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。作者: StephenW 时间: 2022-11-27 21:34
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.