长期使用核苷酸（NA）模拟疗法治疗慢性HBV感染患者的血清HBV

StephenW

J Clin Gastroenterol

. 2020 Jun 26.
doi: 10.1097/MCG.0000000000001376. Online ahead of print.
Serum HBV RNA Dynamic and Drug Withdrawal Predictor Value in Patients With Chronic HBV Infection on Long-term Nucleos(t)ide Analogue (NA) Therapy
Yayun Liu  1 , Jianya Xue  1 , Wei Liao  1 , Hongli Yan  2 , Xuesong Liang  1
Affiliations
Affiliations

    1
    Departments of Infectious Diseases.
    2
    Reproductive Medicine Center, Changhai Hospital, Second Military Medical University, Shanghai, China.

    PMID: 32604147 DOI: 10.1097/MCG.0000000000001376

Abstract

Aims: This study aimed to investigate the dynamic pattern of serum hepatitis B virus (HBV) RNA in chronic hepatitis B (CHB) patients on long-term nucleos(t)ide analogue (NA) therapy and evaluate predictor value of end-of-treatment (EOT) serum HBV RNA status on drug-withdrawal durability.

Methods: We carried out a real-life cohort study of 326 CHB patients on NA treatment between February 12, 2016 and February 21, 2018. Thirty of these patients discontinued NA treatment after enrollment, and were included in 2-year off-therapy follow-up. Serum HBV RNA levels were determined using the RNA simultaneous amplification testing method.

Results: Both serum HBV RNA and DNA levels declined significantly in long-term antiviral progress. When the treatment duration was longer than 3 years, the undetectable rates of HBV RNA and DNA were 55.10% and 97.0%, respectively. The serum HBV RNA-negative rate was 39.5%. The cumulative 2-year off-therapy viral and clinical relapse rate was 40.56%; 95% confidence interval (95% CI), 21.51-59.61 and 31.31%; 95% CI, 11.32-51.29 in all patients, respectively. Patients with EOT hepatitis B surface antigen (HBsAg)≤1000 IU/mL plus HBV RNA negativity had a relatively lower cumulative 2-year off-therapy viral relapse rate (23.01%; 95% CI, 0.17-45.99). EOT HBsAg≤1000 IU/mL plus HBV RNA negativity showed obvious superiority for the EOT HBsAg≤1000 IU/mL single in drug withdrawal durability prediction, with better specificity (18.18% vs. 72.73%, P=0.03), and the positive predictive value and negative predictive value were 76.92% and 47.06%, respectively.

Conclusions: In the long-term antiviral process, both serum HBV RNA and DNA levels declined significantly. EOT serum HBV RNA negativity was not an independent drug withdrawal marker, but can complement the HBsAg titer to monitor drug withdrawal in CHB patients on long-term NA therapy.

StephenW

临床胃肠病杂志

。 2020年6月26日。
doi：10.1097 / MCG.0000000000001376。在线印刷。
长期使用核苷酸（NA）模拟疗法治疗慢性HBV感染患者的血清HBV RNA动态和停药预测值
刘亚云1，薛建亚1，廖伟1，严洪利2，梁雪松1
隶属关系
隶属关系

    1个
    传染病科。
    2
    第二军医大学附属长海医院生殖医学中心，上海

    PMID：32604147 DOI：10.1097 / MCG.0000000000001376

抽象

目的：本研究旨在调查长期接受核苷酸（t）类似物（NA）治疗的慢性乙型肝炎（CHB）患者血清乙型肝炎病毒（HBV）RNA的动态模式，并评估预后的预测价值治疗（EOT）血清HBV RNA状态对戒断持续时间的影响。

方法：我们在2016年2月12日至2018年2月21日之间对326名CHB患者进行NA治疗进行了真实的队列研究。这些患者中有30名患者入选后中断了NA治疗，并纳入了2年的非治疗随访-向上。使用RNA同时扩增测试方法确定血清HBV RNA水平。

结果：在长期抗病毒治疗中，血清HBV RNA和DNA含量均显着下降。当治疗时间超过3年时，HBV RNA和DNA的检出率分别为55.10％和97.0％。血清HBV RNA阴性率为39.5％。治疗后2年累计病毒和临床复发率为40.56％； 95％置信区间（95％CI），21.51-59.61和31.31％；所有患者的CI分别为95％，11.32-51.29。 EOT乙型肝炎表面抗原（HBsAg）≤1000IU / mL加上HBV RNA阴性的患者具有相对较低的2年累计非治疗性病毒复发率（23.01％； 95％CI，0.17-45.99）。 EOTHBsAg≤1000IU / mL加上HBV RNA阴性显示，单药EOTHBsAg≤1000IU / mL在停药持久性预测上具有明显优势，特异性更高（18.18％vs. 72.73％，P = 0.03），且阳性预测值和阴性预测值分别为76.92％和47.06％。

结论：在长期的抗病毒过程中，血清HBV RNA和DNA水平均显着下降。 EOT血清HBV RNA阴性不是独立的停药标志物，但可以补充HBsAg滴度来监测长期NA治疗的CHB患者的停药情况。