Background

In 2016, of the estimated 257 million people living with chronic hepatitis B virus (HBV) infection worldwide, only a small proportion was diagnosed and treated. The insufficiency of information on the proportion of people infected with HBV who are eligible for treatment limits the interpretation of global treatment coverage. We aimed to estimate the proportion of people with chronic HBV infection who were eligible for antiviral treatment worldwide, based on the WHO 2015 guidelines.

Methods

In this systematic review and meta-analysis, we searched Medline, EMBASE, and the Cochrane databases from Jan 1, 2007, to Jan 31, 2018, for studies describing HBsAg-positive people in the population or health-care facilities. We extracted information from published studies using a standardised form to estimate the frequency of cirrhosis, abnormal alanine aminotransferase (ALT), HBV DNA exceeding 2000 IU/mL or 20 000 IU/mL, presence of HBeAg, and eligibility for treatment as per WHO and other guidelines as reported in the studies. We pooled proportions through meta-analysis with random effects. The study was registered with PROSPERO, CRD42020132345.

Findings

Of the 13 497 studies, 162 were eligible and included in our analysis. These studies included 145 789 participants. The pooled estimate of the proportion of cirrhosis was 9% (95% CI 8–10), ranging from 6% (4–8) in community settings to 10% (9–11) in clinic settings. Examining the proportion of participants who had characteristics used to determine eligibility in the WHO guidelines, 1750 (10·1%) of 17 394 had HBV DNA exceeding 20 000 IU/mL, and 20 425 (30·8%) of 66 235 had ALT above the upper limit of normal. 32 studies reported eligibility for treatment according to WHO or any other guidelines, with a pooled estimate of eligibility at 19% (95% CI 18–20), ranging from 12% (6–18) for studies in community settings to 25% (19–30) in clinic settings.

Interpretation

Many studies described people with HBV infection, but few reported information in a way that allowed assessment of eligibility for treatment. Although about one in ten of the 257 million people with HBV infection (26 million) might be in urgent need of treatment because of cirrhosis, a larger proportion (12–25%) is eligible for treatment in accordance with different guidelines. Future studies describing people with HBV infection should report on treatment eligibility, according to broadly agreed definitions.

Funding

WHO and US Centers for Disease Control and Prevention.

中文翻译：

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估算全世界有资格接受乙型肝炎抗病毒治疗的慢性乙型肝炎病毒感染者的比例：系统评价和荟萃分析

背景

2016年，全球估计有2.57亿人患有慢性乙型肝炎病毒（HBV）感染，其中只有一小部分被诊断和治疗。关于有资格接受治疗的HBV感染者比例的信息不足，限制了对全球治疗覆盖率的解释。根据世界卫生组织2015年指南，我们旨在估算全球有资格接受抗病毒治疗的慢性HBV感染者的比例。

方法

在此系统的回顾和荟萃分析中，我们搜索了2007年1月1日至2018年1月31日期间的Medline，EMBASE和Cochrane数据库，以研究描述人群或医疗机构中HBsAg阳性的人的研究。我们使用标准化形式从已发表的研究中提取信息，以评估肝硬化的发生频率，异常的丙氨酸氨基转移酶（ALT），HBV DNA超过2000 IU / mL或20000 IU / mL，HBeAg的存在以及是否符合WHO和研究中报告的其他指南。我们通过荟萃分析汇总了具有随机效应的比例。该研究已在PROSPERO注册，注册号为CRD42020132345。

发现

在13 497项研究中，有162项符合条件并纳入了我们的分析。这些研究包括145789名参与者。合并肝硬化比例的估计值为9％（95％CI 8-10），范围从社区设置的6％（4-8）到临床设置的10％（9-11）。检查具有用于确定WHO准则资格的特征的参与者的比例，其中17 394个中的1750个（10·1％）的HBV DNA超过200000 IU / mL，66 235个中的20 425个（30·8％）的HBV DNA ALT高于正常上限。32项研究报告了根据WHO或任何其他准则的治疗资格，对合格率的综合估计为19％（95％CI 18-20），范围从在社区环境中进行研究的12％（6-18）到25％（ 19–30）。

解释

许多研究描述了患有HBV感染的人，但是很少报告能够评估治疗资格的信息。尽管2.57亿HBV感染者中有大约十分之一（2600万人）由于肝硬化而急需治疗，但仍有较大比例的人（12–25％）有资格根据不同的指南进行治疗。根据公认的定义，未来描述HBV感染者的研究应报告治疗资格。

资金

世卫组织和美国疾病预防控制中心。