QuantiFERON-CMV Cell-Mediated Immunity to Predict Post-Prophylaxis CMV Disease in D+/R- Kidney Transplant Recipients (Phase 3 Letermovir vs Valganciclovir Trial)
A blood test of CMV-specific immunity measured at the end of antiviral prophylaxis was poor at predicting which high-risk kidney transplant patients would later develop CMV disease.
Background
CMV-specific cell-mediated immunity may help individualize prevention after kidney transplantation. This study assessed how CMV-CMI evolves post-transplant and whether QuantiFERON-CMV at the end of prophylaxis predicts post-prophylaxis CMV disease in the highest-risk D+/R- recipients.
Study design
Within a phase 3, double-blind trial, 601 adult CMV D+/R- recipients received letermovir or valganciclovir prophylaxis for 28 weeks. QuantiFERON-CMV was performed centrally at transplant and weeks 12, 28, and 52, and test performance for predicting CMV disease through week 52 was evaluated.
Key findings
Positive QuantiFERON-CMV rose over time (1.2% at baseline to 28.9% at week 52). Post-prophylaxis CMV disease occurred in 18.3%. The week-28 assay showed sensitivity 8.3%, specificity 94.3%, PPV 87.5%, and NPV 17.5%, with similar results across letermovir and valganciclovir arms.
Clinical implications
Because most recipients who developed CMV disease had negative or indeterminate end-of-prophylaxis results, QuantiFERON-CMV alone had limited clinical utility for risk-stratifying post-prophylaxis monitoring in D+/R- recipients.
Category
Transplant
Source
Clinical Infectious Diseases
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