Omata Masao, Nishiguchi Shuhei, Ueno Yoshiyuki, Mochizuki Hitoshi, Izumi Namiki, Ikeda Fusao, Toyoda Hidenori, Yokosuka Osamu, Nirei Kazushige, Genda Takuya, Umemura Takeji, Takehara Tetsuo, Sakamoto Naoya, Nishigaki Yoichi, Nakane Kunio, Toda Nobuo, Ide Tatsuya, Yanase Mikio, Hino Keisuke, Gao Bing, Garrison Kimberly L, Dvory-Sobol Hadas, Ishizaki Akinobu, Omote Masa, Brainard Diana, Knox Steven, Symonds William T, McHutchison John G, Yatsuhashi Hiroshi, Mizokami Masashi
Yamanashi Prefectural Hospital Organization, Yamanashi, Japan.
J Viral Hepat. 2014 Nov;21(11):762-8. doi: 10.1111/jvh.12312. Epub 2014 Sep 8.
Genotype 2 hepatitis C virus (HCV) accounts for up to 30% of chronic HCV infections in Japan. The standard of care for patients with genotype 2 HCV - peginterferon and ribavirin for 24 weeks - is poorly tolerated, especially among older patients and those with advanced liver disease. We conducted a phase 3, open-label study to assess the efficacy and safety of an all-oral combination of the NS5B polymerase inhibitor sofosbuvir and ribavirin in patients with chronic genotype 2 HCV infection in Japan. We enrolled 90 treatment-naïve and 63 previously treated patients at 20 sites in Japan. All patients received sofosbuvir 400 mg plus ribavirin (weight-based dosing) for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after therapy (SVR12). Of the 153 patients enrolled and treated, 60% had HCV genotype 2a, 11% had cirrhosis, and 22% were over the aged 65 or older. Overall, 148 patients (97%) achieved SVR12. Of the 90 treatment-naïve patients, 88 (98%) achieved SVR12, and of the 63 previously treated patients, 60 (95%) achieved SVR12. The rate of SVR12 was 94% in patients with cirrhosis and in those aged 65 and older. No patients discontinued study treatment due to adverse events. The most common adverse events were nasopharyngitis, anaemia and headache. Twelve weeks of sofosbuvir and ribavirin resulted in high rates of SVR12 in treatment-naïve and previously treated patients with chronic genotype 2 HCV infection. The treatment was safe and well tolerated by patients, including the elderly and those with cirrhosis.
2型丙型肝炎病毒（HCV）在日本慢性HCV感染中占比高达30%。2型HCV患者的标准治疗方案——聚乙二醇干扰素和利巴韦林联合治疗24周——耐受性较差，尤其是在老年患者和晚期肝病患者中。我们开展了一项3期开放标签研究，以评估NS5B聚合酶抑制剂索磷布韦与利巴韦林的全口服联合方案在日本慢性2型HCV感染患者中的疗效和安全性。我们在日本的20个地点招募了90例初治患者和63例经治患者。所有患者接受索磷布韦400mg加利巴韦林（基于体重给药）治疗12周。主要终点是治疗后12周的持续病毒学应答（SVR12）。在153例入组并接受治疗的患者中，60%为2a型HCV，11%有肝硬化，22%年龄在65岁及以上。总体而言，148例患者（97%）实现了SVR12。在90例初治患者中，88例（98%）实现了SVR12，在63例经治患者中，60例（95%）实现了SVR12。肝硬化患者和65岁及以上患者的SVR12率为94%。没有患者因不良事件而停止研究治疗。最常见的不良事件是鼻咽炎、贫血和头痛。索磷布韦和利巴韦林治疗12周在初治和经治的慢性2型HCV感染患者中导致了较高的SVR12率。该治疗对患者安全且耐受性良好，包括老年人和肝硬化患者。
