A Randomized Study of Quantiferon-CMV-Directed Versus Fixed Duration Valganciclovir Prophylaxis to Reduce Late CMV Following Lung Transplantation.
Westall GP, Cristiano Y, et al.Transplantation, 2018; [record in progress].
Aims
To assess whether QuantiFERON-CMV (QFN-CMV) assay-directed antiviral prophylaxis is more effective than standard of care (SOC) prophylaxis at reducing the incidence of late CMV infection/reactivation within the lung allograft.
Interventions
SOC was continuing CMV prophylaxis for 5 months following lung transplantation (LTx). At 5 months following LTx, patients were randomized (1:2) to either cessation of antiviral prophylaxis (SOC) or variable length QuantiFERON-CMV (QFN-CMV) assay-directed antiviral prophylaxis.
Participants
Adult lung transplant recipients at risk of CMV infection (n = 118; QFN-CMV-directed prophylaxis n = 83, SOC, n = 36).
Outcomes
The primary outcome measure was the difference in the incidence of CMV infection (>600 copies/ml) in the lung allograft within 18 months of transplant in patients at-risk of CMV reactivation. CMV infection was defined as detection of nucleic acid in the bronchoalveolar lavage. Secondary outcomes included CMV viremia in the blood, acute cellular rejection, chronic allograft dysfunction and death within 18 months of therapy.
Follow-up
Up to 18 months post transplantation
CET Conclusions
This single-centre study investigates the role of targeted CMV prophylaxis using the Quantiferon (QFN) CMV assay to predict those at risk following lung transplantation. Patients were randomized to standard 5-month valganciclovir prophylaxis, or variable-duration prophylaxis determined by response to the QFN assay. The study found that incidence of CMV infection (on BAL) was significantly reduced with QFN-directed prophylaxis, with no difference in CMV viraemia or other endpoints. This is an interesting study and the results suggest that adaptation of the duration of prophylaxis by monitoring CMV immunity is a reasonable strategy. Future studies should determine whether this approach is cost-effective, and whether these findings translate to other transplant types.
Data analysis
Per protocol analysis
Trial registration
Australian Clinical Research Network - ACTRN - 12612000551897.