Medical Department, St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia.
Aklilu Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia.
BMC Med. 2018 Dec 17;16(1):234. doi: 10.1186/s12916-018-1229-x.
The World Health Organization has set an ambitious goal of eliminating viral hepatitis as a major public health threat by 2030. However, in sub-Saharan Africa, antiviral treatment of chronic hepatitis B (CHB) is virtually unavailable. Herein, we present the 1-year results of a pilot CHB treatment program in Ethiopia.
At a public hospital in Addis Ababa, CHB patients were treated with tenofovir disoproxil fumarate based on simplified eligibility criteria. Baseline assessment included liver function tests, viral markers, and transient elastography (Fibroscan). Changes in laboratory markers were analyzed using Wilcoxon signed-rank tests. Adherence to therapy was measured by pharmacy refill data.
Out of 1303 patients, 328 (25.2%) fulfilled the treatment criteria and 254 (19.5%) had started tenofovir disoproxil fumarate therapy prior to September 1, 2016. Of the patients who started therapy, 30 (11.8%) died within the first year of follow-up (28 of whom had decompensated cirrhosis), 9 (3.5%) self-stopped treatment, 7 (2.8%) were lost to follow-up, and 4 (1.6%) were transferred out. In patients who completed 12 months of treatment, the median Fibroscan value declined from 12.8 to 10.4 kPa (p < 0.001), 172 of 202 (85.1%) patients with available pharmacy refill data had taken ≥ 95% of their tablets, and 161 of 189 (85.2%) patients with viral load results had suppressed viremia. Virologic failure (≥ 69 IU/mL) at 12 months was associated with high baseline HBV viral load (> 1,000,000 IU/mL; adjusted OR 2.41; 95% CI 1.04-5.55) and suboptimal adherence (< 95%; adjusted OR 3.43, 95% CI 1.33-8.88).
This pilot program demonstrated that antiviral therapy of CHB can be realized in Ethiopia with good clinical and virologic response. Early mortality was high in patients with decompensated cirrhosis, underscoring the need for earlier detection of hepatitis B virus infection and timely initiation of treatment, prior to the development of irreversible complications, in sub-Saharan Africa.
NCT02344498 (ClinicalTrials.gov identifier). Registered 16 January 2015.
世界卫生组织设定了一个雄心勃勃的目标，即在 2030 年之前消除病毒性肝炎这一重大公共卫生威胁。然而，在撒哈拉以南非洲地区，慢性乙型肝炎（CHB）的抗病毒治疗几乎无法实现。在此，我们介绍了在埃塞俄比亚开展的一项 CHB 治疗试点项目的 1 年结果。
在亚的斯亚贝巴的一家公立医院，根据简化的纳入标准，使用替诺福韦酯富马酸对 CHB 患者进行治疗。基线评估包括肝功能检查、病毒标志物和瞬时弹性成像（Fibroscan）。采用 Wilcoxon 符号秩检验分析实验室标志物的变化。通过药房补药数据来衡量治疗的依从性。
在 1303 名患者中，有 328 名（25.2%）符合治疗标准，有 254 名（19.5%）在 2016 年 9 月 1 日之前开始使用替诺福韦酯富马酸治疗。在开始治疗的患者中，有 30 名（11.8%）在随访的第 1 年内死亡（其中 28 名患有失代偿性肝硬化），有 9 名（3.5%）自行停药，有 7 名（2.8%）失访，有 4 名（1.6%）转院。在完成 12 个月治疗的患者中，中位数 Fibroscan 值从 12.8kPa 降至 10.4kPa（p<0.001），202 名中有 172 名（85.1%）可提供药房补药数据的患者服用了≥95%的药物，189 名中有 161 名（85.2%）病毒载量结果可用的患者病毒血症得到抑制。12 个月时病毒学失败（≥69IU/mL）与基线 HBV 病毒载量高（>1,000,000IU/mL；调整后的比值比 2.41；95%置信区间 1.04-5.55）和治疗依从性不佳（<95%；调整后的比值比 3.43，95%置信区间 1.33-8.88）相关。
该试点项目表明，在埃塞俄比亚，CHB 的抗病毒治疗可以取得良好的临床和病毒学反应。失代偿性肝硬化患者的早期死亡率较高，这突出表明，在撒哈拉以南非洲地区，需要更早地发现乙型肝炎病毒感染，并在不可逆并发症发生之前及时开始治疗。
NCT02344498（ClinicalTrials.gov 标识符）。2015 年 1 月 16 日注册。
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