治疗周期对glecaprevir和pibrentasvir治疗慢性丙型肝炎疗效的影响：一项全国性、前瞻性、多中心研究。
Effect of treatment periods on efficacy of glecaprevir and pibrentasvir in chronic hepatitis C: A nationwide, prospective, multicenter study.
作者信息
Morita Atsuhiro, Tamaki Nobuharu, Kobashi Haruhiko, Mori Nami, Tsuji Keiji, Takaki Shintaro, Hasebe Chitomi, Akahane Takehiro, Ochi Hironori, Mashiba Toshie, Urawa Naohito, Fujii Hideki, Mitsuda Akeri, Kondo Masahiko, Ogawa Chikara, Uchida Yasushi, Narita Ryoichi, Marusawa Hiroyuki, Kubotsu Yoshihito, Matsushita Tomomichi, Shigeno Masaya, Yoshida Hideo, Tanaka Katsuaki, Okamoto Eisuke, Kasai Toyotaka, Ishii Toru, Okada Kazuhiko, Kurosaki Masayuki, Izumi Namiki
机构信息
Department of Gastroenterology Japanese Red Cross Kyoto Daini Hospital Kyoto Japan.
Department of Gastroenterology and Hepatology Musashino Red Cross Hospital Tokyo Japan.
出版信息
JGH Open. 2024 Apr 25;8(4):e13068. doi: 10.1002/jgh3.13068. eCollection 2024 Apr.
BACKGROUND AND AIM
In patients with chronic hepatitis C, 8 weeks of glecaprevir and pibrentasvir (GLE/PIB) treatment for chronic hepatitis (non-cirrhosis) and 12 weeks for cirrhosis have been approved in Japan. However, whether 8 weeks of treatment for cirrhosis may reduce treatment efficacy has not been adequately investigated.
METHODS
This prospective, nationwide, multicenter cohort study enrolled 1275 patients with chronic hepatitis C who received GLE/PIB therapy. The effect of liver fibrosis and treatment periods on the efficiency of GLE/PIB therapy was investigated. The primary endpoint was the sustained virological response (SVR) rate in patients with chronic hepatitis (non-cirrhosis) and cirrhosis. The association between treatment periods and liver fibrosis on the SVR after 12 weeks of treatment rate was investigated.
RESULTS
The SVR rates in patients with chronic hepatitis with 8 weeks of treatment, chronic hepatitis with 12 weeks of treatment, cirrhosis with 8 weeks of treatment, and cirrhosis with 12 weeks of treatment were 98.9% (800/809), 100% (87/87), 100% (166/166), and 99.1% (211/213), respectively, and were was not different among these groups ( = 0.4).
CONCLUSION
GLE/PIB therapy for chronic hepatitis C had high efficacy regardless of liver fibrosis status and treatment periods. Periods of GLE/PIB therapy could be chosen with available modalities, and high SVR rates could be achieved regardless of the decision.
背景与目的
在日本，已批准使用glecaprevir和pibrentasvir（GLE/PIB）对慢性丙型肝炎患者进行治疗，其中慢性肝炎（非肝硬化）患者的疗程为8周，肝硬化患者为12周。然而，对于肝硬化患者进行8周治疗是否会降低治疗效果，尚未进行充分研究。
方法
这项前瞻性、全国性、多中心队列研究纳入了1275例接受GLE/PIB治疗的慢性丙型肝炎患者。研究了肝纤维化和治疗疗程对GLE/PIB治疗效果的影响。主要终点是慢性肝炎（非肝硬化）和肝硬化患者的持续病毒学应答（SVR）率。研究了治疗疗程与肝纤维化对治疗12周后SVR率的关联。
结果
接受8周治疗的慢性肝炎患者、接受12周治疗的慢性肝炎患者、接受8周治疗的肝硬化患者以及接受12周治疗的肝硬化患者的SVR率分别为98.9%（800/809）、100%（87/87）、100%（166/166）和99.1%（211/213），这些组之间无差异（P=0.4）。
结论
无论肝纤维化状态和治疗疗程如何，GLE/PIB治疗慢性丙型肝炎均具有高效性。可根据现有方式选择GLE/PIB治疗疗程，无论如何决定均可实现高SVR率。
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