Endemic Medicine and Hepatogastroentrology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
Endemic Medicine and Hepatogastroentrology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
J Hepatol. 2018 Apr;68(4):691-698. doi: 10.1016/j.jhep.2017.11.034. Epub 2017 Dec 6.
The introduction of direct-acting antivirals for hepatitis C virus (HCV) in Egypt led to massive treatment uptake, with Egypt's national HCV treatment program becoming the largest in the world. The aim of this paper is to present the Egyptian experience in planning and prioritizing mass treatment for patients with HCV, highlighting the difficulties and limitations of the program, as a guide for other countries of similarly limited resources.
Baseline data of 337,042 patients, treated between October 2014 to March 2016 in specialized viral hepatitis treatment centers, were grouped into three equal time intervals of six months each. Patients were treated with different combinations of direct-acting antivirals, with or without ribavirin and pegylated interferon. Baseline data, percentage of patients with known outcome, and sustained virological response at week 12 (SVR12) were analyzed for the three cohorts. The outcomes of 94,258 patients treated in the subsequent two months are also included.
For cohort-1, treatment was prioritized for patients with advanced fibrosis (F3-F4 fibrosis, liver stiffness ≥9.5 kPa, or Fibrosis-4 ≥3.25). Starting cohort-2, all stages of fibrosis were included (F0-F4). The prioritization strategy in the initial phase caused delays in enrollment and massive backlogs. Cohort-1 patients were significantly older, and more had advanced fibrosis compared to subsequent cohorts. The percentage of patients with known SVR12 results were low initially, and increased with each cohort, as several methods to capture patient results were adopted. Sofosbuvir-ribavirin therapy for 24 weeks had the lowest SVR12 rate (82.7%); while other therapies were associated with SVR12 rates between 94% and 98%.
Prioritization based on fibrosis stage was not effective and enrollment increased greatly only after including all stages of fibrosis. The availability of generic drugs reduced costs, and helped massively increase uptake of the program. Post-treatment follow-up was initially very low, and although this has increased, further improvement is still needed.
We are presenting the largest national program for HCV treatment in the world. We clearly demonstrate that hepatitis C can be cured efficiently in large scale real-life programs. This is a clear statement that global HCV eradication is foreseeable, providing a model for other countries with limited resources and prevalent HCV. Moreover, the availability of generic products has influenced the success of this program.
在埃及引入直接作用抗病毒药物治疗丙型肝炎病毒（HCV）导致大量患者接受治疗，埃及国家 HCV 治疗计划成为全球规模最大的治疗计划。本文旨在介绍埃及在规划和优先治疗 HCV 患者方面的经验，重点介绍该计划的困难和局限性，为资源同样有限的其他国家提供参考。
对 2014 年 10 月至 2016 年 3 月在专门的病毒性肝炎治疗中心接受治疗的 337042 名患者的基线数据进行分组，每组 6 个月，共 3 组。患者接受不同组合的直接作用抗病毒药物治疗，包括利巴韦林和聚乙二醇干扰素。对三组患者的基线数据、已知结局患者的比例和第 12 周持续病毒学应答（SVR12）进行分析。还包括随后两个月内治疗的 94258 名患者的结局。
对于第 1 组，治疗优先考虑纤维化程度较高的患者（F3-F4 纤维化、肝硬度值≥9.5kPa 或 Fibrosis-4≥3.25）。从第 2 组开始，所有纤维化阶段都包括在内（F0-F4）。在初始阶段的优先排序策略导致了入组延迟和大量积压。第 1 组患者年龄明显较大，且与后续组相比，有更多的患者纤维化程度较高。最初，已知 SVR12 结果的患者比例较低，随着采用了几种获取患者结果的方法，该比例逐渐增加。24 周的索非布韦联合利巴韦林治疗的 SVR12 率最低（82.7%）；而其他治疗方案的 SVR12 率在 94%至 98%之间。
基于纤维化阶段的优先排序并不有效，仅在包括所有纤维化阶段后，入组人数才大幅增加。仿制药的供应降低了成本，并帮助大幅增加了该计划的接受度。治疗后的随访最初非常低，尽管有所增加，但仍需要进一步改进。
我们正在介绍全球最大的 HCV 治疗国家计划。我们清楚地表明，丙型肝炎可以在大规模的现实生活项目中有效地治愈。这清楚地表明，全球丙型肝炎的消除是可以预见的，为资源有限和丙型肝炎流行的其他国家提供了一个模式。此外，仿制药的供应影响了该计划的成功。
