis, and also underlies the emerging practice of using targeted or socalled "pre-emptive" antiviral strategies in high-risk patient populations [13][14][15][16].…”

The case for cytomegalovirus prophylaxis in solid organ transplantation

“…Prophylaxis refers to the treatment of all patients prior to the detection of active CMV replication from time of transplantation and for a certain defined period of time [5]. Pre-emptive therapy refers to detection of active CMV infection and initiation of treatment in advance of symptoms [10,11]. Targeted prophylaxis is the term I would use when giving selective prophylaxis to those who enter a high risk state [12].…”