He Dengming, Guo Shimin, Chen Wen, Chen Xianli, Yan Guohua, Wang Jie, Li Maoshi, Zhu Peng, Huang Hongfei, Wang Yuming
Institute of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chongqing, China.
BMC Infect Dis. 2013 Oct 3;13:458. doi: 10.1186/1471-2334-13-458.
Hepatitis B e Antigen (HBeAg)-negative chronic hepatitis B (CHB) patients have an active liver disease with a high risk of progression to decompensated cirrhosis and hepatocellular carcinoma. The management strategy for HBeAg-negative CHB patients treated with nucleos(t)ide analogues (NUCs) is a topic of concern. To observe the outcomes for this population after NUCs withdrawal, HBeAg-negative CHB patients with loss of hepatitis B surface antigen (HBsAg) or sustained undetectable HBV DNA levels who had discontinued NUCs therapy were included in the study.
A total of 66 patients (2 patients with HBsAg loss and 64 patients with sustained undetectable HBV DNA levels) were examined. HBV DNA levels and alanine aminotransferase (ALT) levels were monitored regularly after discontinuation of NUCs therapy. Relapse was defined as HBV DNA levels >2,000 IU/mL while off therapy in at least two determinations more than 4 weeks apart.
The time to achieve undetectable HBV DNA levels was 14 weeks (interquartile range (IQR): 12-24 weeks). The time until consolidation therapy was 144 weeks (IQR: 96-168 weeks). No relapses occurred in either of the HBsAg loss patients. Among the 64 patients with undetectable HBV DNA levels, 19 (29.7%) patients demonstrated evidence of relapse. All the relapses occurred within 96 weeks after discontinuation. The median duration of relapse was 36 weeks (IQR: 12-48 weeks). Elevation of HBV DNA and ALT levels over baseline was only observed in 10% of the relapse patients. There were no significant differences among the baseline characteristics (sex, HBV genotype, age, or ALT level) or the time until consolidation therapy between relapse and sustained-response patients.
NUC discontinuation is feasible after achieving undetectable HBV DNA levels in HBeAg-negative CHB patients. Prolonging the time until consolidation therapy may be a good strategy to decrease the rate of relapse. More than 96 weeks of sustained response is a predictive marker of long-term sustained response.
乙肝e抗原（HBeAg）阴性的慢性乙型肝炎（CHB）患者存在活动性肝病，进展为失代偿期肝硬化和肝细胞癌的风险较高。核苷（酸）类似物（NUC）治疗HBeAg阴性CHB患者的管理策略是一个备受关注的话题。为观察该人群停用NUC后的结局，本研究纳入了已停用NUC治疗且乙肝表面抗原（HBsAg）消失或HBV DNA水平持续检测不到的HBeAg阴性CHB患者。
共检查了66例患者（2例HBsAg消失患者和64例HBV DNA水平持续检测不到的患者）。停用NUC治疗后定期监测HBV DNA水平和丙氨酸氨基转移酶（ALT）水平。复发定义为在停药后至少两次间隔超过4周的检测中，HBV DNA水平>2000 IU/mL。
达到HBV DNA检测不到水平的时间为14周（四分位间距（IQR）：12 - 24周）。巩固治疗前的时间为144周（IQR：96 - 168周）。HBsAg消失的患者均未复发。在64例HBV DNA水平检测不到的患者中，19例（29.7%）出现复发证据。所有复发均发生在停药后96周内。复发的中位持续时间为36周（IQR：12 - 48周）。仅10%的复发患者出现HBV DNA和ALT水平高于基线的情况。复发患者与持续应答患者在基线特征（性别、HBV基因型、年龄或ALT水平）或巩固治疗前时间方面无显著差异。
在HBeAg阴性CHB患者的HBV DNA水平检测不到后停用NUC是可行的。延长巩固治疗前的时间可能是降低复发率的良好策略。持续应答超过96周是长期持续应答的预测指标。
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