A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naïve and treatment-experienced Korean patients chronically infected with genotype 1 ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2016-05-20

AUTHORS

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 Han

ABSTRACT

BackgroundThe 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.MethodsThis 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.ResultsThe 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.ConclusionsThese 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. More... »

PAGES

947-955

Journal

TITLE

Hepatology International

ISSUE

6

VOLUME

10

Author Affiliations

  • Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
  • Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, 120-752, Seoul, South Korea
  • Department of Gastroenterology and Hepatology, Gangnam Severance Hospital, Yonsei University Health System, Seoul, South Korea
  • Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
  • Department of Infectious Diseases, Gastroenterology, and Hepatology, Inje University, Pusan Paik Hospital, Busan, South Korea
  • Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea
  • Department of Internal Medicine, Gachon University Gil Hospital, Incheon, South Korea
  • Department of Gastroenterology, The Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul, South Korea
  • Department of Internal Medicine, Korea University Ansan Hospital, Ansan-si, Gyeonggi-do, South Korea
  • Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, South Korea
  • Department of Internal Medicine, Dong-A University Medical Center, Busan, South Korea
  • Gilead Sciences, Inc, Foster City, CA, USA
  • Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine and Liver Research Institute, Seoul, South Korea
  • Department of Internal Medicine, Korea University Guro Hospital, Seoul, South Korea
  • Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, South Korea
  • Department of Internal Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital, Busan, South Korea
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s12072-016-9726-5

    DOI

    http://dx.doi.org/10.1007/s12072-016-9726-5

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1042793044

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/27198664


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