在核苷（t）ide结束时将乙型肝炎核心相关和表面抗原相结合

StephenW

Aliment Pharmacol Ther. 2018 Nov 19. doi: 10.1111/apt.15058. [Epub ahead of print]
Combining hepatitis B core-related and surface antigens at end of nucleos(t)ide analogue treatment to predict off-therapy relapse risk.
Hsu YC1,2,3,4, Nguyen MH5, Mo LR6, Wu MS7, Yang TH8, Chen CC7, Tseng CH3, Tai CM3, Wu CY9, Lin JT1,2, Tanaka Y10, Chang CY1,2,3.
Author information

1
    Division of Gastroenterology and Hepatology, Fu-Jen Catholic University Hospital, New Taipei, Taiwan.
2
    School of Medicine, Fu-Jen Catholic University, New Taipei, Taiwan.
3
    Division of Gastroenterology and Hepatology, E-Da Hospital, Kaohsiung, Taiwan.
4
    Graduate Institute of Clinical Medical Science, China Medical University, Taichung, Taiwan.
5
    Division of Gastroenterology and Hepatology, Stanford University Medical Center, Palo Alto, California.
6
    Department of Internal Medicine, Tainan Municipal Hospital, Tainan, Taiwan.
7
    Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
8
    Division of Gastroenterology, Department of Medicine, Lotung Poh-Ai Hospital, Yilan, Taiwan.
9
    Faculty of Medicine and Graduate Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan.
10
    Department of Virology and Liver Unit, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.

Abstract
BACKGROUND:

There remains an unmet need for convenient biomarkers to assess the risks of discontinuing nucleos(t)ide analogues (NAs) in chronic hepatitis B (CHB).
AIM:

To investigate if hepatitis B core-related antigen (HBcrAg) is an independent of surface antigen (HBsAg) for risk prediction of NA cessation.
METHODS:

This prospective multicentre study enrolled 135 CHB patients who stopped entecavir or tenofovir after achieving viral remission for a median of 25.2 months. All patients stopped NA with negative HBeAg and undetectable viral DNA, and were then observed for clinical relapse and HBsAg loss. Predictors including HBsAg and HBcrAg levels were explored using Cox proportional hazard model and weighted to develop a risk score.
RESULTS:

During a median follow-up of 25.9 months, clinical relapse and HBsAg loss occurred in 66 and eight patients, respectively, with a 5-year cumulative incidence of 56.1% (95% CI 46.7-66.0%) and 8.8% (95% CI 4.3-17.4%), respectively. HBcrAg was an independent relapse predictor, as well as HBsAg, age, ALT and tenofovir use. A score (SCALE-B) was calculated by the equation of 35*HBsAg (log IU/mL) + 20*HBcrAg (log U/mL) + 2*age (year) + ALT (U/L) + 40 for tenofovir use. The concordance rates for clinical relapse were 0.87, 0.88, 0.87, 0.85 and 0.90 at 1, 2, 3, 4 and 5 years, respectively. Moreover, HBsAg loss occurred exclusively in low-risk patients predicted by the score.
CONCLUSIONS:

Serum HBcrAg and HBsAg levels were independent predictors of off-NA relapse and can be factored into a risk score to guide treatment cessation in patients with CHB.

© 2018 John Wiley & Sons Ltd.

PMID:
    30450681
DOI:
    10.1111/apt.15058

StephenW

Aliment Pharmacol Ther。 2018年11月19日doi：10.1111 / apt.15058。 [提前打印]
在核苷（t）ide结束时将乙型肝炎核心相关和表面抗原相结合，以预测治疗后复发风险。
Hsu YC1,2,3,4，Nguyen MH5，Mo LR6，Wu MS7，Yang TH8，Chen CC7，Tseng CH3，Tai CM3，Wu CY9，Lin JT1,2，Tanaka Y10，Chang CY1,2,3。
作者信息

1
    台湾新北市辅仁天主教大学医院消化内科和肝病科。
2
    台湾新北市辅仁天主教大学医学院。
3
    台湾高雄市E-Da医院消化内科和肝病科。
4
    中国医科大学临床医学研究所，台湾台中。
五
    加利福尼亚州帕洛阿尔托斯坦福大学医学中心消化内科和肝病学系。
6
    台湾台南市立医院内科
7
    台湾台北大学医院内科
8
    台湾宜兰县Lotung Poh-Ai医院医学科消化内科
9
    台湾台北国立阳明大学医学院临床医学研究所。
10
    日本名古屋市名古屋市立大学医学研究科病毒学与肝科。

抽象
背景：

对方便的生物标志物仍然存在未满足的需求，以评估在慢性乙型肝炎（CHB）中停止核苷（酸）类似物（NAs）的风险。
目标：

调查乙型肝炎核心相关抗原（HBcrAg）是否独立于表面抗原（HBsAg）用于NA停止的风险预测。
方法：

这项前瞻性多中心研究纳入了135例CHB患者，这些患者在达到病毒缓解后停用恩替卡韦或替诺福韦，中位数为25.2个月。所有患者均停用NA，HBeAg阴性，病毒DNA检测不到，随后观察临床复发和HBsAg丢失情况。使用Cox比例风险模型探索包括HBsAg和HBcrAg水平的预测因子并加权以产生风险评分。
结果：

在25.9个月的中位随访期间，66例和8例患者分别出现临床复发和HBsAg丢失，5年累积发生率为56.1％（95％CI 46.7-66.0％）和8.8％（95％CI）分别为4.3-17.4％）。 HBcrAg是一种独立的复发预测因子，以及HBsAg，年龄，ALT和替诺福韦的使用。对于替诺福韦，通过35 * HBsAg（log IU / mL）+ 20 * HBcrAg（log U / mL）+ 2 *年龄（年）+ ALT（U / L）+ 40的等式计算得分（SCALE-B）使用。临床复发的一致率分别为1年，2年，3年，4年和5年分别为0.87,0.88,0.87,0.85和0.90。此外，HBsAg丢失仅发生在由分数预测的低风险患者中。
结论：

血清HBcrAg和HBsAg水平是非NA复发的独立预测因子，可以作为指导CHB患者停止治疗的风险评分。

©2018 John Wiley＆Sons Ltd.

结论：
    30450681
DOI：
    10.1111 / apt.15058