Department of Internal Medicine, Pusan National University School of Medicine, Busan, Korea.
Medical Research Institute, Pusan National University Hospital, Busan, Korea.
Korean J Intern Med. 2021 May;36(3):544-556. doi: 10.3904/kjim.2018.329. Epub 2019 Mar 19.
BACKGROUND/AIMS: Real-world, clinical practice data are lacking about sofosbuvir/ ribavirin (SOF/RBV) treatment of Korean patients with hepatitis C virus genotype 2 (HCV GT2) infection. This study investigated the efficacy and safety of SOF/RBV in Korean patients with HCV GT2 infection and clinical factors predicting sustained virological response 12 weeks (SVR12) after the end of SOF/RBV treatment.
A total of 181 patients with HCV GT2 with/without cirrhosis were treated with SOF/RBV for 16/12 weeks. Rapid virological response (RVR) was defined as non-detectable HCV RNA at 4 weeks.
The RVR rate was 80.7% (146/181), the end of treatment response rate was 97.8% (177/181) and the SVR12 rate was 92.8% (168/181). Of eight patients with relapse, four did not achieve RVR. Three patients had a history of hepatocellular carcinoma (HCC). Multivariable analysis showed that RVR (p = 0.015) and no previous history of HCC (p = 0.007) were associated with SVR12. Factors significantly contributing to RVR included cirrhosis, creatinine concentration, and pre-treatment HCV RNA level. SVR12 rate was significantly higher in RVR (+) than RVR (-) patients (95.2% vs. 82.9%, p = 0.011) and also significantly higher in patients without than with a history of HCC (94.1% vs. 72.7%, p = 0.008). During treatment, 80/181 patients (44.2%) experienced mild to moderate adverse events, with 32 (17.7%) requiring RBV dose reductions due to anemia.
SOF/RBV treatment was effective and tolerable in HCV GT2 patients. RVR and no previous history of HCC were positive predictors of SVR12.
背景/目的：关于索磷布韦/利巴韦林（SOF/RBV）治疗韩国丙型肝炎病毒基因型 2（HCV GT2）感染患者的真实临床实践数据尚缺乏。本研究旨在探讨 SOF/RBV 治疗韩国 HCV GT2 感染患者的疗效和安全性，以及治疗结束后 12 周持续病毒学应答（SVR12）的预测因素。
共纳入 181 例 HCV GT2 感染伴或不伴肝硬化的患者，接受 SOF/RBV 治疗 16/12 周。快速病毒学应答（RVR）定义为治疗 4 周时 HCV RNA 不可检测。
RVR 率为 80.7%（146/181），治疗结束时的应答率为 97.8%（177/181），SVR12 率为 92.8%（168/181）。8 例复发患者中，4 例未达到 RVR。3 例患者有肝细胞癌（HCC）病史。多变量分析显示，RVR（p=0.015）和无 HCC 既往史（p=0.007）与 SVR12 相关。显著影响 RVR 的因素包括肝硬化、肌酐浓度和治疗前 HCV RNA 水平。RVR（+）患者的 SVR12 率显著高于 RVR（-）患者（95.2% vs. 82.9%，p=0.011），无 HCC 既往史的患者的 SVR12 率也显著高于有 HCC 既往史的患者（94.1% vs. 72.7%，p=0.008）。治疗期间，181 例患者中有 80 例（44.2%）出现轻度至中度不良反应，32 例（17.7%）因贫血需要减少 RBV 剂量。
SOF/RBV 治疗 HCV GT2 患者有效且耐受良好。RVR 和无 HCC 既往史是 SVR12 的阳性预测因素。
