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Hepatology International

, Volume 10, Issue 6, pp 947–955 | Cite as

A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus

  • Young-Suk Lim
  • Sang Hoon Ahn
  • Kwan Sik Lee
  • Seung Woon Paik
  • Youn-Jae Lee
  • Sook-Hyang Jeong
  • Ju-Hyun Kim
  • Seung Kew Yoon
  • Hyung Joon Yim
  • Won Young Tak
  • Sang-Young Han
  • Jenny C. Yang
  • Hongmei Mo
  • Kimberly L. Garrison
  • Bing Gao
  • Steven J. Knox
  • Phillip S. Pang
  • Yoon Jun Kim
  • Kwan-Soo Byun
  • Young Seok Kim
  • Jeong Heo
  • Kwang-Hyub HanEmail author
Original Article

Abstract

Background

The standard-of-care regimen for chronic hepatitis C virus (HCV) infection in Korea, pegylated-interferon-alpha plus ribavirin, is poorly tolerated. Ledipasvir/sofosbuvir is a two-drug, fixed-dose combination tablet approved in the USA, European Union, and Japan for chronic genotype 1 HCV infection.

Methods

This single-arm, phase IIIb study (NCT02021656) investigated the efficacy and safety of ledipasvir/sofosbuvir fixed-dose combination tablet for 12 weeks in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 HCV with or without compensated cirrhosis.

Results

The proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12) was 99 % (92/93), with rates of 100 % (46/46) and 98 % (46/47) in treatment-naïve and treatment-experienced patients, respectively. There were no on-treatment failures. One patient relapsed after the end of treatment. The most common treatment-emergent adverse events were headache (8 %, 7/93) and fatigue (6 %, 6/93). There were no grade 3 or 4 adverse events, seven grade 3 laboratory abnormalities, and one premature discontinuation of study treatment (due to nonserious mouth ulceration). None of the three reported serious adverse events were related to treatment.

Conclusions

These data suggest that 12 weeks of ledipasvir/sofosbuvir is effective and well tolerated in treatment-naïve and treatment-experienced Korean patients with chronic genotype 1 HCV infection.

Keywords

Genotype 1 Hepatitis C virus (HCV) Korea Ledipasvir Sofosbuvir 

Notes

Acknowledgements

This study was funded in full by Gilead Sciences, Inc. The writing and preparation of this paper were funded by Gilead Sciences, Inc. The initial data analyses were undertaken by the listed authors. Writing support was provided by Tiffany DeSimone, PhD, of BlueMomentum, an Ashfield Company, part of UDG Healthcare plc, and funded by Gilead Sciences, Inc.

Compliance with ethical statement

Conflict of interest

Young-Suk Lim has served as an advisor for Bayer Healthcare, Bristol-Myers Squibb, and Gilead Sciences, and has received research funding from Bayer Healthcare, Bristol-Myers Squibb, Gilead Sciences, and Novartis. Sang Hoon Ahn has served as an advisor and lecturer for Bristol-Myers Squibb, Gilead Sciences, F. Hoffmann-La Roche, Merck, Janssen, AbbVie, Novartis, Boeringher Ingelheim, and AVIVAX, and has received unrestricted grants from Bristol-Myers Squibb, Gilead Sciences, and F. Hoffmann-La Roche for investigator-initiated trials. Seung Woon Paik has received research funding from Bristol-Myers Squibb, Gilead Sciences, F. Hoffmann-La Roche, Merck, Janssen, and AbbVie. Hyung Joon Yim has received research funds from Handok Pharmacuetical Company and Gilead Sciences. Yoon Jun Kim has served as a speaker and advisory board member for Gilead Sciences, Bayer Healthcare, AbbVie, Novartis, and F. Hoffman-La Roche and has also received research funding from Gilead Sciences, Bristol-Myers Squibb, and F. Hoffman-La Roche. Kwan-Soo Byun has served as an advisory board member for Gilead Sciences and has received research funding from Gilead Sciences, Bristol-Myers Squibb, and Medigen Biotechnology Corporation. Jenny C. Yang, Hongmei Mo, Kimberly L. Garrison, Bing Gao, Steven J. Knox, and Phillip S. Pang are employees of and own stocks and shares in Gilead Sciences, Inc. Kwan Sik Lee, Youn-Jae Lee, Sook-Hyang Jeong, Ju-Hyun Kim, Seung Kew Yoon, Won Young Tak, Sang-Young Han, Young Seok Kim, Jeong Heo, and Kwang-Hyub Han have nothing to declare.

Studies with human subjects

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008. Written informed consent was obtained from all patients included in the study. The protocol was approved by the ethics committees/institutional review boards of participating centers and conformed to Good Clinical Practice guidelines and Declaration of Helsinki principles. This article does not contain any studies with animal subjects.

Supplementary material

12072_2016_9726_MOESM1_ESM.docx (55 kb)
Supplementary material 1 (DOCX 56 kb)

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Copyright information

© Asian Pacific Association for the Study of the Liver 2016

Authors and Affiliations

  • Young-Suk Lim
    • 1
  • Sang Hoon Ahn
    • 2
  • Kwan Sik Lee
    • 3
  • Seung Woon Paik
    • 4
  • Youn-Jae Lee
    • 5
  • Sook-Hyang Jeong
    • 6
  • Ju-Hyun Kim
    • 7
  • Seung Kew Yoon
    • 8
  • Hyung Joon Yim
    • 9
  • Won Young Tak
    • 10
  • Sang-Young Han
    • 11
  • Jenny C. Yang
    • 12
  • Hongmei Mo
    • 12
  • Kimberly L. Garrison
    • 12
  • Bing Gao
    • 12
  • Steven J. Knox
    • 12
  • Phillip S. Pang
    • 12
  • Yoon Jun Kim
    • 13
  • Kwan-Soo Byun
    • 14
  • Young Seok Kim
    • 15
  • Jeong Heo
    • 16
  • Kwang-Hyub Han
    • 2
    Email author
  1. 1.Department of GastroenterologyAsan Medical Center, University of Ulsan College of MedicineSeoulSouth Korea
  2. 2.Department of Internal MedicineYonsei University College of MedicineSeoulSouth Korea
  3. 3.Department of Gastroenterology and HepatologyGangnam Severance Hospital, Yonsei University Health SystemSeoulSouth Korea
  4. 4.Department of Medicine, Samsung Medical CenterSungkyunkwan University School of MedicineSeoulSouth Korea
  5. 5.Department of Infectious Diseases, Gastroenterology, and HepatologyInje University, Pusan Paik HospitalBusanSouth Korea
  6. 6.Department of Internal MedicineSeoul National University Bundang Hospital, Seoul National University College of MedicineSeongnamSouth Korea
  7. 7.Department of Internal MedicineGachon University Gil HospitalIncheonSouth Korea
  8. 8.Department of GastroenterologyThe Catholic University of Korea, Seoul St. Mary’s HospitalSeoulSouth Korea
  9. 9.Department of Internal MedicineKorea University Ansan HospitalAnsan-siSouth Korea
  10. 10.Department of Internal MedicineKyungpook National University Hospital, Kyungpook National University School of MedicineDaeguSouth Korea
  11. 11.Department of Internal MedicineDong-A University Medical CenterBusanSouth Korea
  12. 12.Gilead Sciences, IncFoster CityUSA
  13. 13.Department of Internal MedicineSeoul National University Hospital, Seoul National University College of Medicine and Liver Research InstituteSeoulSouth Korea
  14. 14.Department of Internal MedicineKorea University Guro HospitalSeoulSouth Korea
  15. 15.Department of Internal MedicineSoonchunhyang University Bucheon HospitalBucheonSouth Korea
  16. 16.Department of Internal MedicinePusan National University and Medical Research Institute, Pusan National University HospitalBusanSouth Korea

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