Erschienen in:
05.06.2023 | Original Article
Real-world treatment outcome with protease inhibitor direct-acting antiviral in advanced hepatitis C cirrhosis: a REAL-C study
verfasst von:
Yu Jun Wong, Sally Tran, Chung-Feng Huang, Yao-Chun Hsu, Carmen Preda, Hidenori Toyoda, Joanne Liu, Dae Won Jun, Charles Landis, Daniel Q. Huang, Andrei Gila, Livia Negoita, Satoshi Yasuda, Cheng-Hao Tseng, Pei-Chien Tsai, Haruki Uojima, Akito Nozaki, Makoto Chuma, Masanori Atsukawa, Masatoshi Ishigami, Norio Itokawa, Etsuko Iio, Carla Pui-Mei Lam, Tsunamasa Watanabe, Akira Asai, Keisuke Yokohama, Hiroshi Abe, Masaru Enomoto, Norifumi Kawada, Akihiro Tamori, Dong Hyun Lee, Mi Jung Jun, Son Do, Dang K. H. Vo, Li Liu, Junyi Li, Fanpu Ji, Wenjun Wang, Yu Li, Xiaozhong Wang, Fen Guo, Qiang Xu, Liang Jing, Qing Ye, Hongying Pan, JiaJie Zhang, Xie Wen, Qi Wang, Hong Ren, Dachuan Cai, Jia Shang, Junping Liu, Chengzheng Lu, Wenqian Zang, Jia Li, Junqi Niu, Mingyuan Zhang, Chao Wu, Rui Huang, Mayumi Maeda, Akiko Nakanishi, Ming-Lun Yeh, Wan-Long Chuang, Jee-Fu Huang, ChiaYen Dai, Toru Ishikawa, Koichi Takaguchi, Tomonori Senoh, Huy N. Trinh, Hirokazu Takahashi, Yuichiro Eguchi, Sabrina Xin Zi Quek, Hiroaki Haga, Eiichi Ogawa, Grace Wong, Maria Buti, Shinya Fukunishi, Yoshiyuki Ueno, Man-Fung Yuen, Yasuhito Tanaka, Seng Gee Lim, Ramsey Cheung, Ming-Lung Yu, Mindie H. Nguyen
Erschienen in:
Hepatology International
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Ausgabe 5/2023
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Abstract
Introduction
Current guidelines discourage the use of direct-acting antiviral (DAA) containing protease-inhibitor (PI) in advanced HCV cirrhosis. We aimed to compare the real-world tolerability of PI vs. non-PI DAA regimens in this population.
Methods
We identified advanced cirrhosis patients treated with DAA from the REAL-C registry. The primary outcome was significant worsening or improvement in CPT or MELD scores following DAA treatment.
Results
From the REAL-C registry of 15,837 patients, we included 1077 advanced HCV cirrhosis patients from 27 sites. 42% received PI-based DAA. Compared to non-PI group, the PI group was older, had higher MELD and higher percentage with kidney disease. Inverse probability of treatment weighting (IPTW; matching on age, sex, history of clinical decompensation, MELD, platelet, albumin, Asia site, Asian ethnicity, hypertension, hemoglobin, genotype, liver cancer, ribavirin) was used to balance the two groups. In the IPTW-matched cohorts, the PI and non-PI groups had similar SVR12 (92.9% vs. 90.7%, p = 0.30), similar percentages of significant worsening in CTP or MELD scores at posttreatment week 12 and 24 (23.9% vs. 13.1%, p = 0.07 and 16.5% vs. 14.6%, p = 0.77), and similar frequency of new HCC, decompensating event, and death by posttreatment week 24. In multivariable analysis, PI-based DAA was not associated with significant worsening (adjusted odds ratio = 0.82, 95% CI 0.38–1.77).
Conclusion
Tolerability and treatment outcomes were not significantly different in advanced HCV cirrhosis treated with PI-based (vs. non-PI) DAA up to CTP-B or MELD score of 15. Safety of PI-based DAA in those with CTP-C or MELD beyond 15 awaits further data.