Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Faculty of Internal Medicine, School of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan.
Kaohsiung J Med Sci. 2021 Apr;37(4):334-345. doi: 10.1002/kjm2.12315. Epub 2020 Nov 5.
Chronic hepatitis C (CHC) is a major cause of cirrhosis, hepatocellular carcinoma (HCC), and mortality. Eliminating hepatitis C virus (HCV) can greatly improve long-term outcomes. Several direct-acting antiviral agents (DAAs), including sofosbuvir (SOF) plus different NS5A inhibitors, as well as non-SOF-based DAAs, including glecaprevir/pibrentasvir (GLE/PIB), have been approved for treating CHC genotype-2 (GT-2) patients in Taiwan. However, there is limited real-world effectiveness data regarding these different regimens. Thus, we aimed to evaluate the real-world efficacy in CHC GT-2 patients who underwent these DAA regimens. We retrospectively enrolled CHC GT-2 patients who were treated with SOF-based DAAs or GLE/PIB at a single medical center. A total of 704 enrolled patients were treated with either SOF + ribavirin (RBV), SOF/daclatasvir (DCV) ± RBV, SOF/ledipasvir (LDV) ± RBV, SOF/velpatasvir (VEL) ± RBV, or with GLE/PIB. The overall sustained virological response (SVR) rate was 97.9%. The SVR rate was significantly lower in the SOF + RBV group (95.6%) than in the non-SOF + RBV (98.9%) group, especially compared to the SOF/DCV (100%) and GLE/PIB groups (99.5%). Among patients treated with SOF + RBV, cirrhotic patients had significantly lower SVR rates than noncirrhotic patients (89.4% vs 98.2%). Multivariate analysis showed that patients with a younger age, hepatitis B virus coinfection, baseline cirrhosis, or those who received SOF + RBV were less likely to achieve SVR. In conclusion, for CHC GT-2 patients, SOF in combination with DCV, LDV, or VEL, as well as GLE/PIB, achieved similar high efficacies, regardless of cirrhosis, treatment experience, or chronic kidney disease status. Therefore, the use of DAA therapy to eradicate HCV should not be delayed in these populations.
慢性丙型肝炎(CHC)是肝硬化、肝细胞癌(HCC)和死亡率的主要原因。消除丙型肝炎病毒(HCV)可以大大改善长期预后。几种直接作用抗病毒药物(DAA),包括索非布韦(SOF)加不同的 NS5A 抑制剂,以及非 SOF 基础的 DAA,包括格卡瑞韦/哌仑他韦(GLE/PIB),已在台湾获得批准用于治疗 CHC 基因型 2(GT-2)患者。然而,对于这些不同方案的真实世界疗效数据有限。因此,我们旨在评估接受这些 DAA 方案治疗的 CHC GT-2 患者的真实世界疗效。我们回顾性纳入在一家医疗中心接受 SOF 基础 DAA 或 GLE/PIB 治疗的 CHC GT-2 患者。共有 704 名入组患者接受 SOF+利巴韦林(RBV)、SOF/达卡他韦(DCV)±RBV、SOF/雷迪帕韦(LDV)±RBV、SOF/伏西瑞韦(VEL)±RBV 或 GLE/PIB 治疗。总的持续病毒学应答(SVR)率为 97.9%。SOF+RBV 组(95.6%)的 SVR 率明显低于非 SOF+RBV 组(98.9%),尤其是 SOF/DCV(100%)和 GLE/PIB 组(99.5%)。在接受 SOF+RBV 治疗的患者中,肝硬化患者的 SVR 率明显低于非肝硬化患者(89.4% vs 98.2%)。多变量分析显示,年龄较小、乙型肝炎病毒合并感染、基线肝硬化或接受 SOF+RBV 治疗的患者更不可能达到 SVR。总之,对于 CHC GT-2 患者,SOF 联合 DCV、LDV 或 VEL 以及 GLE/PIB 均具有相似的高疗效,无论是否存在肝硬化、治疗经验或慢性肾脏病状态。因此,在这些人群中不应延迟使用 DAA 治疗来根除 HCV。