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法国 AFEF/ANRS CO22 Hepather 队列中,替诺福韦和恩替卡韦治疗的乙型肝炎慢性感染患者 5 年内 HCC 发生率相似。

Similar 5-year HCC occurrence in Tenofovir- and Entecavir-treated HBV chronic infection in the French AFEF/ANRS CO22 Hepather cohort.

机构信息

Assistance Publique - Hôpitaux de Paris, Hôpital Cochin, Unité d'Hépatologie, Paris, France.

Université Paris Descartes, INSERM U-1223, Institut Pasteur, Paris, France.

出版信息

Aliment Pharmacol Ther. 2021 Mar;53(5):616-629. doi: 10.1111/apt.16197. Epub 2021 Jan 19.

Abstract

BACKGROUND

Chronic hepatitis B virus (HBV) infection results in a high risk of cirrhosis and its complications, cirrhosis decompensation (DC), hepatocellular carcinoma (HCC), liver transplantation (LT), death or any of these outcomes (composite endpoint [CE]). Nucleos(t)ide analogues (NUCs) such as tenofovir or entecavir are associated with a reduction in these complications.

AIM

To compare the impact of tenofovir and entecavir on these outcomes in patients treated for HBV infection and included in the prospective Hepather cohort.

METHODS

All patients with HBV infection who had received tenofovir or entecavir for more than 6 months at or after entry in the ANRS CO22 cohort were selected. Patients with HDV and HCV co-infection or prior liver event were excluded. Incidence rates of events were compared using inverse probability of treatment weighting (IPW).

RESULTS

The cohort included 1800 patients (986 tenofovir and 814 entecavir). Median follow-up was 4.2 years. The incidences of HCC, DC, LT, ACD, LRD and CE were not different between tenofovir- (1.8 (0.9; 3.2), 0.6 (0.2; 1.6), 0.2 (0.0; 0.8), 1.7 (0.8; 3.0), 0.8 (0.2, 1.8) and 4.1 (3.0; 5.4) per 1000 person-years) and entecavir-treated patients (1.6 (0.7; 3.0), 0.7 (0.2; 1.8), 0.2 (0.0; 1.0), 3.0 (1.7, 4.8), 0.5 (0.1; 1.5) and 5.0 (3.3; 7.2)) per 1000 person-years, respectively.

CONCLUSION

The risk of liver-related events or death was not different between tenofovir- and entecavir-treated patients in this large prospective cohort of predominantly non-cirrhotic French patients.

TRIAL REGISTRATION NUMBER

NCT019553458.

摘要

背景

慢性乙型肝炎病毒(HBV)感染会导致肝硬化及其并发症、肝硬化失代偿(DC)、肝细胞癌(HCC)、肝移植(LT)、死亡或这些结局的任何组合(复合终点 [CE])的发生风险升高。核苷(酸)类似物(NUC)如替诺福韦或恩替卡韦与这些并发症的减少相关。

目的

比较替诺福韦和恩替卡韦在接受乙型肝炎病毒感染治疗并纳入前瞻性 Hepather 队列的患者中的这些结局的影响。

方法

选择在 ANRS CO22 队列入组时或之后接受替诺福韦或恩替卡韦治疗超过 6 个月的所有 HBV 感染患者。排除合并丁型肝炎病毒和丙型肝炎病毒感染或既往肝脏事件的患者。使用逆概率治疗加权(IPW)比较事件发生率。

结果

该队列包括 1800 名患者(替诺福韦组 986 例,恩替卡韦组 814 例)。中位随访时间为 4.2 年。替诺福韦组和恩替卡韦组 HCC、DC、LT、ACD、LRD 和 CE 的发生率分别为 1.8(0.9;3.2)、0.6(0.2;1.6)、0.2(0.0;0.8)、1.7(0.8;3.0)、0.8(0.2,1.8)和 4.1(3.0;5.4)/1000 人年,而恩替卡韦组分别为 1.6(0.7;3.0)、0.7(0.2;1.8)、0.2(0.0;1.0)、3.0(1.7,4.8)、0.5(0.1;1.5)和 5.0(3.3;7.2)/1000 人年。

结论

在这项大型前瞻性法国非肝硬化患者队列研究中,替诺福韦组和恩替卡韦组患者的肝脏相关事件或死亡风险无差异。

试验注册编号

NCT019553458。

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