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Erschienen in: Hepatology International 5/2023

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 | 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.
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Literatur
1.
Zurück zum Zitat Polaris Observatory HCV Collaborators. Global change in hepatitis C virus prevalence and cascade of care between 2015 and 2020: a modelling study. Lancet Gastroenterol Hepatol 2022;7(5):396–415CrossRef Polaris Observatory HCV Collaborators. Global change in hepatitis C virus prevalence and cascade of care between 2015 and 2020: a modelling study. Lancet Gastroenterol Hepatol 2022;7(5):396–415CrossRef
2.
Zurück zum Zitat Kiser JJ. Safety of hepatitis C viral protease inhibitors in compensated cirrhotic: lingering concerns put to rest? Clin Infect Dis 2019;69(10):1665–1666CrossRefPubMed Kiser JJ. Safety of hepatitis C viral protease inhibitors in compensated cirrhotic: lingering concerns put to rest? Clin Infect Dis 2019;69(10):1665–1666CrossRefPubMed
4.
Zurück zum Zitat AASLD-IDSA HCV Guidance Panel. Hepatitis C guidance 2018 update: AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus infection. Clin Infect Dis 2018;67(10):1477–1492CrossRef AASLD-IDSA HCV Guidance Panel. Hepatitis C guidance 2018 update: AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus infection. Clin Infect Dis 2018;67(10):1477–1492CrossRef
5.
Zurück zum Zitat EASL Governing Board representative. Panel members: EASL recommendations on treatment of hepatitis C: final update of the series☆. J Hepatol 2020;73(5):1170–1218CrossRef EASL Governing Board representative. Panel members: EASL recommendations on treatment of hepatitis C: final update of the series☆. J Hepatol 2020;73(5):1170–1218CrossRef
7.
Zurück zum Zitat Banerjee D, Reddy KR. Review article: safety and tolerability of direct-acting anti-viral agents in the new era of hepatitis C therapy. Aliment Pharmacol Ther 2016;43:674–696CrossRefPubMed Banerjee D, Reddy KR. Review article: safety and tolerability of direct-acting anti-viral agents in the new era of hepatitis C therapy. Aliment Pharmacol Ther 2016;43:674–696CrossRefPubMed
8.
Zurück zum Zitat Jacobson IM, Lawitz E, Kwo PY, et al. Safety and efficacy of elbasvir/grazoprevir in patients with hepatitis C virus infection and compensated cirrhosis: an integrated analysis. Gastroenterology 2017;152(1372–82): e2 Jacobson IM, Lawitz E, Kwo PY, et al. Safety and efficacy of elbasvir/grazoprevir in patients with hepatitis C virus infection and compensated cirrhosis: an integrated analysis. Gastroenterology 2017;152(1372–82): e2
9.
Zurück zum Zitat Forns X, Lee SS, Valdes J, et al. Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infections in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial. Lancet Infect Dis 2017;17:1062–1068CrossRefPubMed Forns X, Lee SS, Valdes J, et al. Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infections in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial. Lancet Infect Dis 2017;17:1062–1068CrossRefPubMed
10.
Zurück zum Zitat Gane E, Poordad F, Zadeikis N, et al. Safety and pharmacokinetics of glecaprevir/pibrentasvir in adults with chronic genotype 1–6 hepatitis C virus infections and compensated liver disease. Clin Infect Dis 2019;69(10):1657–1664CrossRefPubMedPubMedCentral Gane E, Poordad F, Zadeikis N, et al. Safety and pharmacokinetics of glecaprevir/pibrentasvir in adults with chronic genotype 1–6 hepatitis C virus infections and compensated liver disease. Clin Infect Dis 2019;69(10):1657–1664CrossRefPubMedPubMedCentral
11.
Zurück zum Zitat Maan R, van Tilborg M, Deterding K, et al. Safety and effectiveness of direct-acting antiviral agents for treatment of patients with chronic hepatitis C Virus infection and cirrhosis. Clin Gastroenterol Hepatol 2016;14(12):1821-1830.e6CrossRefPubMed Maan R, van Tilborg M, Deterding K, et al. Safety and effectiveness of direct-acting antiviral agents for treatment of patients with chronic hepatitis C Virus infection and cirrhosis. Clin Gastroenterol Hepatol 2016;14(12):1821-1830.e6CrossRefPubMed
19.
Zurück zum Zitat Hosmer DW, Hosmer T, Le Cessie S, Lemeshow S. A comparison of goodness-of-ft. tests for the logistic regression model. Stat Med 1997;16:965–980CrossRefPubMed Hosmer DW, Hosmer T, Le Cessie S, Lemeshow S. A comparison of goodness-of-ft. tests for the logistic regression model. Stat Med 1997;16:965–980CrossRefPubMed
20.
Zurück zum Zitat D’Amico G, Morabito A, D’Amico M, Pasta L, Malizia G, Rebora P, et al. Clinical states of cirrhosis and competing risks. J Hepatol 2018;68(3):563–576CrossRefPubMed D’Amico G, Morabito A, D’Amico M, Pasta L, Malizia G, Rebora P, et al. Clinical states of cirrhosis and competing risks. J Hepatol 2018;68(3):563–576CrossRefPubMed
21.
Zurück zum Zitat Curry MP, Oleary JG, Bzowej N, Muir AJ, Korenblat KM, Fenkel JM, et al. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. N Engl J Med 2015;373(27):2618–2628CrossRefPubMed Curry MP, Oleary JG, Bzowej N, Muir AJ, Korenblat KM, Fenkel JM, et al. Sofosbuvir and velpatasvir for HCV in patients with decompensated cirrhosis. N Engl J Med 2015;373(27):2618–2628CrossRefPubMed
22.
Zurück zum Zitat Welzel TM, Petersen J, Herzer K, Ferenci P, Gschwantler M, Wedemeyer H, et al. Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort. Gut 2016;65(11):1861–1870CrossRefPubMed Welzel TM, Petersen J, Herzer K, Ferenci P, Gschwantler M, Wedemeyer H, et al. Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort. Gut 2016;65(11):1861–1870CrossRefPubMed
Metadaten
Titel
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
Publikationsdatum
05.06.2023
Verlag
Springer India
Erschienen in
Hepatology International / Ausgabe 5/2023
Print ISSN: 1936-0533
Elektronische ISSN: 1936-0541
DOI
https://doi.org/10.1007/s12072-023-10547-4

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