Institute of Liver Studies, King's College Hospital, London, UK.
Aliment Pharmacol Ther. 2022 Sep;56(5):760-776. doi: 10.1111/apt.17105. Epub 2022 Jun 30.
Chronic hepatitis B remains a global health problem with an estimated 296 million people affected worldwide. Individuals are at risk of serious complications such as cirrhosis and hepatocellular carcinoma and accurately predicting these clinical endpoints has proven difficult. However, several viral biomarkers have recently been developed, including quantitative HBV surface antigen (qHBsAg), hepatitis B RNA (HBV RNA) and core-related antigen (HBcrAg), and shown promise in a range of clinical settings.
To critically appraise these novel biomarkers, exploring their potential uses, availability of assays and areas for future development.
We performed a literature search of PubMed, identifying articles published in the field of hepatitis B biomarkers between 2010 and 2022.
Novel biomarkers such as HBcrAg, HBV RNA and qHBsAg may be useful in predicting treatment outcomes, stratifying the risk of future complications and estimating off-treatment viral reactivation. Furthermore, HBV RNA and HBcrAg titres may accurately reflect cccDNA transcriptional activity, and this is particularly informative in the context of nucleoside analogue therapy. On a cautionary note, most studies have been performed in Caucasian or Asian populations, and methods for detecting HBV RNA lack standardisation.
Novel viral biomarkers have the potential to provide additional insights into the natural history of infection and allow a more bespoke, cost-effective framework of care. However, access remains limited, and further efforts are needed to validate their use in ethnically diverse populations, confirm predictive cut-off values, and establish their role in the era of novel antiviral therapies.
慢性乙型肝炎仍是一个全球性的健康问题，全球估计有 2.96 亿人受到影响。个体面临肝硬化和肝细胞癌等严重并发症的风险，准确预测这些临床终点一直很困难。然而，最近已经开发出几种病毒生物标志物，包括定量乙型肝炎表面抗原（qHBsAg）、乙型肝炎 RNA（HBV RNA）和核心相关抗原（HBcrAg），并在一系列临床环境中显示出前景。
批判性地评价这些新型生物标志物，探讨其潜在用途、检测方法的可用性以及未来的发展方向。
我们在 PubMed 上进行了文献检索，确定了 2010 年至 2022 年期间发表的乙型肝炎生物标志物领域的文章。
新型生物标志物，如 HBcrAg、HBV RNA 和 qHBsAg，可能有助于预测治疗结果、分层未来并发症的风险和估计治疗结束后病毒的再激活。此外，HBV RNA 和 HBcrAg 滴度可能准确反映 cccDNA 转录活性，这在核苷酸类似物治疗的背景下特别有意义。需要注意的是，大多数研究都是在白种人或亚洲人群中进行的，HBV RNA 的检测方法缺乏标准化。
新型病毒生物标志物有可能为感染的自然史提供更多的见解，并允许建立更具针对性、更具成本效益的护理框架。然而，获得这些标志物的途径仍然有限，需要进一步努力验证它们在种族多样化人群中的使用、确认预测临界值，并确定它们在新型抗病毒治疗时代的作用。
