Ahn S H, Lim Y S, Lee K S, Paik S W, Lee Y J, Jeong S H, Kim J H, Yoon S K, Yim H J, Tak W Y, Han S Y, Yang J C, Mo H, Mathias A, Han L, Knox S J, Brainard D M, Kim Y J, Byun K S, Kim Y S, Heo J, Han K H
Yonsei University College of Medicine, Seoul-Korea, South Korea.
Asan Medical Center, University of Ulsan College of Medicine, Seoul-Korea, South Korea.
J Viral Hepat. 2016 May;23(5):358-65. doi: 10.1111/jvh.12499. Epub 2016 Feb 10.
In Korea, patients with chronic hepatitis C virus (HCV) infection are typically treated with pegylated interferon-alpha plus ribavirin, but interferons are contraindicated in many patients and are often poorly tolerated, particularly by the elderly and those with advanced liver disease. No interferon-free treatment regimens are approved in Korea. Sofosbuvir is an oral nucleotide analog inhibitor of the HCV nonstructural 5B RNA polymerase. It is approved in the USA, European Union and Japan for treating a number of HCV genotypes, including genotype 2. Genotype 2 has a seroprevalence of 38-46% in Korea. This single-arm, phase 3b study (NCT02021643) examined the efficacy and safety of sofosbuvir plus ribavirin (12-week duration) in chronic genotype 2 HCV-infected treatment-naive and treatment-experienced Korean patients with and without cirrhosis. The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 97% (125/129), with 96% (101/105) of treatment-naive and 100% (24/24) of treatment-experienced patients achieving SVR12. Two patients experienced virologic failure (n = 1, on-treatment failure; n = 1, relapse). No patient discontinued study treatment due to an adverse event (AE). The most common treatment-emergent AEs were headache (18%, 23/129) and pruritus (15%, 19/129). Few patients had grade 3 AEs (5%, 6/129) or grade 3 laboratory abnormalities (12%, 15/129). No grade 4 AE was reported. These data suggest that 12 weeks of treatment with the all-oral, interferon-free regimen of sofosbuvir plus ribavirin is effective and well tolerated in Korean patients with chronic genotype 2 HCV infection.
在韩国，慢性丙型肝炎病毒（HCV）感染患者通常接受聚乙二醇化干扰素-α联合利巴韦林治疗，但许多患者禁用干扰素，且往往耐受性较差，尤其是老年人和晚期肝病患者。韩国尚未批准无干扰素治疗方案。索磷布韦是一种HCV非结构5B RNA聚合酶的口服核苷酸类似物抑制剂。它在美国、欧盟和日本被批准用于治疗多种HCV基因型，包括2型。2型在韩国的血清流行率为38%-46%。这项单臂3b期研究（NCT02021643）考察了索磷布韦联合利巴韦林（疗程12周）对韩国慢性2型HCV感染、未接受过治疗和接受过治疗的患者（有或无肝硬化）的疗效和安全性。停药12周后持续病毒学应答（SVR12）的患者比例为97%（125/129），其中未接受过治疗的患者为96%（101/105），接受过治疗的患者为100%（24/24）达到SVR12。两名患者出现病毒学失败（1例为治疗期间失败；1例为复发）。没有患者因不良事件（AE）而停止研究治疗。最常见的治疗中出现的AE是头痛（18%，23/129）和瘙痒（15%，19/129）。很少有患者出现3级AE（5%，6/129）或3级实验室异常（12%，15/129）。未报告4级AE。这些数据表明，索磷布韦联合利巴韦林的全口服、无干扰素方案治疗12周对韩国慢性2型HCV感染患者有效且耐受性良好。
