PMID- 32513953
OWN - NLM
STAT- MEDLINE
DCOM- 20201204
LR  - 20221207
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 10
IP  - 1
DP  - 2020 Jun 8
TI  - Elbasvir/grazoprevir for hepatitis C virus genotype 1b East-Asian patients 
      receiving hemodialysis.
PG  - 9180
LID - 10.1038/s41598-020-66182-8 [doi]
LID - 9180
AB  - Data regarding the efficacy and tolerability of elbasvir/grazoprevir (EBR/GZR) 
      for East-Asian hepatitis C virus genotype 1b (HCV GT1b) patients receiving 
      hemodialysis were limited. We prospectively recruited 40 HCV GT1b hemodialysis 
      patients who received EBR/GZR for 12 weeks at 6 academic centers in Taiwan. The 
      efficacy endpoints were sustained virologic response 12 weeks off-therapy 
      (SVR(12)) by intention-to-treat (ITT) modified ITT (mITT) analyses. Patients' 
      baseline characteristics, early viral kinetics and HCV resistance-associated 
      substitutions (RASs) at HCV non-structural 3 and 5 A (NS3 and NS5A) regions 
      potentially affecting SVR(12) were analyzed. The tolerability for EBR/GZR was 
      also assessed. The SVR(12) rates by ITT and mITT analyses were 95% (38 of 40 
      patients; 95% confidence interval (CI): 83.5-98.6%) and 100% (38 of 38 patients; 
      95% CI: 90.8-100%), respectively. Patients' baseline characteristics, 
      on-treatment viral decline, and baseline HCV RASs did not affect SVR(12). All 
      patients tolerated treatment well. Among 5 patients who had serious adverse 
      events (AEs) including one death due to on-treatment suicide and the other death 
      due to off-therapy acute myocardial infarction, none of these events were judged 
      related to EBR/GZR. The common AEs included upper respiratory tract infection 
      (7.5%), fatigue (5.0%) and anorexia (5.0%). Nine (22.5%) and 8 (20.0%) patients 
      had on-treatment hemoglobin levels of 9.0-10.0 g/dL and 7.0-9.0 g/dL. Three 
      (7.5%) patients had on-treatment elevated alanine aminotransferase (ALT) quotient 
      > 2.5, in whom one (2.5%) had EBR/GZR-induced late ALT elevation. No patients 
      developed hyperbilirubinemia or hepatic decompensation. In conclusion, treatment 
      with EBR/GZR is effective and well-tolerated for East-Asian HCV GT1b patients 
      receiving hemodialysis.
FAU - Liu, Chen-Hua
AU  - Liu CH
AUID- ORCID: 0000-0003-3622-9707
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      National Taiwan University Hospital, Taipei, Taiwan.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      National Taiwan University Hospital, Yun-Lin Branch, Douliou, Taiwan.
FAU - Peng, Cheng-Yuan
AU  - Peng CY
AUID- ORCID: 0000-0001-9030-6086
AD  - School of Medicine, China Medical University, Taichung, Taiwan.
AD  - Center for Digestive Medicine, Department of Internal Medicine, China Medical 
      University Hospital, Taichung, Taiwan.
FAU - Fang, Yu-Jen
AU  - Fang YJ
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      National Taiwan University Hospital, Yun-Lin Branch, Douliou, Taiwan.
FAU - Kao, Wei-Yu
AU  - Kao WY
AUID- ORCID: 0000-0002-5506-4293
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Taipei Medical University Hospital, Taipei, Taiwan.
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      School of Medicine, College of Medicine, Taipei Medical University, Taipei, 
      Taiwan.
AD  - Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical 
      University, Taipei, Taiwan.
FAU - Yang, Sheng-Shun
AU  - Yang SS
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Taichung Veterans General Hospital, Taichung, Taiwan.
AD  - School of Medicine, Chung Shan Medical University, Taichung, Taiwan.
AD  - Rong Hsing Research Center for Translational Medicine, National Chung Hsing 
      University, Taipei, Taiwan.
AD  - Ph.D. Program in Translational Medicine, National Chung Hsing University, 
      Taichung, Taiwan.
AD  - Institute of Biomedical Sciences, National Chung Hsing University, Taichung, 
      Taiwan.
FAU - Lin, Cheng-Kuan
AU  - Lin CK
AD  - Department of Internal Medicine, Far Eastern Memorial Hospital, New Taipei City, 
      Taiwan.
FAU - Lai, Hsueh-Chou
AU  - Lai HC
AD  - School of Medicine, China Medical University, Taichung, Taiwan.
AD  - Center for Digestive Medicine, Department of Internal Medicine, China Medical 
      University Hospital, Taichung, Taiwan.
FAU - Su, Wen-Pang
AU  - Su WP
AD  - Center for Digestive Medicine, Department of Internal Medicine, China Medical 
      University Hospital, Taichung, Taiwan.
FAU - Fang, Sheng-Uei
AU  - Fang SU
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Taipei Medical University Hospital, Taipei, Taiwan.
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      School of Medicine, College of Medicine, Taipei Medical University, Taipei, 
      Taiwan.
FAU - Chang, Chun-Chao
AU  - Chang CC
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Taipei Medical University Hospital, Taipei, Taiwan.
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      School of Medicine, College of Medicine, Taipei Medical University, Taipei, 
      Taiwan.
AD  - Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical 
      University, Taipei, Taiwan.
FAU - Su, Tung-Hung
AU  - Su TH
AUID- ORCID: 0000-0002-6747-7941
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      National Taiwan University Hospital, Taipei, Taiwan.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
FAU - Liu, Chun-Jen
AU  - Liu CJ
AUID- ORCID: 0000-0001-8082-7144
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      National Taiwan University Hospital, Taipei, Taiwan.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
FAU - Chen, Pei-Jer
AU  - Chen PJ
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      National Taiwan University Hospital, Taipei, Taiwan.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
AD  - Graduate Institute of Clinical Medicine, National Taiwan University College of 
      Medicine, Taipei, Taiwan.
FAU - Chen, Ding-Shinn
AU  - Chen DS
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      National Taiwan University Hospital, Taipei, Taiwan.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
AD  - Genomics Research Center, Academia Sinica, Taipei, Taiwan.
FAU - Kao, Jia-Horng
AU  - Kao JH
AUID- ORCID: 0000-0002-2442-7952
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      National Taiwan University Hospital, Taipei, Taiwan. kaojh@ntu.edu.tw.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. 
      kaojh@ntu.edu.tw.
AD  - Graduate Institute of Clinical Medicine, National Taiwan University College of 
      Medicine, Taipei, Taiwan. kaojh@ntu.edu.tw.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200608
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 0 (Amides)
RN  - 0 (Antiviral Agents)
RN  - 0 (Benzofurans)
RN  - 0 (Carbamates)
RN  - 0 (Cyclopropanes)
RN  - 0 (Imidazoles)
RN  - 0 (Quinoxalines)
RN  - 0 (Sulfonamides)
RN  - 4O2AB118LA (grazoprevir)
RN  - 632L571YDK (elbasvir)
SB  - IM
MH  - Amides/*therapeutic use
MH  - Antiviral Agents/*therapeutic use
MH  - Asian People
MH  - Benzofurans/*therapeutic use
MH  - Carbamates/*therapeutic use
MH  - Cyclopropanes/*therapeutic use
MH  - Drug Resistance, Viral/drug effects
MH  - Drug Therapy, Combination/methods
MH  - Female
MH  - Genotype
MH  - Hepacivirus/*drug effects
MH  - Hepatitis C, Chronic/*drug therapy
MH  - Humans
MH  - Imidazoles/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Quinoxalines/*therapeutic use
MH  - Renal Dialysis/adverse effects
MH  - Sulfonamides/*therapeutic use
MH  - Sustained Virologic Response
PMC - PMC7280513
COIS- Dr. Chen-Hua Liu has received compensations as a member of the scientific 
      advisory board for Abbvie and Gilead Sciences. He has consulted for Abbott, 
      AbbVie, Gilead Sciences, and Merck Sharp & Dohme, and received compensations. He 
      also has received research grants from Abbvie, Gilead Sciences, and Merck Sharp & 
      Dohme. Dr. Chun-Jen Liu has received compensations as a member of the scientific 
      advisory board for Gilead Sciences and Merck Sharp & Dohme. He has consulted for 
      AbbVie, Gilead Sciences, and Merck Sharp & Dohme, and received compensations. He 
      also has received research grant from Gilead Sciences. Dr. Jia-Horng Kao has 
      received compensations as a member of the scientific advisory board for Abbott, 
      AbbVie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & 
      Dohme, Novartis, and Roche. He has consulted for Abbott, AbbVie, Bayer, 
      Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme, 
      Novartis, and Roche and received compensations. Dr. Ding-Shinn Chen has received 
      compensations as a member of the scientific advisory board for Abbvie, Gilead 
      Sciences, GlaxoSmithKline, Merck Sharp & Dohme, and Novartis. Dr. Pei-Jer Chen 
      has received compensations as a member of the scientific advisory board for 
      AbbVie, Novartis, and Roche. All other authors declare no potential conflict of 
      interest.
EDAT- 2020/06/10 06:00
MHDA- 2020/12/15 06:00
PMCR- 2020/06/08
CRDT- 2020/06/10 06:00
PHST- 2020/01/22 00:00 [received]
PHST- 2020/05/12 00:00 [accepted]
PHST- 2020/06/10 06:00 [entrez]
PHST- 2020/06/10 06:00 [pubmed]
PHST- 2020/12/15 06:00 [medline]
PHST- 2020/06/08 00:00 [pmc-release]
AID - 10.1038/s41598-020-66182-8 [pii]
AID - 66182 [pii]
AID - 10.1038/s41598-020-66182-8 [doi]
PST - epublish
SO  - Sci Rep. 2020 Jun 8;10(1):9180. doi: 10.1038/s41598-020-66182-8.