Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
J Formos Med Assoc. 2019 May;118(5):907-913. doi: 10.1016/j.jfma.2018.09.016. Epub 2018 Oct 11.
Sofosbuvir (SOF) and daclatasvir (DCV) treatment achieves excellent efficacy and safety in treating chronic hepatitis C (CHC) with various genotypes. Real world experience of SOF/DCV regimen to treat genotype 2 CHC was scanty in Asia. This study aimed to evaluate the effectiveness and safety of SOF/DCV with or without ribavirin to treat genotype 2 CHC patients in real world practice in Taiwan.
Patients with genotype 2 CHC treated with 12-week of SOF/DCV or SOF/DCV/ribavirin were enrolled prospectively. Effectiveness was evaluated by sustained virological response (SVR) which was defined as undetectable hepatitis C virus (HCV) RNA at post-treatment week 12. Adverse events were recorded for safety analysis.
In total of 32 patients were enrolled from October 2016 to June 2017. All were infected with genotype 2 HCV. Sixteen patients (50%) exhibited cirrhosis including 6 patients with decompensation. Regimens of SOF/DCV and SOF/DCV/ribavirin were used to treat 14 and 18 patients, respectively. SVR was achieved in all 31 patients (100%) who completed follow-up. Significantly higher levels of cholesterol (p = 0.013) and higher low density lipoprotein-cholesterol (p = 0.015) were exhibited after successful viral clearance. SOF/DCV/ribavirin regimen resulted in more adverse events, significantly higher bilirubin levels, and decline of hemoglobin during treatment than SOF/DCV regimen. Four patients with chronic kidney disease maintained renal function during treatment. Overall, SOF/DCV or SOF/DCV/ribavirin treatment was well tolerated.
SOF/DCV with or without ribavirin is highly effective and safe for patients with genotype 2 HCV infection in real-world experience in Taiwan.
索非布韦（SOF）和达卡他韦（DCV）治疗方案对各种基因型的慢性丙型肝炎（CHC）具有出色的疗效和安全性。亚洲地区关于 SOF/DCV 方案治疗 2 型 CHC 的真实世界经验较少。本研究旨在评估 SOF/DCV 联合或不联合利巴韦林治疗台湾地区真实世界中 2 型 CHC 患者的有效性和安全性。
前瞻性纳入接受 12 周 SOF/DCV 或 SOF/DCV/利巴韦林治疗的 2 型 CHC 患者。通过治疗后 12 周时的持续病毒学应答（SVR）评估疗效，SVR 定义为检测不到 HCV RNA。记录不良反应以进行安全性分析。
共纳入 2016 年 10 月至 2017 年 6 月期间的 32 例患者。所有患者均感染 2 型 HCV，其中 16 例（50%）患者存在肝硬化，包括 6 例失代偿期肝硬化。SOF/DCV 和 SOF/DCV/利巴韦林方案分别用于治疗 14 例和 18 例患者。所有完成随访的 31 例患者（100%）均达到 SVR。成功清除病毒后，患者的胆固醇（p=0.013）和低密度脂蛋白胆固醇（p=0.015）水平显著升高。SOF/DCV/利巴韦林方案的不良反应发生率更高，治疗期间胆红素水平更高，血红蛋白水平下降，与 SOF/DCV 方案相比差异具有统计学意义。4 例慢性肾脏病患者在治疗期间肾功能保持稳定。总体而言，SOF/DCV 或 SOF/DCV/利巴韦林治疗方案在台湾的真实世界经验中具有良好的耐受性。
SOF/DCV 联合或不联合利巴韦林治疗方案对台湾地区 2 型 HCV 感染患者具有高效且安全的效果。
