The combination of elbasvir and grazoprevir for the treatment of chronic HCV infection in Japanese patients: a randomized phase II/III study.
The combination of elbasvir and grazoprevir for the treatment of chronic HCV infection in Japanese patients: a randomized phase II/III study.
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DOI：
10.1007/s00535-016-1285-y
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发表时间：
2017-04
影响因子：
6.3
通讯作者：
Wahl J
中科院分区：
文献类型：
--
作者：
Kumada H;Suzuki Y;Karino Y;Chayama K;Kawada N;Okanoue T;Itoh Y;Mochida S;Toyoda H;Yoshiji H;Takaki S;Yatsuzuka N;Yodoya E;Iwasa T;Fujimoto G;Robertson MN;Black S;Caro L;Wahl J
在主要在美国和欧洲进行的试验中，Elbasvir（EBR）联合Grazoprevir（GZR）已证明对丙型肝炎病毒（HCV）感染患者有效。我们研究了EBR联合GZR治疗日本慢性HCV感染（伴或不伴肝硬化）患者的安全性和有效性。这项研究分两部分进行。在第一部分中，非糖尿病患者按1：1的比例随机接受EBR（50 mg）联合GZR（50或100 mg）每日一次，持续12周。在第2部分中，非癫痫患者以3：1的比例随机接受EBR（50 mg）和GZR（100 mg，在第1部分中确定）立即或延迟治疗12周;癫痫患者接受开放标签立即治疗。主要疗效终点是研究治疗完成后12周的持续病毒学应答率。在第1部分中，63例患者随机接受EBR联合GZR治疗，剂量为50 mg（n = 31）或100 mg（n = 32）。GZR 50 mg剂量组的SVR 12率为100%，GZR 100 mg剂量组的SVR 12率为96.8%。两组的耐受性相似。在第2部分中，301例非脑卒中患者随机接受立即治疗（n = 227）或延迟治疗（n = 74），35例脑卒中患者入组。治疗后即刻，非风湿性关节炎和风湿性关节炎患者的SVR 12阳性率分别为96.5%和97.1%。立即和延迟治疗的安全性基本相似。EBR联合GZR治疗12周在日本慢性HCV感染患者中有效且耐受性良好。NCT 02203149。本文的在线版本（doi：10.1007/s 00535 -016-1285-y）包含补充材料，可供授权用户使用。
Elbasvir (EBR) in combination with grazoprevir (GZR) has demonstrated efficacy in patients with hepatitis C virus (HCV) infections in trials primarily conducted in the USA and Europe. We investigated the safety and efficacy of EBR in combination with GZR in Japanese patients with chronic HCV infection, with or without cirrhosis. The study was conducted in two parts. In part 1, noncirrhotic patients were randomized 1:1 to receive EBR (50 mg) in combination with GZR (50 or 100 mg) once daily for 12 weeks. In part 2, noncirrhotic patients were randomized 3:1 to receive immediate or deferred treatment with EBR (50 mg) and GZR (100 mg, determined in part 1) for 12 weeks; cirrhotic patients received open-label immediate treatment. The primary efficacy end point was the rate of sustained virologic response 12 weeks after completion of the study treatment. In part 1, 63 patients were randomized to receive EBR in combination with GZR at a dose of 50 mg (n = 31) or 100 mg (n = 32). The SVR12 rates were 100% with GZR at a dose of 50 mg and 96.8% with GZR at a dose of 100 mg. Tolerability was similar in both arms. In part 2, 301 noncirrhotic patients were randomized to receive immediate treatment (n = 227) or deferred treatment (n = 74), and 35 cirrhotic patients were enrolled. The SVR12 rates were 96.5% and 97.1% after immediate treatment in noncirrhotic and cirrhotic patients respectively. Safety was generally similar between immediate and deferred treatment. Treatment with EBR in combination with GZR for 12 weeks is effective and well tolerated in Japanese patients with chronic HCV infection. NCT02203149. The online version of this article (doi:10.1007/s00535-016-1285-y) contains supplementary material, which is available to authorized users.