Cairo University, Faculty of Medicine, Endemic Medicine and Hepato-Gastroenterology Department, Cairo, Egypt.
National Medical Institute of Damanhour, Damanhour, Egypt.
Rev Inst Med Trop Sao Paulo. 2022 Sep 5;64:e50. doi: 10.1590/S1678-9946202264050. eCollection 2022.
Despite the high sustained virologic response (SVR) rates of direct-acting antiviral (DAAs) therapy, a small number of patients does not eradicate the virus, and these patients represent a challenge. This study aims to compare the outcomes of three second-line regimens for DAAs-experienced patients with chronic hepatitis C (CHC). This prospective observational study was conducted at the Damanhur Viral Hepatitis Center from January 2017 to February 2020. We included patients with CHC who did not achieve SVR after the complete course of Sofosbuvir/Daclatasvir±Ribavirin (SOF/DAC±RBV). The primary endpoint was SVR-12 after re-treatment. This study included 360 patients (with a mean age of 51.53±11.38 years). Approximately 51.1% of the patients were males, and 65.5% had liver cirrhosis. All patients of group 1 (45 patients) received SOF/VEL/VOX over 12-weeks; SVR-12 was achieved in 44 patients (97.8%). Group 2 (28 patients) received SOF/DAC/RBV over 24-weeks; (one patient was lost during follow-ups and one patient discontinued treatment due to hepatic decompensation). SVR-12 was achieved in 25 patients (96.2%). Group 3 (287 patients) received SOF/Ombitasvir/Paritaprevir/Ritonavir/RBV) over 12-weeks. Eight patients were lost during follow-ups, and one patient discontinued treatment due to grade 4 adverse events. SVR-12 was achieved in 276 patients (99.3%). There was no difference between the groups regarding their age, gender distribution, baseline viral load or comorbidities. Adverse events (thrombocytopenia, anemia, hyperbilirubinaemia and prolonged INR) were significantly higher in group 3, while group 1 did not experience any. The three studied retreatment regimens can be used for DAAs treatment-experienced patients considering availability. The SOF/VEL/VOX combination had the least adverse events.
尽管直接作用抗病毒（DAA）治疗的持续病毒学应答（SVR）率很高，但仍有一小部分患者无法清除病毒，这些患者构成了挑战。本研究旨在比较三种二线方案治疗 DAA 治疗后慢性丙型肝炎（CHC）患者的结局。这是一项前瞻性观察性研究，于 2017 年 1 月至 2020 年 2 月在达曼胡尔病毒肝炎中心进行。我们纳入了 Sofosbuvir/Daclatasvir±Ribavirin（SOF/DAC±RBV）全程治疗后未达到 SVR 的 CHC 患者。主要终点是再治疗后的 SVR-12。本研究纳入了 360 例患者（平均年龄 51.53±11.38 岁）。约 51.1%的患者为男性，65.5%有肝硬化。第 1 组（45 例）的所有患者接受 SOF/VEL/VOX 治疗 12 周；44 例（97.8%）达到 SVR-12。第 2 组（28 例）接受 SOF/DAC/RBV 治疗 24 周；（1 例在随访期间丢失，1 例因肝功能失代偿而停止治疗）。25 例（96.2%）达到 SVR-12。第 3 组（287 例）接受 SOF/Ombitasvir/Paritaprevir/Ritonavir/RBV）治疗 12 周。8 例在随访期间丢失，1 例因 4 级不良事件而停止治疗。276 例（99.3%）达到 SVR-12。各组之间的年龄、性别分布、基线病毒载量或合并症无差异。不良事件（血小板减少、贫血、高胆红素血症和 INR 延长）在第 3 组显著更高，而第 1 组无不良事件。考虑到可用性，三种研究的再治疗方案均可用于 DAA 治疗后患者。SOF/VEL/VOX 联合治疗的不良事件最少。
