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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

  • Original Article—Liver, Pancreas, and Biliary Tract
  • Published:
Journal of Gastroenterology Aims and scope Submit manuscript

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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Abbreviations

DAA:

Direct-acting antiviral

ETR:

End-of treatment response

HCV:

Hepatitis C virus

IL:

Interleukin

LDLT:

Living donor liver transplantation

PCR:

Polymerase chain reaction

PPI:

Proton pump inhibitor

RVR:

Rapid virological response

SVR:

Sustained virological response

SVR12:

Sustained virological response at 12 weeks

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Acknowledgements

This research is supported by the Research Program on Hepatitis from the Japan Agency for Medical Research and Development (AMED).

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Authors and Affiliations

  1. Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan

    Yoshihide Ueda

  2. Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan

    Toru Ikegami, Tomoharu Yoshizumi & Yoshihiko Maehara

  3. Division of Artificial Organ and Transplantation, Department of Surgery, University of Tokyo, Tokyo, Japan

    Nobuhisa Akamatsu & Norihiro Kokudo

  4. Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan

    Akihiko Soyama & Susumu Eguchi

  5. Department of Surgery, Keio University School of Medicine, Tokyo, Japan

    Masahiro Shinoda & Yuko Kitagawa

  6. Department of Gastroenterological Surgery I, Hokkaido University Graduate School of Medicine, Hokkaido, Japan

    Ryoichi Goto & Akinobu Taketomi

  7. Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan

    Hideaki Okajima & Shinji Uemoto

Authors
  1. Yoshihide Ueda
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  2. Toru Ikegami
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  3. Nobuhisa Akamatsu
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  4. Akihiko Soyama
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  12. Norihiro Kokudo
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  13. Shinji Uemoto
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  14. Yoshihiko Maehara
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Correspondence to Yoshihide Ueda.

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Ueda, Y., Ikegami, T., Akamatsu, N. et al. 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. J Gastroenterol 52, 986–991 (2017). https://doi.org/10.1007/s00535-017-1310-9

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  • DOI: https://doi.org/10.1007/s00535-017-1310-9

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