Daclatasvir and asunaprevir in hemodialysis patients with hepatitis C virus infection: a nationwide retrospective study in Japan

Background Hepatitis C virus (HCV) infection is common in hemodialysis patients and worsens their prognosis, while antiviral therapy options are limited. Recently, clinical trial and real-world, small-scale studies have reported excellent responses to direct-acting antivirals in patients with advanc...

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Published inJournal of gastroenterology Vol. 53; no. 1; pp. 119 - 128
Main Authors Suda, Goki, Furusyo, Norihiro, Toyoda, Hidenori, Kawakami, Yoshiiku, Ikeda, Hiroki, Suzuki, Michihiro, Arataki, Keiko, Mori, Nami, Tsuji, Keiji, Katamura, Yoshio, Takaguchi, Koichi, Ishikawa, Toru, Tsuji, Kunihiko, Shimada, Noritomo, Hiraoka, Atsushi, Yamsaki, Sho, Nakai, Masato, Sho, Takuya, Morikawa, Kenichi, Ogawa, Koji, Kudo, Mineo, Nagasaka, Atsushi, Furuya, Ken, Yamamoto, Yoshiya, Kato, Kanji, Ueno, Yoshiyuki, Iio, Etsuko, Tanaka, Yasuhito, Kurosaki, Masayuki, Kumada, Takashi, Chayama, Kazuaki, Sakamoto, Naoya
Format Journal Article
LanguageEnglish
Published Tokyo Springer Japan 01.01.2018
Springer Nature B.V
Subjects
Abdominal Surgery
Adult
Aged
Aged, 80 and over
Alanine
Alanine transaminase
Antiviral agents
Antiviral Agents - administration & dosage
Antiviral Agents - adverse effects
Antiviral Agents - pharmacology
Antiviral drugs
Biliary Tract
Clinical trials
Colorectal Surgery
Data processing
Drug Therapy, Combination
Exanthema
Female
Fibrosis
Gastroenterology
Genotype
Genotype & phenotype
Hemodialysis
Hepacivirus - genetics
Hepatitis
Hepatitis C
Hepatitis C, Chronic - drug therapy
Hepatitis C, Chronic - virology
Hepatocellular carcinoma
Hepatology
Humans
Imidazoles - administration & dosage
Imidazoles - adverse effects
Imidazoles - pharmacology
Infections
Isoquinolines - administration & dosage
Isoquinolines - adverse effects
Isoquinolines - pharmacology
Japan
Kidney transplantation
Liver
Liver cancer
Male
Medicine
Medicine & Public Health
Middle Aged
Original Article—Liver
Pancreas
Renal Dialysis
Retrospective Studies
Sulfonamides - administration & dosage
Sulfonamides - adverse effects
Sulfonamides - pharmacology
Surgical Oncology
Sustained Virologic Response
Transaminase
Treatment Outcome
UMIN
UMIN000024227
Japan
DAAs
HCV
Hemodialysis
CKD
Online AccessGet full text

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Abstract Background Hepatitis C virus (HCV) infection is common in hemodialysis patients and worsens their prognosis, while antiviral therapy options are limited. Recently, clinical trial and real-world, small-scale studies have reported excellent responses to direct-acting antivirals in patients with advanced chronic kidney diseases. However, real-world, large-scale data were lacking. This large multicenter analysis included HCV-infected hemodialysis patients receiving combination therapy with a nonstructural protein 5A (NS5A) inhibitor, daclatasvir (DCV), and a protease inhibitor, asunaprevir (ASV). Methods Twenty-three centers in Japan participated in this study of 123 hemodialysis patients with genotype 1 HCV infection, who received DCV/ASV combination therapy between November 2014 and March 2016. We collected and analyzed data relating to treatment outcome, baseline clinical information, laboratory measurements (during and after the treatment), and adverse events. Results Thirty-nine patients (31.7%) had advanced liver fibrosis, 12 (9.8%) had histories of hepatocellular carcinoma (HCC), and 18 (14.6%) had baseline resistance-associated variants (RAVs) of NS5A. The overall sustained virological response (SVR)12 rate was 95.9% (118/123). Notably, all patients with HCC and 94.4% (17/18) of those with NS5A RAVs achieved SVR12. Significant factors associated with non-SVR were advanced fibrosis and the interleukin-28B non-TT genotype at rs8099917. Four patients (3.3%) discontinued therapy because of adverse events including elevated serum alanine transaminase levels ( n  = 2), rash ( n  = 1), and HCC ( n  = 1); all of these achieved SVR12. Conclusions This real-world, nationwide study revealed that DCV/ASV combination therapy was safe and highly effective for hemodialysis patients with genotype 1 HCV infections. This study was registered at the UMIN Clinical Trials Registry (UMIN000024227).
AbstractList BackgroundHepatitis C virus (HCV) infection is common in hemodialysis patients and worsens their prognosis, while antiviral therapy options are limited. Recently, clinical trial and real-world, small-scale studies have reported excellent responses to direct-acting antivirals in patients with advanced chronic kidney diseases. However, real-world, large-scale data were lacking. This large multicenter analysis included HCV-infected hemodialysis patients receiving combination therapy with a nonstructural protein 5A (NS5A) inhibitor, daclatasvir (DCV), and a protease inhibitor, asunaprevir (ASV).MethodsTwenty-three centers in Japan participated in this study of 123 hemodialysis patients with genotype 1 HCV infection, who received DCV/ASV combination therapy between November 2014 and March 2016. We collected and analyzed data relating to treatment outcome, baseline clinical information, laboratory measurements (during and after the treatment), and adverse events.ResultsThirty-nine patients (31.7%) had advanced liver fibrosis, 12 (9.8%) had histories of hepatocellular carcinoma (HCC), and 18 (14.6%) had baseline resistance-associated variants (RAVs) of NS5A. The overall sustained virological response (SVR)12 rate was 95.9% (118/123). Notably, all patients with HCC and 94.4% (17/18) of those with NS5A RAVs achieved SVR12. Significant factors associated with non-SVR were advanced fibrosis and the interleukin-28B non-TT genotype at rs8099917. Four patients (3.3%) discontinued therapy because of adverse events including elevated serum alanine transaminase levels (n = 2), rash (n = 1), and HCC (n = 1); all of these achieved SVR12.ConclusionsThis real-world, nationwide study revealed that DCV/ASV combination therapy was safe and highly effective for hemodialysis patients with genotype 1 HCV infections. This study was registered at the UMIN Clinical Trials Registry (UMIN000024227).
Background Hepatitis C virus (HCV) infection is common in hemodialysis patients and worsens their prognosis, while antiviral therapy options are limited. Recently, clinical trial and real-world, small-scale studies have reported excellent responses to direct-acting antivirals in patients with advanced chronic kidney diseases. However, real-world, large-scale data were lacking. This large multicenter analysis included HCV-infected hemodialysis patients receiving combination therapy with a nonstructural protein 5A (NS5A) inhibitor, daclatasvir (DCV), and a protease inhibitor, asunaprevir (ASV). Methods Twenty-three centers in Japan participated in this study of 123 hemodialysis patients with genotype 1 HCV infection, who received DCV/ASV combination therapy between November 2014 and March 2016. We collected and analyzed data relating to treatment outcome, baseline clinical information, laboratory measurements (during and after the treatment), and adverse events. Results Thirty-nine patients (31.7%) had advanced liver fibrosis, 12 (9.8%) had histories of hepatocellular carcinoma (HCC), and 18 (14.6%) had baseline resistance-associated variants (RAVs) of NS5A. The overall sustained virological response (SVR)12 rate was 95.9% (118/123). Notably, all patients with HCC and 94.4% (17/18) of those with NS5A RAVs achieved SVR12. Significant factors associated with non-SVR were advanced fibrosis and the interleukin-28B non-TT genotype at rs8099917. Four patients (3.3%) discontinued therapy because of adverse events including elevated serum alanine transaminase levels ( n  = 2), rash ( n  = 1), and HCC ( n  = 1); all of these achieved SVR12. Conclusions This real-world, nationwide study revealed that DCV/ASV combination therapy was safe and highly effective for hemodialysis patients with genotype 1 HCV infections. This study was registered at the UMIN Clinical Trials Registry (UMIN000024227).
Hepatitis C virus (HCV) infection is common in hemodialysis patients and worsens their prognosis, while antiviral therapy options are limited. Recently, clinical trial and real-world, small-scale studies have reported excellent responses to direct-acting antivirals in patients with advanced chronic kidney diseases. However, real-world, large-scale data were lacking. This large multicenter analysis included HCV-infected hemodialysis patients receiving combination therapy with a nonstructural protein 5A (NS5A) inhibitor, daclatasvir (DCV), and a protease inhibitor, asunaprevir (ASV).BACKGROUNDHepatitis C virus (HCV) infection is common in hemodialysis patients and worsens their prognosis, while antiviral therapy options are limited. Recently, clinical trial and real-world, small-scale studies have reported excellent responses to direct-acting antivirals in patients with advanced chronic kidney diseases. However, real-world, large-scale data were lacking. This large multicenter analysis included HCV-infected hemodialysis patients receiving combination therapy with a nonstructural protein 5A (NS5A) inhibitor, daclatasvir (DCV), and a protease inhibitor, asunaprevir (ASV).Twenty-three centers in Japan participated in this study of 123 hemodialysis patients with genotype 1 HCV infection, who received DCV/ASV combination therapy between November 2014 and March 2016. We collected and analyzed data relating to treatment outcome, baseline clinical information, laboratory measurements (during and after the treatment), and adverse events.METHODSTwenty-three centers in Japan participated in this study of 123 hemodialysis patients with genotype 1 HCV infection, who received DCV/ASV combination therapy between November 2014 and March 2016. We collected and analyzed data relating to treatment outcome, baseline clinical information, laboratory measurements (during and after the treatment), and adverse events.Thirty-nine patients (31.7%) had advanced liver fibrosis, 12 (9.8%) had histories of hepatocellular carcinoma (HCC), and 18 (14.6%) had baseline resistance-associated variants (RAVs) of NS5A. The overall sustained virological response (SVR)12 rate was 95.9% (118/123). Notably, all patients with HCC and 94.4% (17/18) of those with NS5A RAVs achieved SVR12. Significant factors associated with non-SVR were advanced fibrosis and the interleukin-28B non-TT genotype at rs8099917. Four patients (3.3%) discontinued therapy because of adverse events including elevated serum alanine transaminase levels (n = 2), rash (n = 1), and HCC (n = 1); all of these achieved SVR12.RESULTSThirty-nine patients (31.7%) had advanced liver fibrosis, 12 (9.8%) had histories of hepatocellular carcinoma (HCC), and 18 (14.6%) had baseline resistance-associated variants (RAVs) of NS5A. The overall sustained virological response (SVR)12 rate was 95.9% (118/123). Notably, all patients with HCC and 94.4% (17/18) of those with NS5A RAVs achieved SVR12. Significant factors associated with non-SVR were advanced fibrosis and the interleukin-28B non-TT genotype at rs8099917. Four patients (3.3%) discontinued therapy because of adverse events including elevated serum alanine transaminase levels (n = 2), rash (n = 1), and HCC (n = 1); all of these achieved SVR12.This real-world, nationwide study revealed that DCV/ASV combination therapy was safe and highly effective for hemodialysis patients with genotype 1 HCV infections. This study was registered at the UMIN Clinical Trials Registry (UMIN000024227).CONCLUSIONSThis real-world, nationwide study revealed that DCV/ASV combination therapy was safe and highly effective for hemodialysis patients with genotype 1 HCV infections. This study was registered at the UMIN Clinical Trials Registry (UMIN000024227).
Hepatitis C virus (HCV) infection is common in hemodialysis patients and worsens their prognosis, while antiviral therapy options are limited. Recently, clinical trial and real-world, small-scale studies have reported excellent responses to direct-acting antivirals in patients with advanced chronic kidney diseases. However, real-world, large-scale data were lacking. This large multicenter analysis included HCV-infected hemodialysis patients receiving combination therapy with a nonstructural protein 5A (NS5A) inhibitor, daclatasvir (DCV), and a protease inhibitor, asunaprevir (ASV). Twenty-three centers in Japan participated in this study of 123 hemodialysis patients with genotype 1 HCV infection, who received DCV/ASV combination therapy between November 2014 and March 2016. We collected and analyzed data relating to treatment outcome, baseline clinical information, laboratory measurements (during and after the treatment), and adverse events. Thirty-nine patients (31.7%) had advanced liver fibrosis, 12 (9.8%) had histories of hepatocellular carcinoma (HCC), and 18 (14.6%) had baseline resistance-associated variants (RAVs) of NS5A. The overall sustained virological response (SVR)12 rate was 95.9% (118/123). Notably, all patients with HCC and 94.4% (17/18) of those with NS5A RAVs achieved SVR12. Significant factors associated with non-SVR were advanced fibrosis and the interleukin-28B non-TT genotype at rs8099917. Four patients (3.3%) discontinued therapy because of adverse events including elevated serum alanine transaminase levels (n = 2), rash (n = 1), and HCC (n = 1); all of these achieved SVR12. This real-world, nationwide study revealed that DCV/ASV combination therapy was safe and highly effective for hemodialysis patients with genotype 1 HCV infections. This study was registered at the UMIN Clinical Trials Registry (UMIN000024227).
Author Takaguchi, Koichi
Suzuki, Michihiro
Kato, Kanji
Sakamoto, Naoya
Morikawa, Kenichi
Sho, Takuya
Ueno, Yoshiyuki
Furuya, Ken
Shimada, Noritomo
Ikeda, Hiroki
Suda, Goki
Ogawa, Koji
Kurosaki, Masayuki
Tsuji, Keiji
Katamura, Yoshio
Arataki, Keiko
Ishikawa, Toru
Furusyo, Norihiro
Mori, Nami
Hiraoka, Atsushi
Yamamoto, Yoshiya
Iio, Etsuko
Nagasaka, Atsushi
Toyoda, Hidenori
Nakai, Masato
Kumada, Takashi
Yamsaki, Sho
Tsuji, Kunihiko
Kudo, Mineo
Chayama, Kazuaki
Tanaka, Yasuhito
Kawakami, Yoshiiku
Author_xml – sequence: 1
  givenname: Goki
  surname: Suda
  fullname: Suda, Goki
  organization: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University
– sequence: 2
  givenname: Norihiro
  surname: Furusyo
  fullname: Furusyo, Norihiro
  organization: Department of General Internal Medicine, Kyushu University Hospital
– sequence: 3
  givenname: Hidenori
  surname: Toyoda
  fullname: Toyoda, Hidenori
  organization: Department of Gastroenterology, Ogaki Municipal Hospital
– sequence: 4
  givenname: Yoshiiku
  surname: Kawakami
  fullname: Kawakami, Yoshiiku
  organization: Department of Gastroenterology and Metabolism, Applied Life Science, Institute of Biomedical and Health Science, Hiroshima University
– sequence: 5
  givenname: Hiroki
  surname: Ikeda
  fullname: Ikeda, Hiroki
  organization: Division of Gastroenterology and Hepatology, St. Marianna University School of Medicine
– sequence: 6
  givenname: Michihiro
  surname: Suzuki
  fullname: Suzuki, Michihiro
  organization: Division of Gastroenterology and Hepatology, St. Marianna University School of Medicine
– sequence: 7
  givenname: Keiko
  surname: Arataki
  fullname: Arataki, Keiko
  organization: Tsuchiya General Hospital
– sequence: 8
  givenname: Nami
  surname: Mori
  fullname: Mori, Nami
  organization: Department of Gastroenterology/Liver Center, Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital
– sequence: 9
  givenname: Keiji
  surname: Tsuji
  fullname: Tsuji, Keiji
  organization: Department of Gastroenterology/Liver Center, Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital
– sequence: 10
  givenname: Yoshio
  surname: Katamura
  fullname: Katamura, Yoshio
  organization: Department of Gastroenterology, Onomichi General Hospital
– sequence: 11
  givenname: Koichi
  surname: Takaguchi
  fullname: Takaguchi, Koichi
  organization: Department of Hepatology, Kagawa Prefectural Central Hospital
– sequence: 12
  givenname: Toru
  surname: Ishikawa
  fullname: Ishikawa, Toru
  organization: Department of Gastroenterology and Hepatology, Saiseikai Niigata Daini Hospital
– sequence: 13
  givenname: Kunihiko
  surname: Tsuji
  fullname: Tsuji, Kunihiko
  organization: Center for Gastroenterology, Teine Keijinkai Hospital
– sequence: 14
  givenname: Noritomo
  surname: Shimada
  fullname: Shimada, Noritomo
  organization: Division of Gastroenterology and Hepatology, Ootakanomori Hospital
– sequence: 15
  givenname: Atsushi
  surname: Hiraoka
  fullname: Hiraoka, Atsushi
  organization: Gastroenterology Center, Ehime Prefectural Central Hospital
– sequence: 16
  givenname: Sho
  surname: Yamsaki
  fullname: Yamsaki, Sho
  organization: Department of General Internal Medicine, Kyushu University Hospital
– sequence: 17
  givenname: Masato
  surname: Nakai
  fullname: Nakai, Masato
  organization: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University
– sequence: 18
  givenname: Takuya
  surname: Sho
  fullname: Sho, Takuya
  organization: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University
– sequence: 19
  givenname: Kenichi
  surname: Morikawa
  fullname: Morikawa, Kenichi
  organization: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University
– sequence: 20
  givenname: Koji
  surname: Ogawa
  fullname: Ogawa, Koji
  organization: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University
– sequence: 21
  givenname: Mineo
  surname: Kudo
  fullname: Kudo, Mineo
  organization: Sapporo Hokuyu Hospital
– sequence: 22
  givenname: Atsushi
  surname: Nagasaka
  fullname: Nagasaka, Atsushi
  organization: Sapporo City General Hospital
– sequence: 23
  givenname: Ken
  surname: Furuya
  fullname: Furuya, Ken
  organization: Department of Gastroenterology and Hepatology, Japan Community Health Care Organization (JCHO) Hokkaido Hospital
– sequence: 24
  givenname: Yoshiya
  surname: Yamamoto
  fullname: Yamamoto, Yoshiya
  organization: Hakodate City Hospital
– sequence: 25
  givenname: Kanji
  surname: Kato
  fullname: Kato, Kanji
  organization: Iwamisawa Manicipal General Hospital
– sequence: 26
  givenname: Yoshiyuki
  surname: Ueno
  fullname: Ueno, Yoshiyuki
  organization: Department of Gastroenterology, Faculty of Medicine, Yamagata University
– sequence: 27
  givenname: Etsuko
  surname: Iio
  fullname: Iio, Etsuko
  organization: Nagoya City University Graduate School of Medical Sciences
– sequence: 28
  givenname: Yasuhito
  surname: Tanaka
  fullname: Tanaka, Yasuhito
  organization: Nagoya City University Graduate School of Medical Sciences
– sequence: 29
  givenname: Masayuki
  surname: Kurosaki
  fullname: Kurosaki, Masayuki
  organization: Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital
– sequence: 30
  givenname: Takashi
  surname: Kumada
  fullname: Kumada, Takashi
  organization: Department of Gastroenterology, Ogaki Municipal Hospital
– sequence: 31
  givenname: Kazuaki
  surname: Chayama
  fullname: Chayama, Kazuaki
  organization: Department of Gastroenterology and Metabolism, Applied Life Science, Institute of Biomedical and Health Science, Hiroshima University
– sequence: 32
  givenname: Naoya
  surname: Sakamoto
  fullname: Sakamoto, Naoya
  email: sakamoto@med.hokudai.ac.jp
  organization: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University
BackLink https://www.ncbi.nlm.nih.gov/pubmed/28560477$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
Copyright Japanese Society of Gastroenterology 2017
Journal of Gastroenterology is a copyright of Springer, (2017). All Rights Reserved.
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Keywords DAAs
HCV
Hemodialysis
CKD
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Snippet Background Hepatitis C virus (HCV) infection is common in hemodialysis patients and worsens their prognosis, while antiviral therapy options are limited....
Hepatitis C virus (HCV) infection is common in hemodialysis patients and worsens their prognosis, while antiviral therapy options are limited. Recently,...
BackgroundHepatitis C virus (HCV) infection is common in hemodialysis patients and worsens their prognosis, while antiviral therapy options are limited....
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StartPage 119
SubjectTerms Abdominal Surgery
Adult
Aged
Aged, 80 and over
Alanine
Alanine transaminase
Antiviral agents
Antiviral Agents - administration & dosage
Antiviral Agents - adverse effects
Antiviral Agents - pharmacology
Antiviral drugs
Biliary Tract
Clinical trials
Colorectal Surgery
Data processing
Drug Therapy, Combination
Exanthema
Female
Fibrosis
Gastroenterology
Genotype
Genotype & phenotype
Hemodialysis
Hepacivirus - genetics
Hepatitis
Hepatitis C
Hepatitis C, Chronic - drug therapy
Hepatitis C, Chronic - virology
Hepatocellular carcinoma
Hepatology
Humans
Imidazoles - administration & dosage
Imidazoles - adverse effects
Imidazoles - pharmacology
Infections
Isoquinolines - administration & dosage
Isoquinolines - adverse effects
Isoquinolines - pharmacology
Japan
Kidney transplantation
Liver
Liver cancer
Male
Medicine
Medicine & Public Health
Middle Aged
Original Article—Liver
Pancreas
Renal Dialysis
Retrospective Studies
Sulfonamides - administration & dosage
Sulfonamides - adverse effects
Sulfonamides - pharmacology
Surgical Oncology
Sustained Virologic Response
Transaminase
Treatment Outcome
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Title Daclatasvir and asunaprevir in hemodialysis patients with hepatitis C virus infection: a nationwide retrospective study in Japan
URI https://link.springer.com/article/10.1007/s00535-017-1353-y
https://www.ncbi.nlm.nih.gov/pubmed/28560477
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