Genomics Research Center, Academia Sinica, Taipei, Taiwan.
Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.
Hepatology. 2016 Aug;64(2):381-9. doi: 10.1002/hep.28552. Epub 2016 Apr 15.
Serum levels of hepatitis B virus (HBV) DNA (≤2000 IU/mL) and hepatitis B surface antigen (HBsAg) (<1000 IU/mL) have been shown to distinguish inactive carriers with high accuracy. The goal of this study was to validate the predictability of one-time measurement of quantitative HBsAg and HBV DNA levels for inactive carrier status and chronic hepatitis B (CHB) progression in a community-based cohort. This study included 1529 participants chronically infected with HBV genotype B or C from the REVEAL-HBV cohort. They were ascertained as inactive or active CHB after 18 months of follow-up. Validity of the one-time measurement was assessed by sensitivity, specificity, and receiver operating characteristic curves, while associations with clinical outcomes were calculated with Cox proportional hazards regressions. The one-time baseline measurement of HBsAg <1000 IU/mL and HBV DNA <2000 IU/mL distinguished inactive carriers from active CHB with a sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy of 71%, 85%, 83%, 74%, and 78%, respectively. Those identified as inactive carriers using the one-time baseline measurement had multivariate adjusted hazard ratios of 0.36 (95% confidence interval [CI], 0.20-0.63) and 0.36 (0.23-0.56) for hepatocellular carcinoma and liver cirrhosis, respectively, and an adjusted rate ratio of 6.97 (95% CI, 5.21-9.33) for HBsAg seroclearance. Areas under the receiver operating characteristic curve of predicting these outcomes using the one-time definition were similar to those obtained when using long-term follow-up defined carrier status for prediction.
This study confirms the predictability of a one-time combined HBsAg and HBV DNA measurement for future inactive carriers. This single-point strategy provides new and complementary information useful for management of patients with chronic hepatitis B infection. (Hepatology 2016;64:381-389).
已有研究表明，乙型肝炎病毒（HBV）DNA 血清水平（≤2000IU/mL）和乙型肝炎表面抗原（HBsAg）（<1000IU/mL）可准确区分非活动型携带者。本研究旨在验证在基于社区的队列中，单次测量 HBsAg 和 HBV DNA 定量水平对非活动型携带者状态和慢性乙型肝炎（CHB）进展的预测能力。该研究纳入了来自 REVEAL-HBV 队列的 1529 名慢性感染乙型肝炎病毒基因型 B 或 C 的患者。经过 18 个月的随访，他们被确定为非活动型或活动型 CHB。通过敏感性、特异性和受试者工作特征曲线评估单次测量的有效性，同时通过 Cox 比例风险回归计算与临床结果的相关性。HBsAg<1000IU/mL 和 HBV DNA<2000IU/mL 的单次基线测量可将非活动型携带者与活动型 CHB 区分开来，其敏感性、特异性、阳性预测值、阴性预测值和诊断准确性分别为 71%、85%、83%、74%和 78%。使用单次基线测量确定为非活动型携带者的患者，其肝癌和肝硬化的多变量调整后的危险比分别为 0.36（95%置信区间 [CI]，0.20-0.63）和 0.36（0.23-0.56），HBsAg 血清学清除的调整后率比为 6.97（95%CI，5.21-9.33）。使用一次性定义预测这些结果的受试者工作特征曲线下面积与使用长期随访定义的携带者状态进行预测时获得的面积相似。
本研究证实了单次联合 HBsAg 和 HBV DNA 测量对未来非活动型携带者的预测能力。这种单点策略提供了新的、有用的补充信息，有助于慢性乙型肝炎感染患者的管理。（《肝脏病学》2016 年；64:381-389）
