Effect of treatment periods on efficacy of glecaprevir and pibrentasvir in chronic hepatitis C: A nationwide, prospective, multicenter study

IF 1.7 Q3 GASTROENTEROLOGY & HEPATOLOGY

JGH Open Pub Date : 2024-04-25 DOI:10.1002/jgh3.13068

Atsuhiro Morita, Nobuharu Tamaki, Haruhiko Kobashi, Nami Mori, Keiji Tsuji, Shintaro Takaki, Chitomi Hasebe, Takehiro Akahane, Hironori Ochi, Toshie Mashiba, Naohito Urawa, Hideki Fujii, Akeri Mitsuda, Masahiko Kondo, Chikara Ogawa, Yasushi Uchida, Ryoichi Narita, Hiroyuki Marusawa, Yoshihito Kubotsu, Tomomichi Matsushita, Masaya Shigeno, Hideo Yoshida, Katsuaki Tanaka, Eisuke Okamoto, Toyotaka Kasai, Toru Ishii, Kazuhiko Okada, Masayuki Kurosaki, Namiki Izumi

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Abstract

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 (P = 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.

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治疗周期对格列卡韦和匹布伦达韦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

背景和目的对于慢性丙型肝炎患者，日本已批准对慢性肝炎（非肝硬化）患者进行为期 8 周的格列卡韦和匹布恩达韦（GLE/PIB）治疗，对肝硬化患者进行为期 12 周的格列卡韦和匹布恩达韦（GLE/PIB）治疗。然而，对肝硬化治疗 8 周是否会降低疗效尚未进行充分研究。方法这项前瞻性、全国性、多中心队列研究纳入了 1275 名接受 GLE/PIB 治疗的慢性丙型肝炎患者。研究调查了肝纤维化和治疗时间对 GLE/PIB 治疗效率的影响。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。研究还探讨了治疗周期和肝纤维化对 12 周治疗后 SVR 率的影响。结果治疗 8 周的慢性肝炎患者、治疗 12 周的慢性肝炎患者、治疗 8 周的肝硬化患者和治疗 12 周的肝硬化患者的 SVR 率分别为 98.9%（800/809）、100%（87/87）、100%（166/166）和 99.1%（211/213），且各组间无差异（P = 0.4）。结论 GLE/PIB 疗法治疗慢性丙型肝炎疗效显著，与肝纤维化状态和治疗周期无关。GLE/PIB治疗的疗程可根据现有模式进行选择，无论做出何种决定，都能获得较高的SVR率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

JGH Open GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

3.40

自引率

0.00%

发文量

143

审稿时长

7 weeks