Sofosbuvir-based therapy for patients with chronic hepatitis C: Early experience of its efficacy and safety in Korea.
Sofosbuvir-based therapy for patients with chronic hepatitis C: Early experience of its efficacy and safety in Korea.
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DOI：
10.3350/cmh.2015.21.4.358
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发表时间：
2015-12
影响因子：
8.9
通讯作者：
Kim YJ
中科院分区：
文献类型：
--
作者：
Cho Y;Cho EJ;Lee JH;Yu SJ;Yoon JH;Kim YJ
以前的标准治疗慢性丙型肝炎（CHC）患者，包括聚乙二醇干扰素（IFN）和利巴韦林的组合，与次优疗效和严重的不良反应。一个直接作用的抗病毒药物的新时代正在韩国出现。本文报道了韩国CHC患者应用索非布韦为基础的治疗的早期经验。收集了索非布韦联合利巴韦林或索非布韦/雷迪帕韦联合或不联合利巴韦林治疗的CHC患者的疗效和安全性数据。这项回顾性研究纳入了2014年5月至2015年4月在首尔国立大学医院接受基于索非布韦治疗的25例连续患者（19例基因型1b，6例基因型2）。在第4周时，分别有85.7%和80%的基因型1b和2的患者达到了病毒学应答。与基因型1b的初治患者相比，干扰素治疗后HCV-RNA水平下降更慢。然而，这些患者在第12周的持续病毒学应答（SVR 12）率没有差异，高达100%。在HCV基因型1b的患者中，肝硬化的存在显著增加了第4周病毒学应答失败的风险（OR，11.0; P=0.011）。只有5名患者（20%）发生了轻微的不良事件，包括1级疲劳和头痛。血红蛋白水平略有下降后，索非布韦为基础的治疗，但没有提前停止这种治疗的情况。在真实的临床实践中，韩国CHC患者的索非布韦治疗达到了最佳的抗病毒疗效，不良事件不明显。长期随访数据是必要的，以确保持续的抗病毒疗效和长期安全的索非布韦为基础的无干扰素治疗。
The previous standard treatment for chronic hepatitis C (CHC) patients, comprising a combination of pegylated interferon (IFN) and ribavirin, was associated with suboptimal efficacy and severe adverse reactions. A new era of direct-acting antivirals is now dawning in Korea. Early experience of applying sofosbuvir-based therapy to CHC patients in Korea is reported herein. Data on efficacy and safety were collected for CHC patients treated with a combination of sofosbuvir plus ribavirin or sofosbuvir/ledipasvir with or without ribavirin. This retrospective study included 25 consecutive patients who received sofosbuvir-based therapy (19 with genotype 1b and 6 with genotype 2) at Seoul National University Hospital from May 2014 to April 2015. A virologic response was achieved at week 4 by 85.7% and 80% of the patients with genotypes 1b and 2, respectively. The HCV-RNA level decreased more slowly in IFN-experienced than in treatment-naïve patients with genotype 1b. However, the sustained virologic response at week 12 (SVR12) rate did not differ among these patients, and was as high as 100%. The presence of cirrhosis significantly increased the risk of a virologic response failure at week 4 (OR, 11.0; P=0.011) among patients with HCV genotype 1b. Only five patients (20%) experienced minor adverse events, including grade 1 fatigue and headache. The hemoglobin level decreased slightly after sofosbuvir-based therapy, but there was no case of premature discontinuation of this therapy. In a real clinical practice, sofosbuvir-based therapy for CHC patients in Korea achieved optimal antiviral efficacy with insignificant adverse events. Long-term follow-up data are warranted to ensure the sustained antiviral efficacy and long-term safety of sofosbuvir-based IFN-free therapy.