NS5A inhibitors are an important option for treating chronic HCV-GT4 patients. Retreatments after NS5A-based DAAs failure are limited. We aimed to determine the effectiveness and safety of SOF/VEL-containing regimens for HCV retreatment after NS5A-regimen failure. Prospective cohort study assessing the efficacy and safety of retreatment with SOF/VEL in addition to either voxilaprevir or ribavirin in patients who had failed previous NS5A-based DAA treatment. The primary outcome was SVR12. Safety and tolerability data were collected. One hundred fifty patients were included. The mean age was 53 years, 64% were male, and 50% of included patients had liver cirrhosis, with a mean FIB-4 score of 3.12 (± 2.30) and Child-Turcotte-Pugh (CTP) score of 7.27 (± 0.48), and failed previous SOF/DCV + RBV, they were assigned to 24 weeks of SOF/VEL + RBV. The remaining 50% of participants had no liver cirrhosis and failed previous SOF/DCV, they were assigned to 12 weeks of treatment with SOF/VEL/VOX. Overall, SVR12 was achieved by 96% (n = 144/150) of included patients; 97.33% for SOF/VEL/VOX and 94.67% for SOF/VEL/RBV. Thirty-one patients experienced mild AEs; the most commonly reported mild AE in the SOF/VEL + RBV group was hyperbilirubinemia (n = 9) whereas in the SOF/VEL/VOX group were headache (n = 4) and vertigo (n = 4). Only one patient in SOF/VEL + RBV reported moderate treatment-related AE in the form of anemia and no reported severe AE. Retreatment of non-cirrhotic patients with 12 weeks SOF/VEL/VOX and treatment of cirrhotic patients with 24 weeks with SOF/VEL + RBV after the failure of first-line NS5A-based therapy was an effective and well-tolerated treatment option.

中文翻译：

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含有 SOF/VEL 的救援疗法治疗先前基于 NS5A 抑制剂的 DAA 失败的慢性 HCV-GT4 患者的有效性和安全性

NS5A抑制剂是治疗慢性HCV-GT4患者的重要选择。基于 NS5A 的 DAA 失败后的再治疗是有限的。我们的目的是确定包含 SOF/VEL 的方案在 NS5A 方案失败后用于 HCV 再治疗的有效性和安全性。前瞻性队列研究评估了在先前基于 NS5A 的 DAA 治疗失败的患者中，除了伏西拉瑞韦或利巴韦林之外，再使用 SOF/VEL 进行治疗的有效性和安全性。主要结局是 SVR12。收集安全性和耐受性数据。其中包括一百五十名患者。平均年龄为 53 岁，64% 为男性，50% 的纳入患者患有肝硬化，平均 FIB-4 评分为 3.12 (± 2.30)，Child-Turcotte-Pugh (CTP) 评分为 7.27 (± 0.48) ），并且之前的 SOF/DCV + RBV 未通过，他们被分配到 24 周的 SOF/VEL + RBV。其余 50% 的参与者没有肝硬化，并且之前的 SOF/DCV 失败，他们被分配接受 12 周的 SOF/VEL/VOX 治疗。总体而言，96% (n = 144/150) 的纳入患者实现了 SVR12；SOF/VEL/VOX 为 97.33%，SOF/VEL/RBV 为 94.67%。31 名患者出现轻度 AE；SOF/VEL + RBV 组中最常见的轻度 AE 是高胆红素血症 (n = 9)，而 SOF/VEL/VOX 组中最常见的轻度 AE 是头痛 (n = 4) 和眩晕 (n = 4)。SOF/VEL + RBV 中只有一名患者报告了贫血形式的中度治疗相关 AE，没有报告严重 AE。在一线 NS5A 治疗失败后，对非肝硬化患者进行 12 周 SOF/VEL/VOX 重新治疗以及对肝硬化患者进行 24 周 SOF/VEL + RBV 治疗是一种有效且耐受性良好的治疗选择。