在恩替卡韦联合替诺福韦联合治疗实现完全病毒抑制后采用替诺福韦单药治疗。

Tenofovir monotherapy after achieving complete viral suppression on entecavir plus tenofovir combination therapy.

作者信息

Kim Lily H, Chaung Kevin T, Ha Nghiem B, Kin Kevin C, Vu Vinh D, Trinh Huy N, Nguyen Huy A, Nguyen Mindie H

机构信息

aDivision of Gastroenterology and Hepatology, Stanford University Medical Center, Stanford, California, USA bPacific Health Foundation cSan Jose Gastroenterology, San Jose, California, USA.

出版信息

Eur J Gastroenterol Hepatol. 2015 Aug;27(8):871-6. doi: 10.1097/MEG.0000000000000368.

DOI:10.1097/MEG.0000000000000368

PMID:25919771

Abstract

OBJECTIVES

It is unclear whether patients with chronic hepatitis B with partial response to entecavir (ETV) who have achieved complete viral suppression (CVS) with ETV plus tenofovir (TDF) combination therapy maintain CVS if switched to TDF or ETV. Our goal was to examine virologic outcomes in such patients.

METHODS

This is a retrospective cohort study of 57 ETV partial responders with chronic hepatitis B who showed CVS on ETV+TDF combination therapy, who were switched back to monotherapy with either ETV (n=16) or TDF (n=18), or continued on combination therapy (n=23). The majority of patients were Asian (91%) and male (65%), with a mean age of 41±12 years.

RESULTS

The patients switched back to ETV had significantly higher rates of virologic breakthrough by 6 months after the switch compared with their TDF counterparts (88 vs. 39%, P=0.004). Patients who remained on ETV+TDF also had virologic breakthrough, due to either confirmed or suspected nonadherence. On multivariate analysis inclusive of age, sex, and hepatitis B virus DNA levels at initiation of combination therapy, ETV (compared with TDF) was found to be an independent predictor for virologic breakthrough (odds ratio 112.7, P=0.03), as well as duration of CVS of less than 12 months while on ETV+TDF (odds ratio 60.2, P=0.03).

CONCLUSION

TDF monotherapy, especially in those who have had CVS for at least 12 months on combination therapy, may be considered for some ETV partial responders who have achieved CVS with combination therapy, given the financial advantage and convenience of monotherapy.

摘要

目的

对于使用恩替卡韦（ETV）治疗部分应答的慢性乙型肝炎患者，若采用ETV联合替诺福韦（TDF）联合治疗实现了完全病毒学抑制（CVS），当换用TDF或ETV单药治疗时是否能维持CVS尚不清楚。我们的目标是研究此类患者的病毒学结局。

方法

这是一项回顾性队列研究，纳入57例ETV治疗部分应答的慢性乙型肝炎患者，这些患者在ETV + TDF联合治疗时实现了CVS，之后换用ETV（n = 16）或TDF（n = 18）单药治疗，或继续联合治疗（n = 23）。大多数患者为亚洲人（91%）且为男性（65%），平均年龄41±12岁。

结果

换用ETV的患者在换药后6个月时病毒学突破发生率显著高于换用TDF的患者（88% 对39%，P = 0.004）。继续使用ETV + TDF的患者也出现了病毒学突破，原因是确认或怀疑存在不依从。在纳入年龄、性别和联合治疗开始时的乙型肝炎病毒DNA水平的多因素分析中，发现ETV（与TDF相比）是病毒学突破的独立预测因素（比值比112.7，P = 0.03），也是在ETV + TDF治疗期间CVS持续时间少于12个月的独立预测因素（比值比60.2，P = 0.03）。