Lim Young-Suk, Ahn Sang Hoon, Lee Kwan Sik, Paik Seung Woon, Lee Youn-Jae, Jeong Sook-Hyang, Kim Ju-Hyun, Yoon Seung Kew, Yim Hyung Joon, Tak Won Young, Han Sang-Young, Yang Jenny C, Mo Hongmei, Garrison Kimberly L, Gao Bing, Knox Steven J, Pang Phillip S, Kim Yoon Jun, Byun Kwan-Soo, Kim Young Seok, Heo Jeong, Han Kwang-Hyub
Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.
Hepatol Int. 2016 Nov;10(6):947-955. doi: 10.1007/s12072-016-9726-5. Epub 2016 May 20.
The standard-of-care regimen for chronic hepatitis C virus (HCV) infection in Korea, pegylated-interferon-alpha plus ribavirin, is poorly tolerated. Ledipasvir/sofosbuvir is a two-drug, fixed-dose combination tablet approved in the USA, European Union, and Japan for chronic genotype 1 HCV infection.
This single-arm, phase IIIb study (NCT02021656) investigated the efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination tablet for 12 weeks in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 HCV with or without compensated cirrhosis.
The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 99 % (92/93), with rates of 100 % (46/46) and 98 % (46/47) in treatment-naïve and treatment-experienced patients, respectively. There were no on-treatment failures. One patient relapsed after the end of treatment. The most common treatment-emergent adverse events were headache (8 %, 7/93) and fatigue (6 %, 6/93). There were no grade 3 or 4 adverse events, seven grade 3 laboratory abnormalities, and one premature discontinuation of study treatment (due to nonserious mouth ulceration). None of the three reported serious adverse events were related to treatment.
These data suggest that 12 weeks of ledipasvir/sofosbuvir is effective and well tolerated in treatment-naïve and treatment-experienced Korean patients with chronic genotype 1 HCV infection.
韩国慢性丙型肝炎病毒（HCV）感染的标准治疗方案是聚乙二醇化干扰素-α联合利巴韦林，但耐受性较差。来迪派韦/索磷布韦是一种固定剂量的复方片剂，由两种药物组成，已在美国、欧盟和日本获批用于治疗慢性基因1型HCV感染。
这项单臂IIIb期研究（NCT02021656）调查了来迪派韦/索磷布韦固定剂量复方片剂治疗12周对初治和经治的、慢性感染基因1型HCV且有无代偿性肝硬化的韩国患者的疗效和安全性。
治疗停药12周后持续病毒学应答（SVR12）的患者比例为99%（92/93），其中初治患者和经治患者的SVR12率分别为100%（46/46）和98%（46/47）。治疗期间无失败病例。1例患者在治疗结束后复发。最常见的治疗中出现的不良事件为头痛（8%，7/93）和疲劳（6%，6/93）。无3级或4级不良事件，有7例3级实验室异常，1例患者因不严重的口腔溃疡提前终止研究治疗。报告的3例严重不良事件均与治疗无关。
这些数据表明，对于初治和经治的慢性基因1型HCV感染韩国患者，12周的来迪派韦/索磷布韦治疗有效且耐受性良好。
