Elbasvir/grazoprevir for hepatitis C virus genotype 1b East-Asian patients receiving hemodialysis.

Tytuł:: Elbasvir/grazoprevir for hepatitis C virus genotype 1b East-Asian patients receiving hemodialysis.
Autorzy:: Liu CH; Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.; Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Douliou, Taiwan.
Peng CY; School of Medicine, China Medical University, Taichung, Taiwan.; Center for Digestive Medicine, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Fang YJ; Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Douliou, Taiwan.
Kao WY; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan.; Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.; Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
Yang SS; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.; School of Medicine, Chung Shan Medical University, Taichung, Taiwan.; Rong Hsing Research Center for Translational Medicine, National Chung Hsing University, Taipei, Taiwan.; Ph.D. Program in Translational Medicine, National Chung Hsing University, Taichung, Taiwan.; Institute of Biomedical Sciences, National Chung Hsing University, Taichung, Taiwan.
Lin CK; Department of Internal Medicine, Far Eastern Memorial Hospital, New Taipei City, Taiwan.
Lai HC; School of Medicine, China Medical University, Taichung, Taiwan.; Center for Digestive Medicine, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Su WP; Center for Digestive Medicine, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Fang SU; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan.; Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
Chang CC; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan.; Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.; Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
Su TH; Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
Liu CJ; Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
Chen PJ; Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.; Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.
Chen DS; Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.; Genomics Research Center, Academia Sinica, Taipei, Taiwan.
Kao JH; Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. .; Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. .; Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan. .
Źródło:: Scientific reports [Sci Rep] 2020 Jun 08; Vol. 10 (1), pp. 9180. Date of Electronic Publication: 2020 Jun 08.
Typ publikacji:: Journal Article; Research Support, Non-U.S. Gov't
Język:: English
Imprint Name(s):: Original Publication: London : Nature Publishing Group, copyright 2011-
MeSH Terms:: Amides/*therapeutic use
Antiviral Agents/*therapeutic use
Benzofurans/*therapeutic use
Carbamates/*therapeutic use
Cyclopropanes/*therapeutic use
Hepacivirus/*drug effects
Hepatitis C, Chronic/*drug therapy
Imidazoles/*therapeutic use
Quinoxalines/*therapeutic use
Sulfonamides/*therapeutic use
Asian People ; Drug Resistance, Viral/drug effects ; Drug Therapy, Combination/methods ; Female ; Genotype ; Humans ; Male ; Middle Aged ; Renal Dialysis/adverse effects ; Sustained Virologic Response
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Substance Nomenclature:: 0 (Amides)
0 (Antiviral Agents)
0 (Benzofurans)
0 (Carbamates)
0 (Cyclopropanes)
0 (Imidazoles)
0 (Quinoxalines)
0 (Sulfonamides)
4O2AB118LA (grazoprevir)
632L571YDK (elbasvir)
Entry Date(s):: Date Created: 20200610 Date Completed: 20201204 Latest Revision: 20221207
Update Code:: 20240104
PubMed Central ID:: PMC7280513
DOI:: 10.1038/s41598-020-66182-8
PMID:: 32513953
: Czasopismo naukowe

Pełny tekst

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.

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