AASLD2020[161]快速HBSAG下降代替了HBSAG绝对水平 可以基于社区预

StephenW

161
RAPID HBSAG DECLINE INSTEAD OF HBSAG ABSOLUTE LEVEL
CAN PREDICT HBSAG CLEARANCE IN COMMUNITY-BASED
UNTREATED CHRONIC HEPATITIS B COHORT
Hsin-Che Lin1, Jessica Liu2, Mei-Hung Pan1, Wen-
Juei Jeng3, Hwai-I Yang1 and REVEAL-HBV team, (1)
Genomics Research Center, Academia Sinica, (2)Perinatal
Epidemiology and Health Outcomes Research Unit, Division
of Neonatology, Department of Pediatrics, School of Medicine,
Stanford University and Lucile Packard Children’s Hospital,
Palo Alto, California, (3)Department of Gastroenterology and
Hepatology, Chang Gung Memorial Hospital, Linkou Branch,
Taiwan
Background: Spontaneous HBsAg clearance is regarded as
functional cure and the ultimate therapeutic endpoint in chronic
hepatitis B patients Previous tertiary hospital-based studies
have shown HBsAg decline >0.5 log10IU/mL in one year or >1
log10IU/mL in two years accompanied by absolute HBsAg level
<200 IU/mL can predict surface antigen clearance However,
they have not yet been validated by a community-based
cohort with relatively unstringent follow-up schedule This
study aimed to validate previous algorithms in a communitybased
cohort Methods: Participants from the REVEAL-HBV
cohort (n=4155) who had 3 or more quantitative HBsAg data
within 5 years prior to HBsAg clearance or patient’s last visit
were included Serum qHBsAg level was measured using
Roche Elecsys HBsAg II quant assay (range, 0 05–52,000 IU/
mL; Roche Diagnostics, Mannheim, Germany) Rapid HBsAg
decline was defined as HBsAg decline >0.5 log10IU/mL in 1
year or >1 log10IU/mL in 2 years. Sensitivity, specificity, PPV
and NPV were used to assess the performance on predicting
HBsAg clearance Statistic procedures were performed with
SAS 9.4. P-value less than .05 was considered significant.
Results: Among 707 CHB participants who met the inclusion
criteria, 41 participants achieved surface antigen clearance
during a median of 10 7 years follow-up The age at the entry
of the cohort [mean ±SD: 44 36±8 89 years vs 45 02±10 5
years; p=0 6465] and gender [male: 77 18% vs 78 05%; p=0
8972] between subjects with and without HBsAg clearance
were comparable The HBsAg levels in the clearance group
at all different time points were significantly lower (p<0.0001)
compared to the non-clearance group and the HBsAg decline
rate was greater [0 43 (0-0 72) vs 0 04 (-0 02-0 12) log10IU
/mL/year, p<0 0001] Similar to previous studies, combining
HBsAg level <200 IU/ml and a decline rate of 0 5 log10IU /
ml/year as a prediction algorithm (Sensitivity=0 4412,
Specificity=0.9792, PPV=0. 5172, NPV=0.972) showed
fairly good Specificity and NPV. Furthermore, using HBsAg
decline rate of 0 5 log10IU/ml/year alone achieved non-inferior
(Sensitivity=0.4412, Specificity=0.9792, PPV=0. 5172,
NPV=0 972) to the models of combining HBsAg decline rate
and HBsAg level Conclusion: HBsAg decline rate of 0 5
log10IU /mL/year alone can be used as a practical predictor for
HBsAg clearance in routine practice.

StephenW

161
快速HBSAG下降代替了HBSAG绝对水平
可以基于社区预测HBSAG清除
未经治疗的慢性乙型肝炎队列
林新澈1，刘J洁2，潘美红1，文文
Jeng Jeng3，Hwai-I Yang1和REVEAL-HBV团队，（1）
中国科学院基因组研究中心，（2）围产期
流行病学和健康成果研究组
医学院儿科新生儿科
斯坦福大学和露西尔·帕卡德儿童医院
加利福尼亚州帕洛阿尔托，（3）消化内科
长口纪念医院林口分院肝病科
台湾
背景：自发性HBsAg清除被认为是
慢性功能性治愈和最终治疗终点
乙肝患者以前基于三级医院的研究
已显示一年中HBsAg下降> 0.5 log10IU / mL或> 1
两年内log10IU / mL，并伴有绝对HBsAg水平
<200 IU / mL可以预测表面抗原清除率，但是，
他们尚未通过基于社区的验证
队列相对宽松的队列
旨在验证基于社区的先前算法的研究
队列方法：REVEAL-HBV的参与者
具有3个或更多定量HBsAg数据的队列（n = 4155）
在HBsAg清除或患者最后一次就诊前5年内
血清qHBsAg水平用
Roche Elecsys HBsAg II定量测定法（范围，0 05–52,000 IU /
毫升; Roche Diagnostics，德国曼海姆）快速HBsAg
下降定义为HBsAg下降> 0.5 log10IU / mL
一年或2年内> 1 log10IU / mL。敏感性，特异性，PPV
和NPV用于评估预测的效果
进行HBsAg清除统计程序
SAS 9.4。小于0.05的P值被认为是重要的。
结果：在707名CHB参与者中，他们被纳入
标准，41位参与者达到了表面抗原清除
在10 7年的中位数随访期间入院年龄
队列[平均±SD：44 36±8 89岁vs 45 02±10 5
年份; p = 0 6465]和性别[男：77 18％vs 78 05％； p = 0
[8972]有和没有HBsAg清除的受试者之间
清除组中的HBsAg水平相当
在所有不同时间点均显着降低（p <0.0001）
与非清除组相比，HBsAg下降
速率更大[0 43（0-0 72）vs 0 04（-0 02-0 12）log10IU
/ mL / year，p <0 0001]与先前的研究类似，
HBsAg水平<200 IU / ml，下降速度为0 5 log10IU /
毫升/年作为预测算法（灵敏度= 4412，
特异性＝ 0.9792，PPV ＝ 0。 5172，NPV = 0.972）显示
相当好的特异性和NPV。此外，使用HBsAg
单独达到0 5 log10IU / ml /年的下降率
（灵敏度= 0.4412，特异性= 0.9792，PPV =5。5172，
NPV = 0 972）结合HBsAg下降率模型
和HBsAg水平的结论：HBsAg下降率为0 5
单独的log10IU / mL /年可作为
在常规实践中清除HBsAg。