一项前瞻性随机队列研究显示，在接受替诺福韦酯富马酸富

StephenW

Medicine (Baltimore). 2020 May;99(18):e19907. doi: 10.1097/MD.0000000000019907.
Consolidation period of 18 months no better at promoting off-treatment durability in HBeAg-positive chronic hepatitis B patients with tenofovir disoproxil fumarate treatment than a 12-month period: A prospective randomized cohort study.
Wang CH1, Chang KK1, Lin RC1, Kuo MJ1, Yang CC2, Tseng YT3.
Author information

1
    Department of Hepatogastroenterology, Tainan Municipal Hospital (Managed by Show Chwan Medical Care Corporation), Tainan.
2
    Department of Hepatogastroenterology, Show Chwan Memorial Hospital, Changhua.
3
    Committee of Medical Research, Tainan Municipal Hospital (Managed by Show Chwan Medical Care Corporation), Tainan, Taiwan.

Abstract

There has been no clear consensus on the optimal consolidation periods following HBeAg seroconversion (SC) in HBeAg-positive chronic hepatitis B (CHB) patients. Our study aimed to prospectively compare relapse rates between 12 months' and 18 months' consolidation periods to see whether or not there is beneficial durability of tenofovir disoproxil fumarate (TDF) therapy with longer consolidation periods.We enrolled a total of 137 HBeAg-positive Asian CHB patients treated with TDF monotherapy. Forty-six patients achieved HBeAg SC. Then, they were randomly assigned to consolidation period of either 12 months (group A) or 18 months (group B). After stopping TDF therapy, all patients were followed up for 12 months.Thirteen patients (56.5%) relapsed in group A and 12 patients (52.2%) relapsed in group B after 12 months' follow-up (P = .958). Pretreatment HBsAg level is the only significant predictor for off-therapy recurrence by univariate analysis (P = .024). Baseline HBeAg >1000 S/CO in group B patients were significantly less likely to relapse than those of group A (P = .046). Baseline alanine aminotransferase (ALT) >133 U/L could significantly predict occurrence of HBeAg SC (P = .008; 95% CI: 0.545-0.763; AUC: 0.654).Overall, a prolonged consolidation period has no positive effect on TDF therapy on sustained viral suppression in HBeAg-positive Asian CHB patients. However, a prolonged consolidation period was beneficial to patients with high baseline semi-quantitative HBeAg levels in terms of off-treatment durability. Baseline ALT > 133 U/L could significantly predict the occurrence of HBeAg SC.

PMID:
    32358357
DOI:
    10.1097/MD.0000000000019907

StephenW

医学（巴尔的摩）。 2020年5月； 99（18）：e19907。 Doi：10.1097 / MD.0000000000019907。
一项前瞻性随机队列研究显示，在接受替诺福韦酯富马酸富马酸治疗的慢性乙型肝炎HBeAg阳性慢性乙型肝炎患者中，巩固期为18个月没有比12个月更好。
王CH1，张KK1，林RC1，郭MJ1，杨CC2，曾YT3。
作者信息

1个
台南市台南市医院消化内科（由秀泉医疗公司管理）。
2
彰化昭秀纪念医院肝肠胃科。
3
台南市立医院医学研究委员会（由Show Chwan Medical Care Corporation管理），台湾台南。

抽象

对于HBeAg阳性慢性乙型肝炎（CHB）患者，HBeAg血清转化（SC）后的最佳巩固期尚无明确共识。我们的研究旨在前瞻性比较12个月和18个月巩固期之间的复发率，以观察具有更长巩固期的替诺福韦富马酸替诺福韦（TDF）疗法是否具有有益的持久性。我们共纳入了137例接受TDF单药治疗的HBeAg阳性亚洲CHB患者。 46例患者达到了HBeAg SC。然后，将他们随机分配为12个月（A组）或18个月（B组）的合并期。停止TDF治疗后，所有患者均获随访12个月。随访12个月，A组复发13例（56.5％），B组复发12例（52.2％）（P = .958）。单因素分析表明，治疗前HBsAg水平是治疗后复发的唯一重要预测指标（P = .024）。 B组患者的基线HBeAg> 1000 S / CO较A组明显降低（P = .046）。基线丙氨酸氨基转移酶（ALT）> 133 U / L可以显着预测HBeAg SC的发生（P = 0.008; 95％CI：0.545-0.763; AUC：0.654）。总体而言，延长巩固期对HBeAg阳性亚洲CHB患者的TDF治疗持续抑制病毒没有积极作用。然而，就治疗后的持久性而言，延长巩固期对基线高半定量HBeAg水平的患者有利。基线ALT> 133 U / L可以显着预测HBeAg SC的发生。

PMID：
32358357
DOI：
10.1097 / MD.0000000000019907

StephenW

https://journals.lww.com/md-jour ... o_better_at.19.aspx