Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
Division of Gastroenterology and Hepatology, National University Health System, Singapore, Singapore.
Dig Dis. 2023;41(1):115-123. doi: 10.1159/000526933. Epub 2022 Sep 7.
A substantial number of patients who do not meet treatment criteria for chronic hepatitis B (CHB) later develop adverse outcomes such as cirrhosis and hepatocellular carcinoma (HCC). Our aim was to determine whether current practice guidelines adequately identify CHB patients who will benefit from antiviral therapy.
We performed a retrospective cohort study comparing the incidence of adverse liver outcomes (cirrhosis and/or HCC) in untreated treatment-ineligible (at baseline and throughout follow-up) versus treated treatment-eligible patients according to standard American Association for the Study of Liver Diseases (AASLD) 2018 guidance (alanine aminotransferase [ALT] >70/50 U/L for men/women plus hepatitis B virus [HBV] DNA >20,000/2,000 IU/mL for HBeAg+/-) and with a sensitivity analyses using a lower threshold (ALT >40 U/L and HBV DNA >2,000 IU/mL).
We reviewed records of 5,840 patients from 5 clinics in California and identified 2,987 treatment-naive non-HCC CHB patients. Of those, 271 patients remained untreated treatment-ineligible, 514 patients were treatment-eligible and initiated treatment, with 5-year cumulative adverse liver incidences of 12.5% versus 7.2%, p = 0.074. On multivariable analysis adjusting for age, sex, diabetes, albumin, platelet count, and HBV DNA, compared to treated treatment-eligible patients, untreated treatment-ineligible patients had a significantly higher risk of adverse liver outcomes (adjusted hazard ratio: 2.38, 95% confidence interval 1.03-5.48, p = 0.04) in main analysis by AASLD 2018 criteria but not in sensitivity analysis using the lower treatment threshold (p = 0.09).
Patients never meeting standard AASLD 2018 criteria for antiviral therapy and never treated had twice the risk of developing cirrhosis and/or HCC when compared to eligible and treated patients.
大量不符合慢性乙型肝炎（CHB）治疗标准的患者后来出现了肝硬化和肝细胞癌（HCC）等不良结局。我们的目的是确定当前的实践指南是否充分识别出将从抗病毒治疗中获益的 CHB 患者。
我们进行了一项回顾性队列研究，比较了根据美国肝病研究协会（AASLD）2018 年标准（男性谷丙转氨酶[ALT]＞70/50 U/L 加乙型肝炎病毒[HBV]DNA＞20,000/2,000 IU/mL 对于 HBeAg+/-），未接受治疗的治疗不合格（基线和整个随访期间）与接受治疗的治疗合格患者相比，未接受治疗的治疗不合格患者（ALT＞70/50 U/L 加乙型肝炎病毒[HBV]DNA＞20,000/2,000 IU/mL 对于 HBeAg+/-）和使用较低阈值（ALT＞40 U/L 和 HBV DNA＞2,000 IU/mL）进行的敏感性分析，发生不良肝脏结局（肝硬化和/或 HCC）的发生率。
我们回顾了加利福尼亚州 5 家诊所的 5840 名患者的记录，确定了 2987 名未经治疗的非 HCC CHB 患者。其中，271 名患者仍未接受治疗，治疗不合格，514 名患者为治疗合格并开始治疗，5 年累积不良肝脏发生率分别为 12.5%和 7.2%，p=0.074。在校正年龄、性别、糖尿病、白蛋白、血小板计数和 HBV DNA 后，多变量分析显示，与治疗合格的患者相比，未治疗的治疗不合格患者发生不良肝脏结局的风险显著更高（调整后的危险比：2.38，95%置信区间 1.03-5.48，p=0.04）根据 AASLD 2018 标准进行的主要分析，但在使用较低治疗阈值的敏感性分析中则没有（p=0.09）。
从未符合抗病毒治疗标准的 AASLD 2018 标准的患者和从未接受过治疗的患者相比，发展为肝硬化和/或 HCC 的风险是合格且接受治疗的患者的两倍。
