Solera Javier T, Ferreira Victor H, Cervera Carlos, Hosseini-Moghaddam Seyed M, Gill John, Shalhoub Sarah, Zaltzman Jeff, Kumar Deepali, Humar Atul
Ajmera Transplant Center, University Health Network, Toronto, ON, Canada.
Division of Infectious Diseases, University of Alberta, Edmonton, AB, Canada.
Transplantation. 2025 Mar 1;109(3):527-535. doi: 10.1097/TP.0000000000005173. Epub 2024 Aug 20.
There are few interventional studies using CMV cell-mediated immunity (CMI) to guide antiviral prophylaxis. We assessed the Quantiferon-CMV (QTF-CMV) assay to guide CMV prophylaxis duration in high-risk organ transplant recipients.
A single-arm, multicenter, prospective interventional study including high-risk kidney, pancreas, liver, and heart transplant recipients who were either donor CMV-seropositive, recipient-seronegative (D + /R - ) or recipient-seropositive with antithymocyte globulin (R + /ATG) induction. CMI testing was performed using the QTF-CMV assay at months 3, 4, 5, and 6 posttransplant. Prophylaxis was discontinued for a positive CMI but continued for a negative result up to a maximum of 6 mo. The primary endpoint was CMV viremia ≥1000 IU/mL up to 1 y posttransplant.
One hundred eight patients were included, comprising kidney (n = 89), kidney-pancreas (n = 7), liver (n = 10), and heart (n = 2) transplants. Eighty-nine patients (82.4%) completed the study protocol (n = 39 D + /R - and n = 50 R + /ATG). In the D + /R - group, only 1 of 39 patients (2.6%) had a positive QTF-CMV result. In the R + /ATG group, 33 of 50 patients (66%) had a positive QTF-CMV result before 6 mo, allowing for early discontinuation of prophylaxis (28 at month 3, 4 at month 4, and 1 at month 5). During the follow-up, CMV viremia ≥1000 IU/mL occurred in only 4 of 33 patients (12.1%) who discontinued prophylaxis early compared with 6 of 17 patients (35.3%) with negative QTF-CMV results and continued prophylaxis (hazard ratio 0.31; 95% confidence interval, 0.09-1.09; P = 0.07). No R + patient developed CMV disease.
QTF-CMV-guided prophylaxis appears useful in R + patients who may benefit from a tailored duration of prophylaxis. This strategy does not appear to be useful in D + /R - patients.
使用巨细胞病毒（CMV）细胞介导免疫（CMI）指导抗病毒预防的干预性研究较少。我们评估了全血γ干扰素释放试验检测巨细胞病毒（QTF-CMV）以指导高危器官移植受者的CMV预防持续时间。
一项单臂、多中心、前瞻性干预性研究，纳入高危肾、胰腺、肝和心脏移植受者，这些受者要么是供者CMV血清学阳性、受者血清学阴性（D + /R - ），要么是接受抗胸腺细胞球蛋白诱导的受者血清学阳性（R + /ATG）。在移植后第3、4、5和6个月使用QTF-CMV检测进行CMI检测。CMI检测结果为阳性则停止预防，但结果为阴性则继续预防，最长持续6个月。主要终点是移植后1年内CMV病毒血症≥1000 IU/mL。
共纳入108例患者，包括肾移植（n = 89）、肾-胰腺联合移植（n = 7）、肝移植（n = 10）和心脏移植（n = 2）。89例患者（82.4%）完成了研究方案（n = 39例D + /R - 和n = 50例R + /ATG）。在D + /R - 组中，39例患者中只有1例（2.6%）QTF-CMV检测结果为阳性。在R + /ATG组中，50例患者中有33例（66%）在6个月前QTF-CMV检测结果为阳性，从而可以提前停止预防（3个月时28例，4个月时4例，5个月时1例）。在随访期间，与17例QTF-CMV检测结果为阴性并继续预防的患者中有6例（35.3%）发生CMV病毒血症≥1000 IU/mL相比，提前停止预防的33例患者中只有4例（12.1%）发生（风险比0.31；95%置信区间，0.09 - 1.09；P = 0.07）。没有R + 患者发生CMV疾病。
QTF-CMV指导的预防似乎对可能从量身定制的预防持续时间中获益的R + 患者有用。该策略对D + /R - 患者似乎无用。
