Faculty of Medicine, Cairo University, Cairo, Egypt.
Faculty of Medicine, Helwan University, Cairo, Egypt.
Aliment Pharmacol Ther. 2018 Feb;47(3):421-431. doi: 10.1111/apt.14428. Epub 2017 Nov 29.
Treatment of chronic hepatitis C using combination of sofosbuvir (SOF) and daclatasvir (DCV) was used in several clinical trials and multicentre studies, which were somewhat limited to genotypes 1-3. The national program in Egypt is using SOF-DCV combination for large scale treatment.
To assess the efficacy and safety of combined SOF-DCV in treating patients with HCV-G4 in a real-world setting.
Data and outcome of chronic HCV patients who were treated for 12 weeks with generic medications: DCV 60 mg plus SOF 400 mg ± ribavirin (RBV) within the national hepatitis C treatment program in Egypt are presented. Treatment-naïve patients without cirrhosis were treated without RBV, and those who had cirrhosis or were treatment-experienced (interferon experienced or SOF experienced) received RBV. Efficacy and safety were assessed, and baseline factors associated with sustained virological response at post-treatment week 12 (SVR12) were explored.
During the first 2 months of the programme, 18 378 patients with HCV-G4 started treatment with SOF-DCV with or without RBV. Overall, 95.1% achieved SVR12 (95.4% among patients treated without RBV and 94.7% for patients treated with RBV, P = .32). Treatment was prematurely discontinued in only 1.5% of patients. The most common events leading to discontinuation were patient withdrawal (n = 76) and pregnancy (n = 5). Five deaths occurred within this group.
Real-world experience of generic SOF-DCV in patients with chronic HCV-G4 proved to be safe and associated with a high SVR12 rate, in patients with different stages of fibrosis.
索磷布韦（SOF）和达卡他韦（DCV）联合治疗慢性丙型肝炎已在多项临床试验和多中心研究中使用，这些研究在一定程度上仅限于基因型 1-3。埃及的国家计划正在大规模使用 SOF-DCV 联合治疗。
评估 SOF-DCV 联合治疗在真实世界环境中治疗 HCV-G4 患者的疗效和安全性。
报告了在埃及国家丙型肝炎治疗计划中，使用通用药物（DCV 60mg 加 SOF 400mg±利巴韦林[RBV]）治疗 12 周的慢性丙型肝炎患者的数据和结局。无肝硬化的初治患者未接受 RBV 治疗，而有肝硬化或治疗经验（干扰素经验或 SOF 经验）的患者接受 RBV 治疗。评估了疗效和安全性，并探讨了与治疗后 12 周持续病毒学应答（SVR12）相关的基线因素。
在该计划的头 2 个月内，18378 例 HCV-G4 患者开始接受 SOF-DCV 联合或不联合 RBV 治疗。总体而言，95.1%的患者达到 SVR12（未接受 RBV 治疗的患者中为 95.4%，接受 RBV 治疗的患者中为 94.7%，P=.32）。仅有 1.5%的患者提前停药。导致停药的最常见事件是患者撤回（n=76）和怀孕（n=5）。该组中有 5 例死亡。
在不同纤维化阶段的慢性 HCV-G4 患者中，真实世界中使用通用 SOF-DCV 的经验证明是安全的，且 SVR12 率高。
