Real-world effectiveness of preemptive therapy (PET) for cytomegalovirus (CMV) disease prevention in CMV high-risk donor seropositive/recipient seronegative (D+R-) liver transplant recipients (LTxR).
Real-world effectiveness of preemptive therapy (PET) for cytomegalovirus (CMV) disease prevention in CMV high-risk donor seropositive/recipient seronegative (D+R-) liver transplant recipients (LTxR).
复制标题
超前治疗 (PET) 对巨细胞病毒 (CMV) 疾病预防在 CMV 高危供体血清阳性/受者血清阴性 (DR-) 肝移植受者 (LTxR) 中的真实效果。
DOI：
10.1111/tid.14015
复制
发表时间：
2023
期刊：
影响因子：
--
通讯作者：
Limaye,AjitP
中科院分区：
文献类型：
--
作者：
Doss,KathleenM;Kling,CatherineE;Heldman,MadeleineR;Singh,Nina;Wagener,Marilyn;Rakita,RobertM;Fisher,CynthiaE;Limaye,AjitP
背景尽管在 CMV D+R- 肝移植受者 (LTxR) 的 CAPSIL 随机试验中，先发性治疗 (PET) 与预防巨细胞病毒 (CMV) 疾病的普遍预防相比具有优越性，但由于对 PET 可行性的后勤考虑，实际效果可能较低。方法我们在 50 名连续接受第一次肝脏移植的成人 CMV D+R- LTxR 中回顾性评估了 PET 作为单一移植中心的标准临床护理我们对 2019 年 4 月 4 日至 2021 年 5 月 18 日期间进行的移植进行了比较，并与 CAPSIL 研究中随机接受 PET 的患者的结果和依从性进行了比较（N = 100）。主要结局是 CMV 疾病，次要结局是活检证实的急性同种异体移植排斥、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。探索性结果包括病毒学参数和遵守方案指定的 CMV qPCR 监测的措施。结果各组之间的基线特征相似。在现实世界和 CAPSIL 队列中，移植后 1 年 CMV 疾病的累积发病率分别为 4/50 (8%) 和 9/100 (9%)，p = 1.0。 100 天 PET 期间 CMV 疾病突破率较低（2/50 [4%]），与 CAPSIL 研究的 PET 队列相似（3/100 [3%]）。 所有次要和探索性结果在真实世界和 CAPSIL PET 队列之间没有显着差异。结论在这项首次报道的真实世界 PET 研究中，CMV D+R-LTxR 中 CMV 疾病预防和其他临床结果的可行性和有效性与临床试验中 PET 报告的相似。需要进行额外的研究来确认在其他情况下的可行性和普遍性。
BackgroundDespite 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.MethodsWe 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.ResultsBaseline 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.ConclusionsIn 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.
登录
查看更多内容
影响因子：
13.6
作者：
Luan, Fu L.;Stuckey, Linda J.;Ojo, Akinlolu
通讯作者：
Ojo, Akinlolu
影响因子：
168.9
作者：
Emery, VC;Sabin, CA;Griffiths, PD
通讯作者：
Griffiths, PD
影响因子：
6.2
作者：
W. Kim;A. Badley;R. Wiesner;M. Porayko;E. Seaberg;M. Keating;R. Evans;E. Dickson;R. Krom;C. Payá
通讯作者：
C. Payá
基于实时测量肝移植受者病毒载量的巨细胞病毒的先发性治疗。
影响因子：
1.5
作者：
Hsin;T. Cacciarelli;M. Wagener;Nina Singh
通讯作者：
Nina Singh
影响因子：
6.2
作者：
J. McCarthy;M. Karim;H. Krueger;P. Keown
通讯作者：
P. Keown