Infectious and Tropical Diseases Department, Viet Tiep Hospital, Hai Phong, Vietnam.
Unité d'Epidémiologie des Maladies Emergentes, Institut Pasteur, Paris, France.
Clin Infect Dis. 2021 Sep 7;73(5):e1072-e1077. doi: 10.1093/cid/ciaa1814.
Treatment eligibility and the accuracy of its simplified criteria have been poorly documented in patients with chronic hepatitis B virus (HBV) infection worldwide, especially in low- and middle-income countries.
From a cohort of HBV-infected patients in Vietnam, we assessed the proportion of patients eligible for treatment using the national guidelines based on reference tests (HBV DNA quantification and FibroScan); and the accuracy of simplified treatment criteria free from HBV DNA and FibroScan (Treatment Eligibility in Africa for the Hepatitis B Virus [TREAT-B] score and simplified World Health Organization [WHO] criteria) to select patients for antiviral therapy using the national guidelines as a reference.
We analyzed 400 consecutive treatment-naïve HBV-monoinfected patients: 49% males, median age 38 years (range, 18-86), 32% hepatitis B e antigen-positive, median HBV DNA 4.8 log10 IU/mL (undetectable -8.4), median FibroScan 5.3 kPa (3.0-67.8), and 25% having significant liver fibrosis including 12% with cirrhosis. Of these, 167 (42%) fulfilled treatment criteria according to national guidelines. Using the national criteria as a reference, the performance of TREAT-B to select patients for treatment was high (area under the receiver operating characteristic [AUROC], 0.89 [95% confidence interval 0.87-0.92]) with a sensitivity of 74.3% and a specificity of 88.4%. In a subset of patients with 2 alanine aminotransferase measurements over a 6-month period (n = 89), the AUROC of TREAT-B was significantly higher than that of the simplified WHO criteria (P < .001).
Our study suggests that a large proportion of patients with chronic HBV infection require antiviral therapy in Vietnam. Compared with the simplified WHO criteria free from HBV DNA quantification, TREAT-B is a better alternative to easily indicate treatment eligibility and might help scale up treatment intervention in Vietnam.
在全球范围内，特别是在低收入和中等收入国家，慢性乙型肝炎病毒（HBV）感染者的治疗适应证及其简化标准的准确性记录较差。
我们从越南的乙型肝炎病毒感染者队列中评估了使用国家指南（基于参考检测，即 HBV DNA 定量和 FibroScan）确定的符合治疗条件的患者比例；以及不依赖 HBV DNA 和 FibroScan 的简化治疗标准（乙型肝炎病毒治疗在非洲的适用性评分[TREAT-B]和简化世界卫生组织[WHO]标准）的准确性，以便使用国家指南作为参考选择适合抗病毒治疗的患者。
我们分析了 400 例连续的初治 HBV 单感染患者：49%为男性，中位年龄为 38 岁（范围为 18-86 岁），32%乙型肝炎 e 抗原阳性，HBV DNA 中位值为 4.8 log10 IU/ml（检测不到-8.4），FibroScan 中位值为 5.3 kPa（3.0-67.8），25%存在显著的肝纤维化，包括 12%为肝硬化。其中，根据国家指南，167 例（42%）符合治疗标准。使用国家指南作为参考，TREAT-B 选择患者进行治疗的性能较高（接受者操作特征曲线下面积[AUROC]，0.89[95%置信区间 0.87-0.92]），敏感性为 74.3%，特异性为 88.4%。在接受 6 个月内 2 次丙氨酸氨基转移酶测量的患者亚组（n=89）中，TREAT-B 的 AUROC 明显高于简化 WHO 标准（P<.001）。
我们的研究表明，越南有很大比例的慢性乙型肝炎病毒感染者需要抗病毒治疗。与不依赖 HBV DNA 定量的简化 WHO 标准相比，TREAT-B 是一种更好的替代方法，可轻松指示治疗适应证，并有助于在越南扩大治疗干预措施。
