Real-world Effectiveness and Tolerability of Interferon-free Direct-acting Antiviral for 15,849 Patients with Chronic Hepatitis C: A Multinational Cohort Study.

IF 3.1 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Journal of Clinical and Translational Hepatology Pub Date : 2024-07-28 Epub Date: 2024-06-17 DOI:10.14218/JCTH.2024.00089

Fanpu Ji, Sally Tran, Eiichi Ogawa, Chung-Feng Huang, Takanori Suzuki, Yu Jun Wong, Hidenori Toyoda, Dae Won Jun, Liu Li, Haruki Uojima, Akito Nozaki, Makoto Chuma, Cheng-Hao Tseng, Yao-Chun Hsu, Masatoshi Ishigami, Takashi Honda, Masanori Atsukawa, Hiroaki Haga, Masaru Enomoto, Huy Trinh, Carmen Monica Preda, Phillip Vutien, Charles Landis, Dong Hyun Lee, Tsunamasa Watanabe, Hirokazu Takahashi, Hiroshi Abe, Akira Asai, Yuichiro Eguchi, Jie Li, Xiaozhong Wang, Jia Li, Junping Liu, Jing Liang, Carla Pui-Mei Lam, Rui Huang, Qing Ye, Hongying Pan, Jiajie Zhang, Dachuan Cai, Qi Wang, Daniel Q Huang, Grace Wong, Vincent Wai-Sun Wong, Junyi Li, Son Do, Norihiro Furusyo, Makoto Nakamuta, Hideyuki Nomura, Eiji Kajiwara, Eileen L Yoon, Sang Bong Ahn, Koichi Azuma, Kazufumi Dohmen, Jihyun An, Do Seon Song, Hyun Chin Cho, Akira Kawano, Toshimasa Koyanagi, Aritsune Ooho, Takeaki Satoh, Kazuhiro Takahashi, Ming-Lun Yeh, Pei-Chien Tsai, Satoshi Yasuda, Yunyu Zhao, Yishan Liu, Tomomi Okubo, Norio Itokawa, Mi Jung Jun, Toru Ishikawa, Koichi Takaguchi, Tomonori Senoh, Mingyuan Zhang, Changqing Zhao, Raluca Ioana Alecu, Wei Xuan Tay, Pooja Devan, Joanne Kimiko Liu, Ritsuzo Kozuka, Elena Vargas-Accarino, Ai-Thien Do, Mayumi Maeda, Wan-Long Chuang, Jee-Fu Huang, Chia-Yen Dai, Ramsey Cheung, Maria Buti, Junqi Niu, Wen Xie, Hong Ren, Seng Gee Lim, Chao Wu, Man-Fung Yuen, Jia Shang, Qiang Zhu, Yoshiyuki Ueno, Yasuhito Tanaka, Jun Hayashi, Ming-Lung Yu, Mindie H Nguyen

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引用次数: 0

Abstract

Background and aims: As practice patterns and hepatitis C virus (HCV) genotypes (GT) vary geographically, a global real-world study from both East and West covering all GTs can help inform practice policy toward the 2030 HCV elimination goal. This study aimed to assess the effectiveness and tolerability of DAA treatment in routine clinical practice in a multinational cohort for patients infected with all HCV GTs, focusing on GT3 and GT6.

Methods: We analyzed the sustained virological response (SVR12) of 15,849 chronic hepatitis C patients from 39 Real-World Evidence from the Asia Liver Consortium for HCV clinical sites in Asia Pacific, North America, and Europe between 07/01/2014-07/01/2021.

Results: The mean age was 62±13 years, with 49.6% male. The demographic breakdown was 91.1% Asian (52.9% Japanese, 25.7% Chinese/Taiwanese, 5.4% Korean, 3.3% Malaysian, and 2.9% Vietnamese), 6.4% White, 1.3% Hispanic/Latino, and 1% Black/African-American. Additionally, 34.8% had cirrhosis, 8.6% had hepatocellular carcinoma (HCC), and 24.9% were treatment-experienced (20.7% with interferon, 4.3% with direct-acting antivirals). The largest group was GT1 (10,246 [64.6%]), followed by GT2 (3,686 [23.2%]), GT3 (1,151 [7.2%]), GT6 (457 [2.8%]), GT4 (47 [0.3%]), GT5 (1 [0.006%]), and untyped GTs (261 [1.6%]). The overall SVR12 was 96.9%, with rates over 95% for GT1/2/3/6 but 91.5% for GT4. SVR12 for GT3 was 95.1% overall, 98.2% for GT3a, and 94.0% for GT3b. SVR12 was 98.3% overall for GT6, lower for patients with cirrhosis and treatment-experienced (TE) (93.8%) but ≥97.5% for treatment-naive patients regardless of cirrhosis status. On multivariable analysis, advanced age, prior treatment failure, cirrhosis, active HCC, and GT3/4 were independent predictors of lower SVR12, while being Asian was a significant predictor of achieving SVR12.

Conclusions: In this diverse multinational real-world cohort of patients with various GTs, the overall cure rate was 96.9%, despite large numbers of patients with cirrhosis, HCC, TE, and GT3/6. SVR12 for GT3/6 with cirrhosis and TE was lower but still excellent (>91%).

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针对 15,849 名慢性丙型肝炎患者的无干扰素直接作用抗病毒药物的实际有效性和耐受性：一项多国队列研究。

背景和目的：由于实践模式和丙型肝炎病毒（HCV）基因型（GT）因地域而异，一项涵盖东西方所有GT的全球真实世界研究有助于为实现2030年消除HCV的目标提供实践政策信息。本研究旨在评估DAA治疗在常规临床实践中对所有HCV GTs感染者的有效性和耐受性，重点是GT3和GT6：我们分析了2014年1月7日至2021年1月7日期间亚太、北美和欧洲39个亚洲肝病联盟HCV临床研究机构的15849名慢性丙型肝炎患者的持续病毒学应答（SVR12）：平均年龄为 62±13 岁，男性占 49.6%。亚裔人口占 91.1%（52.9% 日本人、25.7% 中国人/台湾人、5.4% 韩国人、3.3% 马来西亚人和 2.9% 越南人），白人占 6.4%，西班牙裔/拉丁美洲人占 1.3%，黑人/非洲裔美国人占 1%。此外，34.8%患有肝硬化，8.6%患有肝细胞癌（HCC），24.9%有治疗经验（20.7%使用干扰素，4.3%使用直接作用抗病毒药物）。最大的群体是 GT1（10 246 [64.6%]），其次是 GT2（3 686 [23.2%]）、GT3（1 151 [7.2%]）、GT6（457 [2.8%]）、GT4（47 [0.3%]）、GT5（1 [0.006%]）和未分型的 GTs（261 [1.6%]）。总体 SVR12 为 96.9%，GT1/2/3/6 的 SVR12 率超过 95%，但 GT4 为 91.5%。GT3的SVR12总体为95.1%，GT3a为98.2%，GT3b为94.0%。GT6的SVR12总体为98.3%，肝硬化患者和有治疗经验（TE）患者的SVR12较低（93.8%），但无论肝硬化状况如何，未接受治疗患者的SVR12均≥97.5%。在多变量分析中，高龄、既往治疗失败、肝硬化、活动性 HCC 和 GT3/4 是 SVR12 较低的独立预测因素，而亚裔则是 SVR12 的重要预测因素：在这个由不同GTs患者组成的跨国真实世界队列中，尽管有大量肝硬化、HCC、TE和GT3/6患者，但总体治愈率为96.9%。GT3/6伴有肝硬化和TE的SVR12较低，但仍然很好（>91%）。

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

Journal of Clinical and Translational Hepatology GASTROENTEROLOGY & HEPATOLOGY-

CiteScore

6.40

自引率

2.80%

发文量

496