Endemic Medicine and Hepatogastroentrology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
Tropical Medicine Department, National Hepatology & Tropical Medicine Research Institute, Cairo, Egypt.
Aliment Pharmacol Ther. 2017 Mar;45(5):681-687. doi: 10.1111/apt.13923. Epub 2017 Jan 9.
Chronic hepatitis C virus infection is one of the most important health problems in Egypt. The Ministry of Health's National Treatment Programme introduced sofosbuvir-based therapy in October 2014.
To assess the clinical effectiveness and predictors of response to SOF-based treatment regimens, either dual therapy, with SOF/ribavirin (RBV) for 6 months or triple therapy with SOF/peg-IFN-alfa-2a/RBV for 3 months, in a cohort of patients treated in National Treatment Programme affiliated centres in Egypt.
Between October 2014 and end of 2014, patients who were eligible for treatment were classified according to their eligibility for interferon therapy: Group 1 (interferon eligible) were treated with triple therapy for 12 weeks and Group 2 (interferon ineligible) were treated with dual therapy for 24 weeks. Difficult to treat patients included those with F3-F4 on Metavir score, Fib-4 >3.25, albumin ≤3.5, total Bilirubin >1.2 mg/dL, INR >1.2 and platelet count <150 000 mm .
Twelve weeks post-treatment data were available on 14 409 patients; 8742 in group 1 and 5667 in group 2. In group 1, the sustained virological response at week 12 (SVR12) was 94% and in group 2 the SVR12 was 78.7%. Multivariate logistic regression analysis in which treatment failure is the dependent variable was done. Male gender, being a difficult to treat patient and previous interferon therapy were significant predictors of nonresponse in both treatment groups.
Results of sofosbuvir-based therapies in Egypt achieved similar rates of SVR12 as seen in phase III efficacy studies.
慢性丙型肝炎病毒感染是埃及最重要的健康问题之一。卫生部的国家治疗计划于 2014 年 10 月推出了基于索非布韦的治疗方法。
评估在埃及国家治疗计划附属中心接受治疗的患者中，基于索非布韦的治疗方案（双药治疗，索非布韦/利巴韦林[RBV]治疗 6 个月或三药治疗，索非布韦/聚乙二醇干扰素-α-2a/RBV 治疗 3 个月）的临床疗效和反应预测因素。
2014 年 10 月至 2014 年底，根据其是否适合干扰素治疗对符合条件的患者进行分类：第 1 组（适合干扰素）接受三联治疗 12 周，第 2 组（不适合干扰素）接受双药治疗 24 周。难治疗患者包括 Metavir 评分 F3-F4、Fib-4>3.25、白蛋白≤3.5、总胆红素>1.2mg/dL、INR>1.2 和血小板计数<150000mm。
14409 例患者中有 12 周治疗后的数据；第 1 组 8742 例，第 2 组 5667 例。第 1 组中，第 12 周持续病毒学应答（SVR12）为 94%，第 2 组为 78.7%。对以治疗失败为因变量的多变量逻辑回归分析进行了分析。在两组中，男性、为难治患者和以前的干扰素治疗都是无反应的显著预测因素。
埃及基于索非布韦的治疗结果与 III 期疗效研究中观察到的 SVR12 相似。
