Treatment with sofosbuvir and ledipasvir without ribavirin for 12 weeks is highly effective for recurrent hepatitis C virus genotype 1b infection after living donor liver transplantation

a Japanese multicenter experience

Yoshihide Ueda, Toru Ikegami, Nobuhisa Akamatsu, Akihiko Soyama, Masahiro Shinoda, Ryoichi Goto, Hideaki Okajima, Tomoharu Yoshizumi, Akinobu Taketomi, Yuukou Kitagawa, Susumu Eguchi, Norihiro Kokudo, Shinji Uemoto, Yoshihiko Maehara

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Background: The optimal therapy for recurrent hepatitis C virus (HCV) infection after liver transplantation has not yet been established. This study aimed to clarify the efficacy and safety of interferon-free therapy with sofosbuvir and ledipasvir without ribavirin for 12 weeks in Japanese patients with HCV genotype 1b infection after living donor liver transplantation. Methods: A cohort study of living donor liver transplant recipients with recurrent HCV genotype 1b infection treated with sofosbuvir (400 mg/day) and ledipasvir (90 mg/day) was performed at six liver transplant centers in Japan. Results: Fifty-four patients were treated with sofosbuvir and ledipasvir. Thirty-eight patients (70%) were treatment experienced, including 17 patients who had undergone prior direct-acting-antiviral-based triple therapy. Ten patients had resistance-associated substitutions at L31 or Y93 in the NS5A region of the HCV genome. Fifty-three patients completed the 12-week treatment protocol; treatment was discontinued in one patient who developed pneumonia at 4 weeks and died thereafter. All 53 patients who completed the treatment regimen achieved a sustained virological response 12 weeks after completion of treatment. Treatment was well tolerated in most patients, but seven patients developed serious adverse events, including hemorrhagic duodenal ulcers (n = 3), infection (n = 2), pleural effusion (n = 1), and alveolar hemorrhage (n = 1). Conclusions: Sofosbuvir and ledipasvir treatment without ribavirin for 12 weeks was highly effective in achieving a sustained virological response in Japanese patients who developed recurrent HCV genotype 1b infection after living donor liver transplantation.

Original languageEnglish
Pages (from-to)1-6
Number of pages6
JournalJournal of Gastroenterology
DOIs
Publication statusAccepted/In press - 2017 Jan 30

Fingerprint

Ribavirin
Living Donors
Hepacivirus
Liver Transplantation
Genotype
Infection
Therapeutics
sofosbuvir drug combination ledipasvir
Galectin 3
Liver
Virus Diseases
Pleural Effusion
Duodenal Ulcer
Clinical Protocols
Interferons
Antiviral Agents
Pneumonia
Japan
Cohort Studies
Genome

Keywords

  • Hepatitis C
  • Ledipasvir
  • Liver transplantation
  • Living donor
  • Sofosbuvir

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Treatment with sofosbuvir and ledipasvir without ribavirin for 12 weeks is highly effective for recurrent hepatitis C virus genotype 1b infection after living donor liver transplantation : a Japanese multicenter experience. / Ueda, Yoshihide; Ikegami, Toru; Akamatsu, Nobuhisa; Soyama, Akihiko; Shinoda, Masahiro; Goto, Ryoichi; Okajima, Hideaki; Yoshizumi, Tomoharu; Taketomi, Akinobu; Kitagawa, Yuukou; Eguchi, Susumu; Kokudo, Norihiro; Uemoto, Shinji; Maehara, Yoshihiko.

In: Journal of Gastroenterology, 30.01.2017, p. 1-6.

Research output: Contribution to journalArticle

Ueda, Yoshihide ; Ikegami, Toru ; Akamatsu, Nobuhisa ; Soyama, Akihiko ; Shinoda, Masahiro ; Goto, Ryoichi ; Okajima, Hideaki ; Yoshizumi, Tomoharu ; Taketomi, Akinobu ; Kitagawa, Yuukou ; Eguchi, Susumu ; Kokudo, Norihiro ; Uemoto, Shinji ; Maehara, Yoshihiko. / Treatment with sofosbuvir and ledipasvir without ribavirin for 12 weeks is highly effective for recurrent hepatitis C virus genotype 1b infection after living donor liver transplantation : a Japanese multicenter experience. In: Journal of Gastroenterology. 2017 ; pp. 1-6.
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abstract = "Background: The optimal therapy for recurrent hepatitis C virus (HCV) infection after liver transplantation has not yet been established. This study aimed to clarify the efficacy and safety of interferon-free therapy with sofosbuvir and ledipasvir without ribavirin for 12 weeks in Japanese patients with HCV genotype 1b infection after living donor liver transplantation. Methods: A cohort study of living donor liver transplant recipients with recurrent HCV genotype 1b infection treated with sofosbuvir (400 mg/day) and ledipasvir (90 mg/day) was performed at six liver transplant centers in Japan. Results: Fifty-four patients were treated with sofosbuvir and ledipasvir. Thirty-eight patients (70{\%}) were treatment experienced, including 17 patients who had undergone prior direct-acting-antiviral-based triple therapy. Ten patients had resistance-associated substitutions at L31 or Y93 in the NS5A region of the HCV genome. Fifty-three patients completed the 12-week treatment protocol; treatment was discontinued in one patient who developed pneumonia at 4 weeks and died thereafter. All 53 patients who completed the treatment regimen achieved a sustained virological response 12 weeks after completion of treatment. Treatment was well tolerated in most patients, but seven patients developed serious adverse events, including hemorrhagic duodenal ulcers (n = 3), infection (n = 2), pleural effusion (n = 1), and alveolar hemorrhage (n = 1). Conclusions: Sofosbuvir and ledipasvir treatment without ribavirin for 12 weeks was highly effective in achieving a sustained virological response in Japanese patients who developed recurrent HCV genotype 1b infection after living donor liver transplantation.",
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T1 - Treatment with sofosbuvir and ledipasvir without ribavirin for 12 weeks is highly effective for recurrent hepatitis C virus genotype 1b infection after living donor liver transplantation

T2 - a Japanese multicenter experience

AU - Ueda, Yoshihide

AU - Ikegami, Toru

AU - Akamatsu, Nobuhisa

AU - Soyama, Akihiko

AU - Shinoda, Masahiro

AU - Goto, Ryoichi

AU - Okajima, Hideaki

AU - Yoshizumi, Tomoharu

AU - Taketomi, Akinobu

AU - Kitagawa, Yuukou

AU - Eguchi, Susumu

AU - Kokudo, Norihiro

AU - Uemoto, Shinji

AU - Maehara, Yoshihiko

PY - 2017/1/30

Y1 - 2017/1/30

N2 - Background: The optimal therapy for recurrent hepatitis C virus (HCV) infection after liver transplantation has not yet been established. This study aimed to clarify the efficacy and safety of interferon-free therapy with sofosbuvir and ledipasvir without ribavirin for 12 weeks in Japanese patients with HCV genotype 1b infection after living donor liver transplantation. Methods: A cohort study of living donor liver transplant recipients with recurrent HCV genotype 1b infection treated with sofosbuvir (400 mg/day) and ledipasvir (90 mg/day) was performed at six liver transplant centers in Japan. Results: Fifty-four patients were treated with sofosbuvir and ledipasvir. Thirty-eight patients (70%) were treatment experienced, including 17 patients who had undergone prior direct-acting-antiviral-based triple therapy. Ten patients had resistance-associated substitutions at L31 or Y93 in the NS5A region of the HCV genome. Fifty-three patients completed the 12-week treatment protocol; treatment was discontinued in one patient who developed pneumonia at 4 weeks and died thereafter. All 53 patients who completed the treatment regimen achieved a sustained virological response 12 weeks after completion of treatment. Treatment was well tolerated in most patients, but seven patients developed serious adverse events, including hemorrhagic duodenal ulcers (n = 3), infection (n = 2), pleural effusion (n = 1), and alveolar hemorrhage (n = 1). Conclusions: Sofosbuvir and ledipasvir treatment without ribavirin for 12 weeks was highly effective in achieving a sustained virological response in Japanese patients who developed recurrent HCV genotype 1b infection after living donor liver transplantation.

AB - Background: The optimal therapy for recurrent hepatitis C virus (HCV) infection after liver transplantation has not yet been established. This study aimed to clarify the efficacy and safety of interferon-free therapy with sofosbuvir and ledipasvir without ribavirin for 12 weeks in Japanese patients with HCV genotype 1b infection after living donor liver transplantation. Methods: A cohort study of living donor liver transplant recipients with recurrent HCV genotype 1b infection treated with sofosbuvir (400 mg/day) and ledipasvir (90 mg/day) was performed at six liver transplant centers in Japan. Results: Fifty-four patients were treated with sofosbuvir and ledipasvir. Thirty-eight patients (70%) were treatment experienced, including 17 patients who had undergone prior direct-acting-antiviral-based triple therapy. Ten patients had resistance-associated substitutions at L31 or Y93 in the NS5A region of the HCV genome. Fifty-three patients completed the 12-week treatment protocol; treatment was discontinued in one patient who developed pneumonia at 4 weeks and died thereafter. All 53 patients who completed the treatment regimen achieved a sustained virological response 12 weeks after completion of treatment. Treatment was well tolerated in most patients, but seven patients developed serious adverse events, including hemorrhagic duodenal ulcers (n = 3), infection (n = 2), pleural effusion (n = 1), and alveolar hemorrhage (n = 1). Conclusions: Sofosbuvir and ledipasvir treatment without ribavirin for 12 weeks was highly effective in achieving a sustained virological response in Japanese patients who developed recurrent HCV genotype 1b infection after living donor liver transplantation.

KW - Hepatitis C

KW - Ledipasvir

KW - Liver transplantation

KW - Living donor

KW - Sofosbuvir

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