Hepatitis B virus (HBV) elimination requires expanding and decentralising HBV care services. However, peripheral health facilities lack access to diagnostic tools to assess eligibility for antiviral therapy. Through the Hepatitis B in Africa Collaborative Network (HEPSANET), we aimed to develop and evaluate a score using tests generally available at lower-level facilities, to simplify the evaluation of antiviral therapy eligibility in people living with HBV. We surveyed the availability of clinical and laboratory parameters across different health-care levels in sub-Saharan Africa. We used data from the HEPSANET dataset, the largest cross-sectional dataset of treatment-naive people living with HBV in sub-Saharan Africa, to derive and validate the score. Participants from this dataset were included in the analysis if they were aged 18 years or older and had liver fibrosis stages determined by a liver stiffness measurement or liver histopathology. Participants with co-infections or metabolic disorders were excluded. We allocated participants to the derivation and validation sets by geographical site. In the derivation set, we used stepwise logistic regression to identify the best performing parameters for identifying participants that met the 2017 European Association for the Study of the Liver (EASL) criteria. Regression coefficients were converted into integer points to construct simplified algorithms for different health-care levels. In the validation set, we estimated the area under the receiver operating characteristic, sensitivity, and specificity of the simplified algorithm for identifying antiviral therapy eligibility defined by the 2017 EASL criteria. At 11 sites from eight countries that returned surveys, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and platelet count were generally available at district hospital levels, and hepatitis B e antigen and point-of-care HBV DNA tests were available only at regional and provincial hospital levels or above. Among 2895 participants included from the HEPSANET database (1740 [60·1%] male, 1155 [39·9%] female), 409 (14·1%) met EASL antiviral therapy eligibility criteria. In the derivation set, the optimal district-level hospital score was: ALT (IU/L), less than 40 (0 points), 40–79 (+1), 80 or greater (+2); AST (IU/L), less than 40 (0), 40–79 (+1), 80 or greater (+2); and platelet counts (10/L), less than 100 (+2), 100–149 (+1), 150 or greater (0). When combined with family history and clinical data for decompensated cirrhosis that do not require any biological tests, a cut-off of 2 points or more had a sensitivity and specificity of 82% (95% CI 76–86) and 95% (93–96) to identify treatment-eligible individuals in the derivation set, and 78% (71–85) and 87% (86–89) in the validation set, respectively. Using a score incorporating platelet counts, AST, and ALT, the majority of people living with HBV requiring antiviral therapy can be identified. Our findings suggest that clinical staging can be decentralised down to district hospital level in sub-Saharan Africa. European Association for the Study of the Liver Foundation, John C Martin Foundation. For the French translation of the abstract see Supplementary Materials section.

中文翻译：

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制定和评估简单治疗资格评分 (HEPSANET) 以分散非洲乙型肝炎护理：一项横断面研究

消除乙型肝炎病毒 (HBV) 需要扩大和分散乙型肝炎护理服务。然而，外围卫生机构缺乏诊断工具来评估抗病毒治疗的资格。通过非洲乙型肝炎合作网络 (HEPSANET)，我们的目标是使用较低级别机构普遍提供的测试来制定和评估评分，以简化乙肝病毒感染者抗病毒治疗资格的评估。我们调查了撒哈拉以南非洲不同医疗保健水平的临床和实验室参数的可用性。我们使用 HEPSANET 数据集（撒哈拉以南非洲地区未接受治疗的乙型肝炎病毒感染者的最大横截面数据集）的数据来得出并验证分数。如果来自该数据集的参与者年龄在 18 岁或以上，并且具有通过肝脏硬度测量或肝脏组织病理学确定的肝纤维化阶段，则他们将被纳入分析。患有合并感染或代谢紊乱的参与者被排除在外。我们按地理位置将参与者分配到推导和验证集。在推导集中，我们使用逐步逻辑回归来确定最佳执行参数，以识别符合 2017 年欧洲肝脏研究协会 (EASL) 标准的参与者。将回归系数转换为整数点，以构建针对不同医疗保健水平的简化算法。在验证集中，我们估计了用于识别 2017 年 EASL 标准定义的抗病毒治疗资格的简化算法的接收者操作特征、敏感性和特异性。在来自 8 个国家的 11 个地点进行的调查中，地区医院普遍提供了天冬氨酸转氨酶 (AST)、丙氨酸转氨酶 (ALT) 和血小板计数，而乙型肝炎 e 抗原和护理点 HBV DNA 检测仅提供地区、省级以上医院。在 HEPSANET 数据库的 2895 名参与者中（1740 名 [60·1%] 男性，1155 名 [39·9%] 女性），409 名 (14·1%) 符合 EASL 抗病毒治疗资格标准。在推导集中，最佳区级医院评分为：ALT（IU/L）、小于40（0分）、40~79（+1）、80或以上（+2）；AST (IU/L)，低于 40 (0)、40–79 (+1)、80 或更高 (+2)；血小板计数 (10/L)，小于 100 (+2)、100–149 (+1)、150 或以上 (0)。当结合不需要任何生物学测试的失代偿性肝硬化的家族史和临床数据时，2点或更多的截止点的敏感性和特异性分别为82%（95% CI 76-86）和95%（93- 96）以确定推导集中符合治疗资格的个体，以及验证集中分别为 78%（71-85）和 87%（86-89）的个体。使用结合血小板计数、AST 和 ALT 的评分，可以识别大多数需要抗病毒治疗的 HBV 感染者。我们的研究结果表明，临床分期可以下放到撒哈拉以南非洲地区的地区医院一级。欧洲肝脏研究协会基金会、约翰·C·马丁基金会。有关摘要的法文翻译，请参阅补充材料部分。