Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, Korea.
Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Korean J Intern Med. 2019 Jul;34(4):794-801. doi: 10.3904/kjim.2017.368. Epub 2018 May 25.
BACKGROUND/AIMS: Previous studies have reported a high rate of sustained virologic response (SVR) and a low rate of serious adverse events with the use of daclatasvir (DCV) and asunaprevir (ASV) combination therapy. We evaluated the efficacy and safety of DCV and ASV combination therapy for patients with chronic hepatitis C virus (HCV) genotype 1b infection in real world.
We enrolled 278 patients (184 treatment-naïve patients) from five hospitals in Daegu and Gyeongsangbuk-do. We evaluated the rates of rapid virologic response (RVR), end-of-treatment response (ETR), and SVR at 12 weeks after completion of treatment (SVR12). Furthermore, we investigated the rate of adverse events and predictive factors of SVR12 failure.
The mean age of patients was 59.5 ± 10.6 years, and 140 patients (50.2%) were men. Seventy-seven patients had cirrhosis. Baseline information regarding nonstructural protein 5A (NS5A) sequences was available in 268 patients. Six patients presented with pretreatment NS5A resistance-associated variants. The RVR and the ETR rates were 96.6% (258/267) and 95.2% (223/232), respectively. The overall SVR12 rate was 91.6% (197/215). Adverse events occurred in 17 patients (7.9%). Six patients discontinued treatment because of liver enzyme elevation (n = 4) and severe nausea (n = 2). Among these, four achieved SVR12. Other adverse events observed were fatigue, headache, diarrhea, dizziness, loss of appetite, skin rash, and dyspnea. Univariate analysis did not show significant predictive factors of SVR12 failure.
DCV and ASV combination therapy showed high rates of RVR, ETR, and SVR12 in chronic HCV genotype 1b-infected patients in real world and was well tolerated without serious adverse events.
背景/目的：先前的研究报告称，使用达拉他韦（DCV）和asunaprevir（ASV）联合疗法治疗慢性丙型肝炎病毒（HCV）基因型 1b 感染患者，持续病毒学应答（SVR）率高，严重不良事件发生率低。我们在真实世界中评估了 DCV 和 ASV 联合疗法治疗慢性 HCV 基因型 1b 感染患者的疗效和安全性。
我们从大邱和庆尚北道的五家医院招募了 278 名患者（184 名初治患者）。我们评估了治疗结束时的快速病毒学应答（RVR）、治疗结束应答（ETR）和治疗后 12 周的 SVR12 率。此外，我们还研究了不良事件的发生率和 SVR12 失败的预测因素。
患者的平均年龄为 59.5 ± 10.6 岁，140 名患者（50.2%）为男性。77 名患者患有肝硬化。268 名患者的非结构蛋白 5A（NS5A）序列的基线信息可用。6 名患者在治疗前存在 NS5A 耐药相关变异。RVR 和 ETR 率分别为 96.6%（258/267）和 95.2%（223/232）。总的 SVR12 率为 91.6%（197/215）。17 名患者（7.9%）发生不良事件。6 名患者因肝酶升高（n=4）和严重恶心（n=2）而停止治疗。其中，4 名患者达到了 SVR12。观察到的其他不良事件包括疲劳、头痛、腹泻、头晕、食欲不振、皮疹和呼吸困难。单因素分析未显示 SVR12 失败的显著预测因素。
DCV 和 ASV 联合疗法在真实世界中显示出高 RVR、ETR 和 SVR12 率，且耐受性良好，无严重不良事件。
