Differential Relapse Patterns After Discontinuation of Entecavir vs Tenofovir Disoproxil Fumarate in Chronic Hepatitis B,Clinical Gastroenterology and Hepatology

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Differential Relapse Patterns After Discontinuation of Entecavir vs Tenofovir Disoproxil Fumarate in Chronic Hepatitis B
Clinical Gastroenterology and Hepatology ( IF 11.6 ) Pub Date : 2022-07-19 , DOI: 10.1016/j.cgh.2022.07.005
Hannah S.J. Choi , Grishma Hirode , Chien-Hung Chen , Tung-Hung Su , Wai-Kay Seto , Stijn Van Hees , Margarita Papatheodoridi , Sabela Lens , Grace L.H. Wong , Sylvia M. Brakenhoff , Rong-Nan Chien , Jordan J. Feld , Milan J. Sonneveld , Henry L.Y. Chan , Xavier Forns , George V. Papatheodoridis , Thomas Vanwolleghem , Man-Fung Yuen , Yao-Chun Hsu , Jia-Horng Kao , Markus Cornberg , Bettina E. Hansen , Wen-Juei Jeng , Harry L.A. Janssen

Background and Aims

Whether entecavir (ETV) and tenofovir disoproxil fumarate (TDF) differentially affect relapse and outcomes following treatment discontinuation across different patient subpopulations remains unclear. We aimed to compare rates of off-therapy hepatitis B surface antigen (HBsAg) loss, virological and clinical relapse, and retreatment between chronic hepatitis B (CHB) patients who discontinued TDF or ETV therapy.

Methods

This study included 1402 virally suppressed CHB patients who stopped either ETV (n = 981) or TDF (n = 421) therapy between 2001 and 2020 from 13 participating centers across North America, Europe, and Asia. All patients were hepatitis B e antigen–negative at treatment discontinuation. Inverse probability of treatment weighting was used to balance the treatment groups. Outcomes were analyzed using survival methods.

Results

During a median off-treatment follow-up of 18 months, HBsAg loss occurred in 96 (6.8%) patients overall. Compared with ETV, TDF was associated with a higher rate of HBsAg loss (P = .03); however, the association was no longer significant after statistical adjustment (P = .61). Virological relapse occurred earlier among TDF-treated patients (P < .01); nonetheless, rates became comparable after the first year off therapy (P = .49). TDF was significantly associated with a higher clinical relapse rate than ETV throughout follow-up (P < .01). The development of a virological or clinical relapse did not affect the rate of HBsAg loss. Retreatment rates were not significantly different between the treatment groups.

Conclusions

TDF and ETV have differential relapse patterns but are associated with similar rates of HBsAg loss and retreatment following discontinuation. Finite therapy can be considered for CHB patients on either TDF or ETV therapy.

中文翻译：

慢性乙型肝炎患者停用恩替卡韦与富马酸替诺福韦地索普西后的不同复发模式

背景和目标

恩替卡韦 (ETV) 和富马酸替诺福韦二吡呋酯 (TDF) 是否对不同患者亚群停止治疗后的复发和结局有不同影响尚不清楚。我们旨在比较停止 TDF 或 ETV 治疗的慢性乙型肝炎 (CHB) 患者的停药乙型肝炎表面抗原 (HBsAg) 丢失率、病毒学和临床复发率以及再治疗率。

方法

这项研究包括 1402 名病毒抑制的 CHB 患者，他们在 2001 年至 2020 年期间停止了 ETV（n = 981）或 TDF（n = 421）治疗，来自北美、欧洲和亚洲的 13 个参与中心。所有患者在治疗停止时均为乙型肝炎 e 抗原阴性。使用治疗加权的逆概率来平衡治疗组。使用生存方法分析结果。

结果

在中位 18 个月的停药随访期间，96 名 (6.8%) 患者发生 HBsAg 消失。与 ETV 相比，TDF 与更高的 HBsAg 消失率相关 ( P = .03)；然而，这种关联在统计调整后不再显着 ( P = .61)。TDF 治疗的患者病毒学复发发生较早 ( P < .01)；尽管如此，在停止治疗的第一年后，发生率变得具有可比性 ( P = .49)。在整个随访期间，与 ETV 相比，TDF 与更高的临床复发率显着相关 ( P < .01)。病毒学或临床复发的发展并不影响 HBsAg 消失的速度。治疗组之间的再治疗率没有显着差异。