Glecaprevir and pibrentasvir for Japanese patients with chronic hepatitis C genotype 1 or 2 infection: Results from a multicenter, real-world cohort study

The Kyushu University Liver Disease Study (KULDS) Group

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Aim: Glecaprevir (GLE) and pibrentasvir (PIB) are new direct-acting antiviral agents (DAAs) with pangenotypic inhibitors that respectively target the hepatitis C virus (HCV) NS3/4 protease and NS5A. The aim of this study was to evaluate the effectiveness and safety of combining GLE and PIB for patients with HCV genotype (GT) 1 or 2 infection in the clinical setting, including patients DAA-experienced or on hemodialysis. Methods: This multicenter, real-world, retrospective, cohort study consisted of 314 Japanese patients who were treated with GLE (300 mg) and PIB (120 mg) for a fixed 8- or 12-week duration. We evaluated the sustained virologic response rate 12 weeks after the end of treatment (SVR12) and adverse events. Results: Among the treated patients, 122 had GT1 and 192 GT2 infection. The overall SVR12 rates in the per-protocol populations were 99.2% (119/120) for GT1 and 98.9% (183/185) for GT2. High SVR12 rates were observed in almost all subgroups, including cirrhosis, receiving hemodialysis, or previous all-oral DAA groups treated with asunaprevir and daclatasvir (GT1b), ledipasvir/sofosbuvir (GT1), or sofosbuvir and ribavirin (GT2). Virological relapse occurred in only 1.0% (3/305) of the patients who completed treatment. The most common adverse events were pruritus and fatigue (>5% of patients). Serious adverse events were rare and discontinuation due to an adverse event was required for 1.6% of the patients. Conclusions: In this real-world cohort study, treatment with GLE/PIB achieved high SVR12 rates with a low rate of serious adverse events among patients with HCV GT1 or 2 infection.

Original languageEnglish
Pages (from-to)617-626
Number of pages10
JournalHepatology Research
Volume49
Issue number6
DOIs
Publication statusPublished - Jun 1 2019

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Chronic Hepatitis C
Cohort Studies
Genotype
Infection
Antiviral Agents
Hepacivirus
Renal Dialysis
Ribavirin
Pruritus
Fatigue
Fibrosis
Therapeutics
Retrospective Studies
Safety
Recurrence
Population

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Infectious Diseases

Cite this

Glecaprevir and pibrentasvir for Japanese patients with chronic hepatitis C genotype 1 or 2 infection : Results from a multicenter, real-world cohort study. / The Kyushu University Liver Disease Study (KULDS) Group.

In: Hepatology Research, Vol. 49, No. 6, 01.06.2019, p. 617-626.

Research output: Contribution to journalArticle

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abstract = "Aim: Glecaprevir (GLE) and pibrentasvir (PIB) are new direct-acting antiviral agents (DAAs) with pangenotypic inhibitors that respectively target the hepatitis C virus (HCV) NS3/4 protease and NS5A. The aim of this study was to evaluate the effectiveness and safety of combining GLE and PIB for patients with HCV genotype (GT) 1 or 2 infection in the clinical setting, including patients DAA-experienced or on hemodialysis. Methods: This multicenter, real-world, retrospective, cohort study consisted of 314 Japanese patients who were treated with GLE (300 mg) and PIB (120 mg) for a fixed 8- or 12-week duration. We evaluated the sustained virologic response rate 12 weeks after the end of treatment (SVR12) and adverse events. Results: Among the treated patients, 122 had GT1 and 192 GT2 infection. The overall SVR12 rates in the per-protocol populations were 99.2{\%} (119/120) for GT1 and 98.9{\%} (183/185) for GT2. High SVR12 rates were observed in almost all subgroups, including cirrhosis, receiving hemodialysis, or previous all-oral DAA groups treated with asunaprevir and daclatasvir (GT1b), ledipasvir/sofosbuvir (GT1), or sofosbuvir and ribavirin (GT2). Virological relapse occurred in only 1.0{\%} (3/305) of the patients who completed treatment. The most common adverse events were pruritus and fatigue (>5{\%} of patients). Serious adverse events were rare and discontinuation due to an adverse event was required for 1.6{\%} of the patients. Conclusions: In this real-world cohort study, treatment with GLE/PIB achieved high SVR12 rates with a low rate of serious adverse events among patients with HCV GT1 or 2 infection.",
author = "{The Kyushu University Liver Disease Study (KULDS) Group} and Eiichi Ogawa and Norihiro Furusyo and Makoto Nakamuta and Hideyuki Nomura and Norihiro Furusyo and Kazuhiro Takahashi and Toshimasa Koyanagi and Eiji Kajiwara and Kazufumi Dohmen and Akira Kawano and Aritsune Ooho and Koichi Azuma and Masaki Kato and Shinji Shimoda and Jun Hayashi",
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T1 - Glecaprevir and pibrentasvir for Japanese patients with chronic hepatitis C genotype 1 or 2 infection

T2 - Results from a multicenter, real-world cohort study

AU - The Kyushu University Liver Disease Study (KULDS) Group

AU - Ogawa, Eiichi

AU - Furusyo, Norihiro

AU - Nakamuta, Makoto

AU - Nomura, Hideyuki

AU - Furusyo, Norihiro

AU - Takahashi, Kazuhiro

AU - Koyanagi, Toshimasa

AU - Kajiwara, Eiji

AU - Dohmen, Kazufumi

AU - Kawano, Akira

AU - Ooho, Aritsune

AU - Azuma, Koichi

AU - Kato, Masaki

AU - Shimoda, Shinji

AU - Hayashi, Jun

PY - 2019/6/1

Y1 - 2019/6/1

N2 - Aim: Glecaprevir (GLE) and pibrentasvir (PIB) are new direct-acting antiviral agents (DAAs) with pangenotypic inhibitors that respectively target the hepatitis C virus (HCV) NS3/4 protease and NS5A. The aim of this study was to evaluate the effectiveness and safety of combining GLE and PIB for patients with HCV genotype (GT) 1 or 2 infection in the clinical setting, including patients DAA-experienced or on hemodialysis. Methods: This multicenter, real-world, retrospective, cohort study consisted of 314 Japanese patients who were treated with GLE (300 mg) and PIB (120 mg) for a fixed 8- or 12-week duration. We evaluated the sustained virologic response rate 12 weeks after the end of treatment (SVR12) and adverse events. Results: Among the treated patients, 122 had GT1 and 192 GT2 infection. The overall SVR12 rates in the per-protocol populations were 99.2% (119/120) for GT1 and 98.9% (183/185) for GT2. High SVR12 rates were observed in almost all subgroups, including cirrhosis, receiving hemodialysis, or previous all-oral DAA groups treated with asunaprevir and daclatasvir (GT1b), ledipasvir/sofosbuvir (GT1), or sofosbuvir and ribavirin (GT2). Virological relapse occurred in only 1.0% (3/305) of the patients who completed treatment. The most common adverse events were pruritus and fatigue (>5% of patients). Serious adverse events were rare and discontinuation due to an adverse event was required for 1.6% of the patients. Conclusions: In this real-world cohort study, treatment with GLE/PIB achieved high SVR12 rates with a low rate of serious adverse events among patients with HCV GT1 or 2 infection.

AB - Aim: Glecaprevir (GLE) and pibrentasvir (PIB) are new direct-acting antiviral agents (DAAs) with pangenotypic inhibitors that respectively target the hepatitis C virus (HCV) NS3/4 protease and NS5A. The aim of this study was to evaluate the effectiveness and safety of combining GLE and PIB for patients with HCV genotype (GT) 1 or 2 infection in the clinical setting, including patients DAA-experienced or on hemodialysis. Methods: This multicenter, real-world, retrospective, cohort study consisted of 314 Japanese patients who were treated with GLE (300 mg) and PIB (120 mg) for a fixed 8- or 12-week duration. We evaluated the sustained virologic response rate 12 weeks after the end of treatment (SVR12) and adverse events. Results: Among the treated patients, 122 had GT1 and 192 GT2 infection. The overall SVR12 rates in the per-protocol populations were 99.2% (119/120) for GT1 and 98.9% (183/185) for GT2. High SVR12 rates were observed in almost all subgroups, including cirrhosis, receiving hemodialysis, or previous all-oral DAA groups treated with asunaprevir and daclatasvir (GT1b), ledipasvir/sofosbuvir (GT1), or sofosbuvir and ribavirin (GT2). Virological relapse occurred in only 1.0% (3/305) of the patients who completed treatment. The most common adverse events were pruritus and fatigue (>5% of patients). Serious adverse events were rare and discontinuation due to an adverse event was required for 1.6% of the patients. Conclusions: In this real-world cohort study, treatment with GLE/PIB achieved high SVR12 rates with a low rate of serious adverse events among patients with HCV GT1 or 2 infection.

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