恩替卡韦与富马酸替诺福韦二吡呋酯在国际队列中功能性治

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恩替卡韦与富马酸替诺福韦二吡呋酯在国际队列中功能性治愈慢性乙型肝炎的有效性

    Yao-Chun Hsu, Dae Won Jun, Cheng-Yuan Peng, Ming-Lun Yeh, Huy Trinh, Grace Lai-Hung Wong, Sung Eun Kim, Chien-Hung Chen, Hyunwoo Oh, Chia-Hsin Lin, Lindsey Trinh, Vincent Wai -Sun Wong、Eilleen Yoon、Sang Bong Ahn、Daniel Huang、Yong Kyun Cho、Jae Yoon Jeong、Soung Won Jeong、Hyoung Su Kim、Qing Xie、Li Liu、Mar Riveiro-Barciela、Pei-Chien Tsai、Elena Vargas Accarino、 …Mindie H. Nguyen

国际肝病学第 16 卷，第 1297–1307 页（2022 年）引用这篇文章

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介绍

恩替卡韦 (ETV) 和富马酸替诺福韦二吡呋酯 (TDF) 都是慢性乙型肝炎 (CHB) 的一线疗法，但它们在乙型肝炎表面抗原 (HBsAg) 血清学清除方面的比较有效性仍不清楚。
方法

这项国际多中心队列研究从 10 个国家或地区的 23 个中心招募了 7697 名初治 CHB 患者（中位年龄 50 岁；男性 66.75%），开始接受 ETV (n = 5430) 或 TDF (n = 2267)，没有基线恶性肿瘤或免疫抑制地区。观察患者的 HBsAg 血清学清除直至死亡、失访或治疗中断或转换。 HBsAg 血清学清除的发生率根据竞争死亡率进行了调整，并通过治疗加权逆概率 (IPTW) 和多变量回归分析在 ETV 和 TDF 队列之间进行了比较。
结果

研究人群的中位随访时间为 56.1 个月，观察时间为 36,929 人次，每人年观察 11 人。 70 名接受 ETV 治疗的患者和 21 名接受 TDF 治疗的患者出现 HBsAg 血清学清除，ETV 的 8 年累积发生率为 1.69%（95% 置信区间 [CI] 1.32–2.17），1.34%（95% CI 0.85–2.10%） , 对于 TDF (p = 0.58)。在 IPTW 分析中，两个研究队列的背景协变量更加平衡，TDF 与 ETV 的 HBsAg 血清学清除的年龄校正风险比 (HR) 为 0.91（95% CI 0.50–1.64；p = 0.75）。此外，在多变量竞争风险回归模型中，两种药物之间没有显着差异（TDF 与 ETV 的调整后亚分布 HR 为 0.92；95% CI 0.56–1.53；p = 0.76）。
结论

ETV 和 TDF 在 HBsAg 血清学清除的发生率上没有显着差异，这两种方案都很少发生。

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Effectiveness of entecavir vs tenofovir disoproxil fumarate for functional cure of chronic hepatitis B in an international cohort

    Yao-Chun Hsu, Dae Won Jun, Cheng-Yuan Peng, Ming-Lun Yeh, Huy Trinh, Grace Lai-Hung Wong, Sung Eun Kim, Chien-Hung Chen, Hyunwoo Oh, Chia-Hsin Lin, Lindsey Trinh, Vincent Wai-Sun Wong, Eilleen Yoon, Sang Bong Ahn, Daniel Huang, Yong Kyun Cho, Jae Yoon Jeong, Soung Won Jeong, Hyoung Su Kim, Qing Xie, Li Liu, Mar Riveiro-Barciela, Pei-Chien Tsai, Elena Vargas Accarino, …Mindie H. Nguyen 

Hepatology International volume 16, pages 1297–1307 (2022)Cite this article

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Abstract
Introduction

Both entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are first-line therapies for chronic hepatitis B (CHB), but their comparative effectiveness with regards to hepatitis B surface antigen (HBsAg) seroclearance remains unclear.
Methods

This international multicenter cohort study enrolled 7697 treatment-naïve CHB patients (median age 50 years; male 66.75%) initiated on either ETV (n = 5430) or TDF (n = 2267) without baseline malignancy or immunosuppression from 23 centers across 10 countries or regions. Patients were observed for HBsAg seroclearance until death, loss to follow-up, or treatment discontinuation or switching. The incidences of HBsAg seroclearance were adjusted for competing mortality and compared between ETV and TDF cohorts with inverse probability of treatment weighting (IPTW) and also by multivariable regression analysis.
Results

The study population was followed up for a median duration of 56.1 months with 36,929 11 person-years of observation. HBsAg seroclearance occurred in 70 ETV-treated and 21 TDF-treated patients, yielding 8-year cumulative incidence of 1.69% (95% confidence interval [CI] 1.32–2.17) for ETV and 1.34% (95% CI 0.85–2.10%), for TDF (p = 0.58). In the IPTW analysis with the two study cohorts more balanced in background covariates, the age-adjusted hazard ratio (HR) of TDF versus ETV for HBsAg seroclearance was 0.91 (95% CI 0.50–1.64; p = 0.75). Furthermore, there was no significant difference between the two medications in the multivariable competing risk regression model (adjusted sub-distributional HR 0.92 for TDF vs. ETV; 95% CI 0.56–1.53; p = 0.76).
Conclusions

ETV and TDF did not differ significantly in the incidence of HBsAg seroclearance, which rarely occurred with either regimen.