Real-world treatment outcome with protease inhibitor direct-acting antiviral in advanced hepatitis C cirrhosis: a REAL-C study

作者全名："Wong, Yu Jun; Tran, Sally; Huang, Chung-Feng; Hsu, Yao-Chun; Preda, Carmen; Toyoda, Hidenori; Liu, Joanne; Jun, Dae Won; Landis, Charles; Huang, Daniel Q.; Gila, Andrei; Negoita, Livia; Yasuda, Satoshi; Tseng, Cheng-Hao; Tsai, Pei-Chien; Uojima, Haruki; Nozaki, Akito; Chuma, Makoto; Atsukawa, Masanori; Ishigami, Masatoshi; Itokawa, Norio; Iio, Etsuko; Lam, Carla Pui-Mei; Watanabe, Tsunamasa; Asai, Akira; Yokohama, Keisuke; Abe, Hiroshi; Enomoto, Masaru; Kawada, Norifumi; Tamori, Akihiro; Lee, Dong Hyun; Jun, Mi Jung; Do, Son; Vo, Dang K. H.; Liu, Li; Li, Junyi; Ji, Fanpu; Wang, Wenjun; Li, Yu; Wang, Xiaozhong; Guo, Fen; Xu, Qiang; Jing, Liang; Ye, Qing; Pan, Hongying; Zhang, JiaJie; Wen, Xie; Wang, Qi; Ren, Hong; Cai, Dachuan; Shang, Jia; Liu, Junping; Lu, Chengzheng; Zang, Wenqian; Li, Jia; Niu, Junqi; Zhang, Mingyuan; Wu, Chao; Huang, Rui; Maeda, Mayumi; Nakanishi, Akiko; Yeh, Ming-Lun; Chuang, Wan-Long; Huang, Jee-Fu; Dai, ChiaYen; Ishikawa, Toru; Takaguchi, Koichi; Senoh, Tomonori; Trinh, Huy N.; Takahashi, Hirokazu; Eguchi, Yuichiro; Quek, Sabrina Xin Zi; Haga, Hiroaki; Ogawa, Eiichi; Wong, Grace; Buti, Maria; Fukunishi, Shinya; Ueno, Yoshiyuki; Yuen, Man-Fung; Tanaka, Yasuhito; Lim, Seng Gee; Cheung, Ramsey; Yu, Ming-Lung; Nguyen, Mindie H."

作者地址："[Wong, Yu Jun] Changi Gen Hosp, Gastroenterol & Hepatol, SingHealth, Singapore, Singapore; [Wong, Yu Jun] SingHealth Duke NUS Med Acad Clin Program, Singapore, Singapore; [Tran, Sally; Maeda, Mayumi; Nakanishi, Akiko; Cheung, Ramsey; Nguyen, Mindie H.] Stanford Univ, Div Gastroenterol & Hepatol, Dept Med, Med Ctr, Palo Alto, CA USA; [Huang, Chung-Feng; Tsai, Pei-Chien; Yeh, Ming-Lun; Chuang, Wan-Long; Huang, Jee-Fu; Dai, ChiaYen; Yu, Ming-Lung] Kaohsiung Med Univ, Kaohsiung Med Univ Hosp, Hepatobiliary Div, Dept Internal Med, Kaohsiung, Taiwan; [Huang, Chung-Feng; Tsai, Pei-Chien; Yeh, Ming-Lun; Chuang, Wan-Long; Huang, Jee-Fu; Dai, ChiaYen; Yu, Ming-Lung] Kaohsiung Med Univ, Hepatitis Res Ctr, Coll Med, Kaohsiung, Taiwan; [Huang, Chung-Feng; Tsai, Pei-Chien; Yeh, Ming-Lun; Chuang, Wan-Long; Huang, Jee-Fu; Dai, ChiaYen; Yu, Ming-Lung] Kaohsiung Med Univ, Cohort Res Ctr, Kaohsiung, Taiwan; [Huang, Chung-Feng; Tsai, Pei-Chien; Yeh, Ming-Lun; Chuang, Wan-Long; Huang, Jee-Fu; Dai, ChiaYen; Yu, Ming-Lung] Natl Sun Yat Sen Univ, Coll Med, Kaohsiung, Taiwan; [Hsu, Yao-Chun; Tseng, Cheng-Hao] E Da Canc Hosp, Div Gastroenterol & Hepatol, Dept Internal Med, Kaohsiung, Taiwan; [Preda, Carmen; Gila, Andrei] Clin Inst Fundeni, Gastroenterol & Hepatol, Bucharest, Romania; [Toyoda, Hidenori; Yasuda, Satoshi] Ogaki Municipal Hosp, Dept Gastroenterol & Hepatol, Ogaki, Japan; [Liu, Joanne; Landis, Charles] Univ Washington, Div Gastroenterol & Hepatol, Seattle, WA USA; [Jun, Dae Won] Hanyang Univ, Coll Med, Dept Internal Med, Seoul, South Korea; [Huang, Daniel Q.; Quek, Sabrina Xin Zi; Lim, Seng Gee] Natl Univ Singapore Hosp, Div Gastroenterol & Hepatol, Dept Med, Singapore, Singapore; [Huang, Daniel Q.; Lim, Seng Gee] Natl Univ Singapore, Yong Loo Lin Sch Med, Dept Med, Singapore, Singapore; [Uojima, Haruki] Kitasato Univ, Sch Med, Dept Gastroenterol Internal Med, Sagamihara, Kanagawa, Japan; [Nozaki, Akito; Chuma, Makoto] Yokohama City Univ, Med Ctr, Gastroenterol Ctr, Yokohama, Kanagawa, Japan; [Atsukawa, Masanori; Itokawa, Norio] Nippon Med Sch, Div Gastroenterol & Hepatol, Tokyo, Japan; [Ishigami, Masatoshi] Nagoya Univ, Grad Sch Med, Dept Gastroenterol & Hepatol, Nagoya, Aichi, Japan; [Iio, Etsuko; Tanaka, Yasuhito] Nagoya City Univ, Grad Sch Med Sci, Virol & Liver Unit, Nagoya, Aichi, Japan; [Lam, Carla Pui-Mei; Yuen, Man-Fung] Univ Hong Kong, Sch Clin Med, Dept Med, Hong Kong, Peoples R China; [Watanabe, Tsunamasa] St Marianna Univ, Sch Med, Div Gastroenterol & Hepatol, Kawasaki, Kanagawa, Japan; [Asai, Akira; Yokohama, Keisuke; Fukunishi, Shinya] Osaka Med Coll, Dept Internal Med 2, Osaka, Japan; [Abe, Hiroshi] Shinmatsudo Cent Gen Hosp, Div Gastroenterol & Hepatol, Chiba, Japan; [Enomoto, Masaru; Kawada, Norifumi; Tamori, Akihiro] Osaka Metropolitan Univ, Grad Sch Med, Dept Hepatol, Osaka, Japan; [Lee, Dong Hyun; Jun, Mi Jung] Good Gang An Hosp, Dept Gastroenterol, Busan, South Korea; [Do, Son; Vo, Dang K. H.] Digest Hlth Associates Texas, Plano, TX USA; [Liu, Li; Li, Junyi] Third Peoples Hosp Kunming City, Dept Hepatol, Kunming, Yunnan, Peoples R China; [Ji, Fanpu; Wang, Wenjun] Xi An Jiao Tong Univ, Affiliated Hosp 2, Dept Infect Dis, Xian, Peoples R China; [Li, Yu] Shaanxi Prov Peoples Hosp, Dept Infect Dis, Xian, Peoples R China; [Wang, Xiaozhong; Guo, Fen; Xu, Qiang] Xinjiang Med Univ, Affiliated Tradit Chinese Med Hosp, Urumqi, Peoples R China; [Jing, Liang; Ye, Qing] Third Cent Hosp Tianjin, Dept Gastroenterol & Hepatol, Tianjin, Peoples R China; [Pan, Hongying; Zhang, JiaJie] Zhejiang Univ, Zhejiang Prov Peoples Hosp, Dept Hepatol, Hangzhou, Peoples R China; [Wen, Xie; Wang, Qi] Capital Med Univ, Beijing Ditan Hosp, Ctr Liver Dis, Beijing, Peoples R China; [Ren, Hong; Cai, Dachuan] Chongqing Med Univ, Affiliated Hosp 2, Dept Infect Dis, Chongqing, Peoples R China; [Shang, Jia; Liu, Junping] Zhengzhou Univ, Henan Prov Peoples Hosp, Dept Infect Dis, Zhengzhou, Peoples R China; [Lu, Chengzheng; Zang, Wenqian; Li, Jia] Second Peoples Hosp Tianjin, Dept Gastroenterol & Hepatol, Tianjin, Peoples R China; [Niu, Junqi; Zhang, Mingyuan] First Hosp Jilin Univ, Dept Hepatol, Changchun, Peoples R China; [Wu, Chao; Huang, Rui] Nanjing Univ, Affiliated Hosp, Nanjing Drum Tower Hosp, Dept Infect Dis, Nanjing, Peoples R China; [Nakanishi, Akiko; Haga, Hiroaki; Ueno, Yoshiyuki] Yamagata Univ, Dept Gastroenterol, Fac Med, Yamagata, Peoples R China; [Ishikawa, Toru] Saiseikai Niigata Hosp, Dept Gastroenterol, Niigata, Japan; [Takaguchi, Koichi; Senoh, Tomonori] Kagawa Prefectural Cent Hosp, Dept Hepatol, Takamatsu, Kagawa, Japan; [Trinh, Huy N.] San Jose Gastroenterol, San Jose, CA USA; [Takahashi, Hirokazu; Eguchi, Yuichiro] Saga Univ Hosp, Ctr Liver, Saga, Japan; [Takahashi, Hirokazu; Eguchi, Yuichiro] Saga Univ, Div Endocrinol & Metab, Fac Med, Saga, Japan; [Ogawa, Eiichi] Kyushu Univ Hosp, Dept Gen Internal Med, Fukuoka, Japan; [Wong, Grace] Chinese Univ Hong Kong, Dept Med & Therapeut, Hong Kong, Peoples R China; [Wong, Grace; Yuen, Man-Fung] Chinese Univ Hong Kong, State Key Lab Digest Dis, Hong Kong, Peoples R China; [Buti, Maria] Hosp Univ Valle dHebron, Dept Internal Med, Liver Unit, Barcelona, Spain; [Buti, Maria] Univ Autonoma Barcelona, Barcelona, Spain; [Yuen, Man-Fung] Univ Hong Kong, State Key Lab Liver Res, Hong Kong, Peoples R China; [Tanaka, Yasuhito] Kumamoto Univ, Dept Gastroenterol & Hepatol, Fac Life Sci, Kumamoto, Japan; [Cheung, Ramsey] Vet Affairs Palo Alto Hlth Care Syst, Div Gastroenterol & Hepatol, Palo Alto, CA USA; [Nguyen, Mindie H.] Stanford Univ, Dept Epidemiol & Populat Hlth, Stanford, CA USA"

通信作者："Nguyen, MH (通讯作者)，Stanford Univ, Div Gastroenterol & Hepatol, Dept Med, Med Ctr, Palo Alto, CA USA.; Nguyen, MH (通讯作者)，Stanford Univ, Dept Epidemiol & Populat Hlth, Stanford, CA USA."

来源：HEPATOLOGY INTERNATIONAL

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001000895200003

JCR分区：Q1

影响因子：5.9

年份：2023

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：Real world; Effectiveness; Tolerability; Treatment; Outcome; Cirrhosis; Hepatitis C virus; Protease inhibitor; Direct-acting antiviral

摘要："IntroductionCurrent 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.MethodsWe 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.ResultsFrom 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).ConclusionTolerability 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."

基金机构："Kaohsiung Medical University Research Center Grant: Center for Liquid Biopsy [111006, 111004]"

基金资助正文：AcknowledgementsWe would like to acknowledge Kaohsiung Medical University Research Center Grant: Center for Liquid Biopsy and Cohort Research KMHK-DK(C)111006 and KMHK-DK(C)111004 for supporting Dr. Ming-Lung Yu.