Doss Kathleen M, Kling Catherine E, Heldman Madeleine R, Singh Nina, Wagener Marilyn, Rakita Robert M, Fisher Cynthia E, Limaye Ajit P
Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, Washington, USA.
Division of Transplant Surgery, Department of Surgery, University of Washington, Seattle, Washington, USA.
Transpl Infect Dis. 2023 Apr;25(2):e14015. doi: 10.1111/tid.14015. Epub 2023 Feb 3.
Despite superiority of preemptive therapy (PET) compared to universal prophylaxis for prevention of cytomegalovirus (CMV) disease in the CAPSIL randomized trial among CMV D+R- liver transplant recipients (LTxRs), real-world effectiveness may be lower because of logistical concerns about feasibility of PET.
We retrospectively assessed PET as standard clinical care at a single transplant center among 50 consecutive adult CMV D+R- LTxRs undergoing a first liver transplant between 4/4/2019 and 5/18/2021 and compared outcomes and adherence to those randomized to PET in the CAPSIL study (N = 100). The primary outcome was CMV disease and secondary outcomes were biopsy-confirmed acute allograft rejection, retransplant, invasive fungal infections, and death, all assessed by 1-year post-transplant. Exploratory outcomes included virologic parameters and measures of adherence to protocol-specified CMV qPCR monitoring.
Baseline characteristics were similar between groups. The cumulative incidence of CMV disease at 1-year post-transplant was 4/50 (8%) versus 9/100 (9%) in the real-world and CAPSIL cohorts, respectively, p = 1.0. The rate of breakthrough CMV disease during the 100-day PET period was low (2/50 [4%]) and similar to the PET cohort from the CAPSIL study (3/100 [3%]). All secondary and exploratory outcomes were not significantly different between the real-world and CAPSIL PET cohorts.
In this first reported study of real-world PET, the feasibility and effectiveness for CMV disease prevention and for other clinical outcomes in CMV D+R- LTxRs were similar to those reported with PET in a clinical trial. Additional studies to confirm feasibility and generalizability in other settings are warranted.
在针对巨细胞病毒（CMV）血清学阳性/受体血清学阴性（CMV D+R-）肝移植受者（LTxRs）的CAPSIL随机试验中，与普遍预防相比，抢先治疗（PET）在预防CMV疾病方面具有优势，但由于PET可行性的后勤问题，其在现实世界中的有效性可能较低。
我们回顾性评估了在一个移植中心将PET作为标准临床护理措施应用于2019年4月4日至2021年5月18日期间连续接受首次肝移植的50例成年CMV D+R- LTxRs的情况，并将结果及依从性与CAPSIL研究中随机接受PET治疗的患者（N = 100）进行比较。主要结局是CMV疾病，次要结局包括活检证实的急性移植物排斥反应、再次移植、侵袭性真菌感染和死亡，所有这些均在移植后1年进行评估。探索性结局包括病毒学参数以及对方案规定的CMV定量聚合酶链反应（qPCR）监测的依从性测量。
两组之间的基线特征相似。在现实世界队列和CAPSIL队列中，移植后1年CMV疾病的累积发生率分别为4/50（8%）和9/100（9%），p = 1.0。在100天PET期间，CMV疾病突破性发作的发生率较低（2/50 [4%]），与CAPSIL研究的PET队列（3/100 [3%]）相似。现实世界队列和CAPSIL PET队列之间的所有次要和探索性结局均无显著差异。
在这项首次报道的关于现实世界中PET的研究中，CMV D+R- LTxRs预防CMV疾病及其他临床结局的可行性和有效性与临床试验中PET的报道相似。有必要进行更多研究以证实其在其他环境中的可行性和可推广性。
