Long-term changes in hepatic reserve and prognosis after direct-acting antiviral treatment in patients with hepatitis C virus-related decompensated cirrhosis: a five-year follow-up study of a Japanese phase 3 trial

Tahata, Yuki; Hikita, Hayato; Takaki, Akinobu; Kurosaki, Masayuki; Matsuura, Kentaro; Yatsuhashi, Hiroshi; Kuroda, Hidekatsu; Ueno, Yoshiyuki; Maekawa, Shinya; Nakamura, Masato; Sakamori, Ryotaro; Kodama, Takahiro; Takehara, Tetsuo

doi:https://doi.org/10.1007/s00535-025-02312-1

Long-term changes in hepatic reserve and prognosis after direct-acting antiviral treatment in patients with hepatitis C virus-related decompensated cirrhosis: a five-year follow-up study of a Japanese phase 3 trial

Tahata, Yuki; Hikita, Hayato; Takaki, Akinobu et al.

Journal of Gastroenterology, 2025

Number of Access:13（2025-12-05 11:18 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/103021

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Title	Long-term changes in hepatic reserve and prognosis after direct-acting antiviral treatment in patients with hepatitis C virus-related decompensated cirrhosis: a five-year follow-up study of a Japanese phase 3 trial
Creator	NRID 1000000838047 1000000838047 ORCID 0000-0002-9116-7054 0000-0002-9116-7054 researchmap permalink yuki.tahata yuki.tahata Scopus Author ID 56755390400 56755390400 CreatorName Tahata, Yuki
	NRID 1000020623044 1000020623044 ORCID 0000-0003-2488-7315 0000-0003-2488-7315 researchmap permalink hikitahayato hikitahayato Scopus Author ID 23667454900 23667454900 CreatorName Hikita, Hayato
	NRID 1000080359885 1000080359885 CreatorName Takaki, Akinobu
	NRID 1000010280976 1000010280976 CreatorName Kurosaki, Masayuki
	NRID 1000030580576 1000030580576 CreatorName Matsuura, Kentaro
	NRID 1000050360855 1000050360855 CreatorName Yatsuhashi, Hiroshi
	NRID 1000070382596 1000070382596 CreatorName Kuroda, Hidekatsu
	NRID 1000070282126 1000070282126 CreatorName Ueno, Yoshiyuki
	NRID 1000070397298 1000070397298 CreatorName Maekawa, Shinya
	NRID 1000010756703 1000010756703 CreatorName Nakamura, Masato
	NRID 1000010644685 1000010644685 CreatorName Sakamori, Ryotaro
	NRID 1000010623275 1000010623275 ORCID 0000-0002-6250-1324 0000-0002-6250-1324 researchmap permalink takahirokodama takahirokodama Scopus Author ID 35193885800 35193885800 CreatorName Kodama, Takahiro
	NRID 1000070335355 1000070335355 CreatorName Takehara, Tetsuo
Subject	Child–Pugh score
	HCV
	Sofosbuvir
	Survival
	Velpatasvir
Description	Tahata Y., Hikita H., Takaki A., et al. Long-term changes in hepatic reserve and prognosis after direct-acting antiviral treatment in patients with hepatitis C virus-related decompensated cirrhosis: a five-year follow-up study of a Japanese phase 3 trial. Journal of Gastroenterology , (2025); https://doi.org/10.1007/s00535-025-02312-1.
Description	This version of the article has been accepted for publication, after peer review (when applicable) and is subject to Springer Nature’s AM terms of use, but is not the Version of Record and does not reflect post-acceptance improvements, or any corrections. The Version of Record is available online at: https://doi.org/10.1007/s00535-025-02312-1
Abstract	Background: Long-term effects of direct-acting antiviral (DAA) on hepatic reserve and prognosis in hepatitis C virus (HCV)-related decompensated cirrhosis remain unclear. Methods: Ninety-four patients from a follow-up study of the Japanese phase 3 trial of DAA treatment for decompensated cirrhosis were included. Results: Twelve, seventy-seven, and ten percent of patients had Child–Pugh class A/B/C, respectively. The sustained virologic response (SVR) rate was 93.6%. The proportion of Child–Pugh A patients was 21% at end of treatment (EOT), and 40%, 42%, 49%, 40% at 24 weeks, 1 year, 3 years, and 5 years after EOT, respectively. A significant breakpoint for Child–Pugh class improvement to A was observed between 24 weeks and 1 year after EOT. The proportions of patients with albumin levels > 3.5 g/dl increased from 11% (baseline) to 39% (5 years after EOT), and significant breakpoint for this improvement was observed between 12 and 24 weeks after EOT. During the 4.8 years from EOT, 19 patients died, and 1 underwent liver transplantation (LT). The five-year LT-free survival rate was 74.7%. Multivariate analysis identified virologic response and Child–Pugh class at 12 weeks after EOT as significant LT-free survival predictors. The four-year LT-free survival rates were 91.5% for SVR patients and 33.3% for virologic failure patients. Conclusions: In HCV-related decompensated cirrhosis, 5 year LT-free survival rate after DAA was 74.7%, and viral clearance and post-treatment Child–Pugh class were associated with long-term prognosis. Child–Pugh class improved until 24 weeks after EOT, but little change was observed thereafter, which was closely associated with albumin levels.
Publisher	Springer
Source Title	Journal of Gastroenterology
Date of Issued	2025-10-30
Language	English
Handle URL	https://hdl.handle.net/11094/103021
PISSN	09441174
eISSN	14355922
Relation.isVersionOf	DOI (Publisher Version) https://doi.org/10.1007/s00535-025-02312-1
Access Rights	embargoed access
CopyRight	© The Authors, under exclusive licence to Japanese Society of Gastroenterology 2025.
CopyRight	The full-text file will be made open to the public on 30 October 2026 in accordance with the publisher's policy.
oaire:version	Accepted Manuscript
Category	学術雑誌論文 Journal Article

Resource Type	journal article
Local Type	Journal Article
DCMI Type	Text
DCTERMS.bibliographicCitation	Journal of Gastroenterology. 2025
DC.title	Long-term changes in hepatic reserve and prognosis after direct-acting antiviral treatment in patients with hepatitis C virus-related decompensated cirrhosis: a five-year follow-up study of a Japanese phase 3 trial
DC.creator	Tahata, Yuki
	Hikita, Hayato
	Takaki, Akinobu
	Kurosaki, Masayuki
	Matsuura, Kentaro
	Yatsuhashi, Hiroshi
	Kuroda, Hidekatsu
	Ueno, Yoshiyuki
	Maekawa, Shinya
	Nakamura, Masato
	Sakamori, Ryotaro
	Kodama, Takahiro
	Takehara, Tetsuo
DC.publisher	Springer
DC.language' scheme='DCTERMS.RFC1766	English
DC.type' scheme='DCTERMS.DCMIType	Text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2025-10-30
DC.identifier	https://doi.org/10.1007/s00535-025-02312-1
DC.subject	Child–Pugh score
	HCV
	Sofosbuvir
	Survival
	Velpatasvir
DC.description	Tahata Y., Hikita H., Takaki A., et al. Long-term changes in hepatic reserve and prognosis after direct-acting antiviral treatment in patients with hepatitis C virus-related decompensated cirrhosis: a five-year follow-up study of a Japanese phase 3 trial. Journal of Gastroenterology , (2025); https://doi.org/10.1007/s00535-025-02312-1.
DC.description	This version of the article has been accepted for publication, after peer review (when applicable) and is subject to Springer Nature’s AM terms of use, but is not the Version of Record and does not reflect post-acceptance improvements, or any corrections. The Version of Record is available online at: https://doi.org/10.1007/s00535-025-02312-1
DCTERMS.abstract	Background: Long-term effects of direct-acting antiviral (DAA) on hepatic reserve and prognosis in hepatitis C virus (HCV)-related decompensated cirrhosis remain unclear. Methods: Ninety-four patients from a follow-up study of the Japanese phase 3 trial of DAA treatment for decompensated cirrhosis were included. Results: Twelve, seventy-seven, and ten percent of patients had Child–Pugh class A/B/C, respectively. The sustained virologic response (SVR) rate was 93.6%. The proportion of Child–Pugh A patients was 21% at end of treatment (EOT), and 40%, 42%, 49%, 40% at 24 weeks, 1 year, 3 years, and 5 years after EOT, respectively. A significant breakpoint for Child–Pugh class improvement to A was observed between 24 weeks and 1 year after EOT. The proportions of patients with albumin levels > 3.5 g/dl increased from 11% (baseline) to 39% (5 years after EOT), and significant breakpoint for this improvement was observed between 12 and 24 weeks after EOT. During the 4.8 years from EOT, 19 patients died, and 1 underwent liver transplantation (LT). The five-year LT-free survival rate was 74.7%. Multivariate analysis identified virologic response and Child–Pugh class at 12 weeks after EOT as significant LT-free survival predictors. The four-year LT-free survival rates were 91.5% for SVR patients and 33.3% for virologic failure patients. Conclusions: In HCV-related decompensated cirrhosis, 5 year LT-free survival rate after DAA was 74.7%, and viral clearance and post-treatment Child–Pugh class were associated with long-term prognosis. Child–Pugh class improved until 24 weeks after EOT, but little change was observed thereafter, which was closely associated with albumin levels.
DC.rights	© The Authors, under exclusive licence to Japanese Society of Gastroenterology 2025.
DC.rights	The full-text file will be made open to the public on 30 October 2026 in accordance with the publisher's policy.
DC.format	103021
citation_title	Long-term changes in hepatic reserve and prognosis after direct-acting antiviral treatment in patients with hepatitis C virus-related decompensated cirrhosis: a five-year follow-up study of a Japanese phase 3 trial
citation_author	Tahata, Yuki
	Hikita, Hayato
	Takaki, Akinobu
	Kurosaki, Masayuki
	Matsuura, Kentaro
	Yatsuhashi, Hiroshi
	Kuroda, Hidekatsu
	Ueno, Yoshiyuki
	Maekawa, Shinya
	Nakamura, Masato
	Sakamori, Ryotaro
	Kodama, Takahiro
	Takehara, Tetsuo
citation_publisher	Springer
citation_language	English
citation_date	2025-10-30
citation_journal_title	Journal of Gastroenterology
citation_doi	https://doi.org/10.1007/s00535-025-02312-1
citation_public_url	https://hdl.handle.net/11094/103021

Long-term changes in hepatic reserve and prognosis after direct-acting antiviral treatment in patients with hepatitis C virus-related decompensated cirrhosis: a five-year follow-up study of a Japanese phase 3 trial

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