恩替卡韦或替诺福韦停药后丙酚替诺福韦、恩替卡韦和富马酸替诺福韦二吡呋酯的再治疗疗效及肾脏安全性

Retreatment Efficacy and Renal Safety of Tenofovir Alafenamide, Entecavir, and Tenofovir Disoproxil Fumarate After Entecavir or Tenofovir Cessation.

作者信息

Chiu Shao-Ming, Chang Kuo-Chin, Hu Tsung-Hui, Hung Chao-Hung, Wang Jing-Houng, Lu Sheng-Nan, Chen Chien-Hung

机构信息

Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, 123 Ta Pei Road, Kaohsiung, Taiwan.

出版信息

Dig Dis Sci. 2023 Feb;68(2):665-675. doi: 10.1007/s10620-022-07657-8. Epub 2022 Aug 17.

DOI:10.1007/s10620-022-07657-8

PMID:35976597

Abstract

BACKGROUND

We aimed to compare the one-year retreatment efficacy and renal safety of entecavir, tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF) after HBV relapse in patients who discontinued entecavir or TDF.

METHODS

This retrospective study included 289 chronic hepatitis B (CHB) patients without cirrhosis who received entecavir (n = 93), TDF (n = 103), or TAF (n = 86) retreatment for at least 12 months after entecavir or TDF cessation.

RESULTS

The rate of virological response (HBV DNA < 20 IU/mL) at 12 months of retreatment was 79/93 (84.9%) in the entecavir group, 92/103 (89.3%) in the TDF group, and 72/86 (83.7%) in the TAF group. The rate of ALT normalization (ALT ≤ 40 U/L) after 12 months of retreatment was 76/93 (81.7%) in the entecavir group, 77/103 (74.7%) in the TDF group , and 73/86 (84.9%) in the TAF group. There was no significant difference in the rates of virological response (p = 0.495) and ALT normalization (p = 0.198) among the three groups. Multivariate analysis showed that lower HBV DNA and HBsAg levels at baseline were independently associated with virological response at 12 months of retreatment. The TDF group (37.8 ± 34.8 U/L) had higher ALT levels at 12 months of retreatment than the TAF (27. ± 17.9 U/L, p = 0.015) and entecavir (28.3 ± 19.3 U/L, p = 0.022) groups. In patients with eGFR 60-90 mL/min/1.73 m, eGFR change between baseline and 12 months of retreatment increased in the entecavir and TAF groups and decreased in the TDF group.

CONCLUSIONS

TAF could be one of the retreatment options for retreatment of HBV relapse after entecavir or TDF cessation.

摘要

背景

我们旨在比较恩替卡韦、富马酸替诺福韦二吡呋酯（TDF）和替诺福韦艾拉酚胺（TAF）在停用恩替卡韦或TDF的患者乙肝复发后一年的再治疗疗效及肾脏安全性。

方法

这项回顾性研究纳入了289例无肝硬化的慢性乙型肝炎（CHB）患者，这些患者在停用恩替卡韦或TDF后接受恩替卡韦（n = 93）、TDF（n = 103）或TAF（n = 86）再治疗至少12个月。

结果

再治疗12个月时的病毒学应答率（HBV DNA＜20 IU/mL）在恩替卡韦组为79/93（84.9%），TDF组为92/103（89.3%），TAF组为72/86（83.7%）。再治疗12个月后ALT正常化率（ALT≤40 U/L）在恩替卡韦组为76/93（81.7%），TDF组为77/103（74.7%），TAF组为73/86（84.9%）。三组间病毒学应答率（p = 0.495）和ALT正常化率（p = 0.198）无显著差异。多因素分析显示，基线时较低的HBV DNA和HBsAg水平与再治疗12个月时的病毒学应答独立相关。TDF组在再治疗12个月时的ALT水平（37.8±34.8 U/L）高于TAF组（27.±17.9 U/L，p = 0.015）和恩替卡韦组（28.3±19.3 U/L，p = 0.022）。在估算肾小球滤过率（eGFR）为60 - 90 mL/min/1.73 m²的患者中，恩替卡韦组和TAF组基线至再治疗12个月时的eGFR变化增加，TDF组则降低。