Kawaguchi Takumi, Komori Atsumasa, Fujisaki Kunio, Nishiguchi Shuhei, Kato Michio, Takagi Hitoshi, Tanaka Yasuhito, Notsumata Kazuo, Mita Eiji, Nomura Hideyuki, Shibatoge Mitsushige, Takaguchi Koichi, Hattori Toshihiro, Sata Michio, Koike Kazuhiko
Department of Medicine, Division of Gastroenterology, Kurume University School of Medicine, Kurume, Fukuoka 830-0011, Japan.
Clinical Research Center, National Hospital Organization (NHO) Nagasaki Medical Center, Omura, Nagasaki 856-8562, Japan.
Exp Ther Med. 2019 Jul;18(1):596-604. doi: 10.3892/etm.2019.7616. Epub 2019 May 24.
To investigate the efficacy of eltrombopag for the treatment of thrombocytopenia in patients with chronic hepatitis C, a phase II, single-arm, open-label study with a 9-week pre-antiviral phase was conducted, followed by a 48-week antiviral phase and a 24-week follow-up phase. The proportion of patients who achieved a platelet count threshold, the proportion of patients who maintained a platelet count >50,000/µl, sustained virological response (SVR) rates and safety parameters were evaluated. Of the 45 enrolled patients (median age, 59 years; median platelet count, 63,000/µl; 98% with Child-Pugh class A), 43 (96%) achieved the platelet count threshold during the pre-antiviral phase. A total of 13 patients (29%) experienced ≥1 adverse event (AE), of which headache and vomiting were the most common, and 41 patients (mostly receiving eltrombopag 12.5 mg or 25 mg) entered the antiviral phase, of which 36 (88%) maintained the platelet count threshold; no patient platelet count decreased below 25,000/µl. Nine patients (22%) achieved an SVR at the 24-week follow-up. Grade ≥3 AEs occurred in 25 patients (61%). A total of 8 serious AEs occurred in five patients (12%). No mortality, thromboembolic events (TEEs), or cataract progression were reported. Eltrombopag increased the platelet count in chronic hepatitis C virus-infected patients with cirrhosis and thrombocytopenia and enabled them to initiate and complete interferon-based antiviral therapy (NCT01636778; first submitted: July 05, 2012).
为研究艾曲泊帕治疗慢性丙型肝炎患者血小板减少症的疗效，开展了一项II期单臂开放标签研究，先进行为期9周的抗病毒前期，随后是48周的抗病毒期和24周的随访期。评估达到血小板计数阈值的患者比例、血小板计数维持>50,000/µl的患者比例、持续病毒学应答（SVR）率和安全性参数。在45例入组患者中（中位年龄59岁；中位血小板计数63,000/µl；98%为Child-Pugh A级），43例（96%）在抗病毒前期达到血小板计数阈值。共有13例患者（29%）发生≥1次不良事件（AE），其中头痛和呕吐最为常见，41例患者（大多接受12.5 mg或25 mg艾曲泊帕）进入抗病毒期，其中36例（88%）维持血小板计数阈值；无患者血小板计数降至25,000/µl以下。9例患者（22%）在24周随访时达到SVR。25例患者（61%）发生≥3级AE。5例患者（12%）共发生8次严重AE。未报告死亡、血栓栓塞事件（TEE）或白内障进展情况。艾曲泊帕可提高慢性丙型肝炎病毒感染的肝硬化和血小板减少症患者的血小板计数，并使他们能够启动和完成基于干扰素的抗病毒治疗（NCT01636778；首次提交：2012年7月5日）。
