Efficacy and safety of glecaprevir and pibrentasvir treatment for 8 or 12 weeks in patients with recurrent hepatitis C after liver transplantation: a Japanese multicenter experience

Yoshihide Ueda, Tsuyoshi Kobayashi, Toru Ikegami, Satoshi Miuma, Shugo Mizuno, Nobuhisa Akamatsu, Akinobu Takaki, Masatoshi Ishigami, Mitsuhisa Takatsuki, Yasuhiko Sugawara, Yoshihiko Maehara, Shinji Uemoto, Hiroshi Seno

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Abstract

Background: Efficacy of 8-week regimen with direct-acting antivirals (DAA) for patients with hepatitis C after liver transplantation has not been clarified. This study aimed to clarify the efficacy and safety of glecaprevir and pibrentasvir therapy for 8 and 12 weeks in Japanese patients with recurrent hepatitis C after liver transplantation. Methods: A cohort study of liver transplant recipients with recurrent hepatitis C treated with glecaprevir (300 mg/day) and pibrentasvir (120 mg/day) was performed at nine liver transplant centers in Japan. Results: Twenty-five patients with hepatitis C after liver transplantation were treated with glecaprevir and pibrentasvir. Twenty-four patients completed the treatment protocol; treatment was discontinued in one patient who had nausea at 3 days after the initiation of treatment. All the 24 patients who completed the 8- or 12-week treatment protocol achieved a sustained virological response 12 weeks after completion of treatment (SVR12). The SVR12 rates in patients with HCV genotype 1 and 2 were 100% (21 of 21 patients) and 75% (3 of 4 patients), respectively. All patients with prior DAA therapy failure (n = 6), jaundice (n = 4), and liver cirrhosis (n = 4) achieved SVR12. Seven of 8 patients (88%) with severe renal impairment achieved SVR12. Adverse events occurred in 6 of 25 patients (24%), including serious adverse events in 2 patients (8%). Treatment-related adverse events were nausea, pruritus, and mild renal dysfunction. Conclusions: Eight- or 12-week regimen of glecaprevir and pibrentasvir is efficacious and safe in patients with recurrent HCV infection after liver transplantation, even in difficult-to-treat populations, including patients with severe renal impairment, prior DAA experience, liver cirrhosis, or jaundice after liver transplantation.

Original languageEnglish
Pages (from-to)660-666
Number of pages7
JournalJournal of gastroenterology
Volume54
Issue number7
DOIs
Publication statusPublished - Jul 12 2019

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Hepatitis C
Liver Transplantation
Safety
Therapeutics
Antiviral Agents
Clinical Protocols
Jaundice
Kidney
Liver Cirrhosis
Nausea
Liver
Pruritus
Japan
Cohort Studies

All Science Journal Classification (ASJC) codes

  • Gastroenterology

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Efficacy and safety of glecaprevir and pibrentasvir treatment for 8 or 12 weeks in patients with recurrent hepatitis C after liver transplantation : a Japanese multicenter experience. / Ueda, Yoshihide; Kobayashi, Tsuyoshi; Ikegami, Toru; Miuma, Satoshi; Mizuno, Shugo; Akamatsu, Nobuhisa; Takaki, Akinobu; Ishigami, Masatoshi; Takatsuki, Mitsuhisa; Sugawara, Yasuhiko; Maehara, Yoshihiko; Uemoto, Shinji; Seno, Hiroshi.

In: Journal of gastroenterology, Vol. 54, No. 7, 12.07.2019, p. 660-666.

Research output: Contribution to journalArticle

Ueda, Y, Kobayashi, T, Ikegami, T, Miuma, S, Mizuno, S, Akamatsu, N, Takaki, A, Ishigami, M, Takatsuki, M, Sugawara, Y, Maehara, Y, Uemoto, S & Seno, H 2019, 'Efficacy and safety of glecaprevir and pibrentasvir treatment for 8 or 12 weeks in patients with recurrent hepatitis C after liver transplantation: a Japanese multicenter experience', Journal of gastroenterology, vol. 54, no. 7, pp. 660-666. https://doi.org/10.1007/s00535-019-01561-1
Ueda, Yoshihide ; Kobayashi, Tsuyoshi ; Ikegami, Toru ; Miuma, Satoshi ; Mizuno, Shugo ; Akamatsu, Nobuhisa ; Takaki, Akinobu ; Ishigami, Masatoshi ; Takatsuki, Mitsuhisa ; Sugawara, Yasuhiko ; Maehara, Yoshihiko ; Uemoto, Shinji ; Seno, Hiroshi. / Efficacy and safety of glecaprevir and pibrentasvir treatment for 8 or 12 weeks in patients with recurrent hepatitis C after liver transplantation : a Japanese multicenter experience. In: Journal of gastroenterology. 2019 ; Vol. 54, No. 7. pp. 660-666.
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abstract = "Background: Efficacy of 8-week regimen with direct-acting antivirals (DAA) for patients with hepatitis C after liver transplantation has not been clarified. This study aimed to clarify the efficacy and safety of glecaprevir and pibrentasvir therapy for 8 and 12 weeks in Japanese patients with recurrent hepatitis C after liver transplantation. Methods: A cohort study of liver transplant recipients with recurrent hepatitis C treated with glecaprevir (300 mg/day) and pibrentasvir (120 mg/day) was performed at nine liver transplant centers in Japan. Results: Twenty-five patients with hepatitis C after liver transplantation were treated with glecaprevir and pibrentasvir. Twenty-four patients completed the treatment protocol; treatment was discontinued in one patient who had nausea at 3 days after the initiation of treatment. All the 24 patients who completed the 8- or 12-week treatment protocol achieved a sustained virological response 12 weeks after completion of treatment (SVR12). The SVR12 rates in patients with HCV genotype 1 and 2 were 100{\%} (21 of 21 patients) and 75{\%} (3 of 4 patients), respectively. All patients with prior DAA therapy failure (n = 6), jaundice (n = 4), and liver cirrhosis (n = 4) achieved SVR12. Seven of 8 patients (88{\%}) with severe renal impairment achieved SVR12. Adverse events occurred in 6 of 25 patients (24{\%}), including serious adverse events in 2 patients (8{\%}). Treatment-related adverse events were nausea, pruritus, and mild renal dysfunction. Conclusions: Eight- or 12-week regimen of glecaprevir and pibrentasvir is efficacious and safe in patients with recurrent HCV infection after liver transplantation, even in difficult-to-treat populations, including patients with severe renal impairment, prior DAA experience, liver cirrhosis, or jaundice after liver transplantation.",
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T1 - Efficacy and safety of glecaprevir and pibrentasvir treatment for 8 or 12 weeks in patients with recurrent hepatitis C after liver transplantation

T2 - a Japanese multicenter experience

AU - Ueda, Yoshihide

AU - Kobayashi, Tsuyoshi

AU - Ikegami, Toru

AU - Miuma, Satoshi

AU - Mizuno, Shugo

AU - Akamatsu, Nobuhisa

AU - Takaki, Akinobu

AU - Ishigami, Masatoshi

AU - Takatsuki, Mitsuhisa

AU - Sugawara, Yasuhiko

AU - Maehara, Yoshihiko

AU - Uemoto, Shinji

AU - Seno, Hiroshi

PY - 2019/7/12

Y1 - 2019/7/12

N2 - Background: Efficacy of 8-week regimen with direct-acting antivirals (DAA) for patients with hepatitis C after liver transplantation has not been clarified. This study aimed to clarify the efficacy and safety of glecaprevir and pibrentasvir therapy for 8 and 12 weeks in Japanese patients with recurrent hepatitis C after liver transplantation. Methods: A cohort study of liver transplant recipients with recurrent hepatitis C treated with glecaprevir (300 mg/day) and pibrentasvir (120 mg/day) was performed at nine liver transplant centers in Japan. Results: Twenty-five patients with hepatitis C after liver transplantation were treated with glecaprevir and pibrentasvir. Twenty-four patients completed the treatment protocol; treatment was discontinued in one patient who had nausea at 3 days after the initiation of treatment. All the 24 patients who completed the 8- or 12-week treatment protocol achieved a sustained virological response 12 weeks after completion of treatment (SVR12). The SVR12 rates in patients with HCV genotype 1 and 2 were 100% (21 of 21 patients) and 75% (3 of 4 patients), respectively. All patients with prior DAA therapy failure (n = 6), jaundice (n = 4), and liver cirrhosis (n = 4) achieved SVR12. Seven of 8 patients (88%) with severe renal impairment achieved SVR12. Adverse events occurred in 6 of 25 patients (24%), including serious adverse events in 2 patients (8%). Treatment-related adverse events were nausea, pruritus, and mild renal dysfunction. Conclusions: Eight- or 12-week regimen of glecaprevir and pibrentasvir is efficacious and safe in patients with recurrent HCV infection after liver transplantation, even in difficult-to-treat populations, including patients with severe renal impairment, prior DAA experience, liver cirrhosis, or jaundice after liver transplantation.

AB - Background: Efficacy of 8-week regimen with direct-acting antivirals (DAA) for patients with hepatitis C after liver transplantation has not been clarified. This study aimed to clarify the efficacy and safety of glecaprevir and pibrentasvir therapy for 8 and 12 weeks in Japanese patients with recurrent hepatitis C after liver transplantation. Methods: A cohort study of liver transplant recipients with recurrent hepatitis C treated with glecaprevir (300 mg/day) and pibrentasvir (120 mg/day) was performed at nine liver transplant centers in Japan. Results: Twenty-five patients with hepatitis C after liver transplantation were treated with glecaprevir and pibrentasvir. Twenty-four patients completed the treatment protocol; treatment was discontinued in one patient who had nausea at 3 days after the initiation of treatment. All the 24 patients who completed the 8- or 12-week treatment protocol achieved a sustained virological response 12 weeks after completion of treatment (SVR12). The SVR12 rates in patients with HCV genotype 1 and 2 were 100% (21 of 21 patients) and 75% (3 of 4 patients), respectively. All patients with prior DAA therapy failure (n = 6), jaundice (n = 4), and liver cirrhosis (n = 4) achieved SVR12. Seven of 8 patients (88%) with severe renal impairment achieved SVR12. Adverse events occurred in 6 of 25 patients (24%), including serious adverse events in 2 patients (8%). Treatment-related adverse events were nausea, pruritus, and mild renal dysfunction. Conclusions: Eight- or 12-week regimen of glecaprevir and pibrentasvir is efficacious and safe in patients with recurrent HCV infection after liver transplantation, even in difficult-to-treat populations, including patients with severe renal impairment, prior DAA experience, liver cirrhosis, or jaundice after liver transplantation.

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