Department of Infectious Disease, CHU Lille, University of Lille, Lille, France.
U1019-UMR 9017-Center for Infection and Immunity of Lille, INSERM, Centre National de la Recherche Scientifique, Institut Pasteur de Lille, University of Lille, Lille, France.
Blood Adv. 2023 Mar 14;7(5):856-865. doi: 10.1182/bloodadvances.2022008667.
Letermovir is the first approved drug for cytomegalovirus (CMV) infection prophylaxis in adult patients who are CMV positive undergoing allogeneic hematopoietic cell transplantation (allo-HCT). Because CMV infection risk varies from patient to patient, we evaluated whether a risk-based strategy could be effective. In this single-center study, all consecutive adult patients who were CMV positive and underwent allo-HCT between 2015 and 2021 were included. During period 1 (2015-2017), letermovir was not used, whereas during period 2 (2018-2021), letermovir was used in patients at high risk but not in patients at low risk, except in those receiving corticosteroids. In patients at high risk, the incidence of clinically significant CMV infection (csCMVi) in period 2 was lower than that in period 1 (P < .001) by week 14 (10.5% vs 51.6%) and week 24 (16.9% vs 52.7%). In patients at low risk, although only 28.6% of patients received letermovir in period 2, csCMVi incidence was also significantly lower (P = .003) by week 14 (7.9% vs 29.0%) and week 24 (11.2% vs 33.3%). Among patients at low risk who did not receive letermovir (n = 45), 23 patients (51.1%) experienced transient positive CMV DNA without csCMVi, whereas 17 patients (37.8%) experienced negative results. In both risk groups, the 2 periods were comparable for CMV disease, overall survival, progression-free survival, relapse, and nonrelapse mortality. We concluded that a risk-based strategy for letermovir use is an effective strategy which maintains the high efficacy of letermovir in patients at high risk but allows some patients at low risk to not use letermovir.
来特莫韦是首个获批用于 CMV 阳性接受异基因造血细胞移植(allo-HCT)的成年患者的 CMV 感染预防的药物。由于 CMV 感染风险因患者而异,我们评估了基于风险的策略是否有效。在这项单中心研究中,纳入了 2015 年至 2021 年间所有连续的 CMV 阳性且接受 allo-HCT 的成年患者。在第 1 期(2015-2017 年)期间,未使用来特莫韦,而在第 2 期(2018-2021 年)期间,仅在高风险患者中使用来特莫韦,而在低风险患者中不使用,除非患者正在接受皮质类固醇治疗。在高风险患者中,第 2 期的临床显著 CMV 感染(csCMVi)发生率在第 14 周(10.5%比 51.6%)和第 24 周(16.9%比 52.7%)时低于第 1 期(P<0.001)。在低风险患者中,尽管只有 28.6%的患者在第 2 期接受了来特莫韦,但 csCMVi 的发生率也显著降低(P=0.003),第 14 周(7.9%比 29.0%)和第 24 周(11.2%比 33.3%)时的发生率更低。在未接受来特莫韦治疗的低风险患者(n=45)中,23 例(51.1%)患者的 CMV DNA 一过性阳性但无 csCMVi,17 例(37.8%)患者的 CMV DNA 结果为阴性。在两个风险组中,第 1 期和第 2 期的 CMV 疾病、总生存、无进展生存、复发和非复发死亡率无差异。我们得出结论,基于风险的来特莫韦使用策略是一种有效的策略,该策略可维持来特莫韦在高风险患者中的高疗效,同时允许一些低风险患者不使用来特莫韦。