title: 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.
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.
authors.affiliation: Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors.forename: Young-Suk
authors.initials: YS
authors.lastname: Lim
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea.
authors.forename: Sang Hoon
authors.initials: SH
authors.lastname: Ahn
authors.affiliation: Department of Gastroenterology and Hepatology, Gangnam Severance Hospital, Yonsei University Health System, Seoul, South Korea.
authors.forename: Kwan Sik
authors.initials: KS
authors.lastname: Lee
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
authors.forename: Seung Woon
authors.initials: SW
authors.lastname: Paik
authors.affiliation: Department of Infectious Diseases, Gastroenterology, and Hepatology, Inje University, Pusan Paik Hospital, Busan, South Korea.
authors.forename: Youn-Jae
authors.initials: YJ
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.
authors.forename: Sook-Hyang
authors.initials: SH
authors.lastname: Jeong
authors.affiliation: Department of Internal Medicine, Gachon University Gil Hospital, Incheon, South Korea.
authors.forename: Ju-Hyun
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Department of Gastroenterology, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, South Korea.
authors.forename: Seung Kew
authors.initials: SK
authors.lastname: Yoon
authors.affiliation: Department of Internal Medicine, Korea University Ansan Hospital, Ansan-si, Gyeonggi-do, South Korea.
authors.forename: Hyung Joon
authors.initials: HJ
authors.lastname: Yim
authors.affiliation: Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, South Korea.
authors.forename: Won Young
authors.initials: WY
authors.lastname: Tak
authors.affiliation: Department of Internal Medicine, Dong-A University Medical Center, Busan, South Korea.
authors.forename: Sang-Young
authors.initials: SY
authors.lastname: Han
authors.affiliation: Gilead Sciences, Inc, Foster City, CA, USA.
authors.forename: Jenny C
authors.initials: JC
authors.lastname: Yang
authors.affiliation: Gilead Sciences, Inc, Foster City, CA, USA.
authors.forename: Hongmei
authors.initials: H
authors.lastname: Mo
authors.affiliation: Gilead Sciences, Inc, Foster City, CA, USA.
authors.forename: Kimberly L
authors.initials: KL
authors.lastname: Garrison
authors.affiliation: Gilead Sciences, Inc, Foster City, CA, USA.
authors.forename: Bing
authors.initials: B
authors.lastname: Gao
authors.affiliation: Gilead Sciences, Inc, Foster City, CA, USA.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Knox
authors.affiliation: Gilead Sciences, Inc, Foster City, CA, USA.
authors.forename: Phillip S
authors.initials: PS
authors.lastname: Pang
authors.affiliation: Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine and Liver Research Institute, Seoul, South Korea.
authors.forename: Yoon Jun
authors.initials: YJ
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Korea University Guro Hospital, Seoul, South Korea.
authors.forename: Kwan-Soo
authors.initials: KS
authors.lastname: Byun
authors.affiliation: Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, South Korea.
authors.forename: Young Seok
authors.initials: YS
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital, Busan, South Korea.
authors.forename: Jeong
authors.initials: J
authors.lastname: Heo
authors.affiliation: Department of Internal Medicine, Yonsei University College of Medicine, 50 Yonsei-ro, Seodaemun-gu, Seoul, 120-752, South Korea. gihankhys@yuhs.ac.
authors.forename: Kwang-Hyub
authors.initials: KH
authors.lastname: Han
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage* / Q000009:adverse effects; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D056910:Republic of Korea; D000069474:Sofosbuvir; D000072230:Sustained Virologic Response; D013607:Tablets; D016896:Treatment Outcome; D014542:Uridine Monophosphate / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D001562:Benzimidazoles; D005449:Fluorenes; D013607:Tablets; C000595958:ledipasvir, sofosbuvir drug combination; D014542:Uridine Monophosphate; D000069474:Sofosbuvir
keywords: Genotype 1; Hepatitis C virus (HCV); Korea; Ledipasvir; Sofosbuvir