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异体造血细胞移植受者中使用乐韦莫韦预防巨细胞病毒感染的临床“真实世界”经验。

Clinical "real-world" experience with letermovir for prevention of cytomegalovirus infection in allogeneic hematopoietic cell transplant recipients.

机构信息

Sylvester Comprehensive Cancer Center, Miami, FL, USA.

University of Miami Miller School of Medicine, Miami, FL, USA.

出版信息

Clin Transplant. 2020 Jul;34(7):e13866. doi: 10.1111/ctr.13866. Epub 2020 Apr 19.

DOI:10.1111/ctr.13866
PMID:32242979
Abstract

BACKGROUND

Letermovir was approved in 2017 for prevention of cytomegalovirus (CMV) infection in seropositive (R+) allogeneic hematopoietic cell transplantation (HCT) patients. Post-marketing data with this new agent are scarce.

METHODS

We compared the incidence of both CMV reactivation (any viremia) and clinically significant CMV infection (CS-CMVi; CMV DNAemia leading to preemptive treatment or presence of CMV tissue invasive disease) at days +100 and +200 post-HCT in 25 adult allogeneic HCT patients who received letermovir prophylaxis (until day 100) and a historical control group of 106 CMV R+ allogeneic HCT recipients who underwent CMV preemptive therapy.

RESULTS

CMV reactivation within 100 days post-HCT was lower in the letermovir group vs control group (20% vs 72% respectively, P < .001). The 100-day cumulative incidence of CS-CMVi was significantly lower in the letermovir group vs control group (4% vs 59% respectively, P < .001). Significantly reduced incidence of CMV reactivation and CS-CMVi was also observed at 200 days in the letermovir group. No difference in mortality was observed between the two groups.

CONCLUSION

This study confirms the efficacy of letermovir in preventing CMV reactivation in CMV R+ allogeneic HCT recipients in first 100 days post-HCT and suggests sustained efficacy after discontinuation of prophylaxis.

摘要

背景

来特莫韦于 2017 年获批用于预防 CMV(巨细胞病毒)感染血清阳性(R+)异基因造血细胞移植(HCT)患者。该新药物的上市后数据较少。

方法

我们比较了 25 例接受来特莫韦预防(至第 100 天)的成年异基因 HCT 患者和 106 例接受 CMV 预防治疗的 CMV R+异基因 HCT 受者在移植后第 100 天和第 200 天的 CMV 再激活(任何病毒血症)和临床显著 CMV 感染(CS-CMVi;CMV DNAemia 导致抢先治疗或存在 CMV 组织侵袭性疾病)的发生率。

结果

来特莫韦组移植后 100 天内 CMV 再激活的发生率低于对照组(分别为 20%和 72%,P<0.001)。来特莫韦组与对照组相比,第 100 天的 CS-CMVi 的累积发生率显著降低(分别为 4%和 59%,P<0.001)。来特莫韦组在第 200 天也观察到 CMV 再激活和 CS-CMVi 的发生率显著降低。两组死亡率无差异。

结论

这项研究证实了来特莫韦在预防 CMV R+异基因 HCT 受者移植后 100 天内 CMV 再激活方面的疗效,并提示在预防治疗停止后仍有持续疗效。

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