Elbasvir/grazoprevir is effective and tolerable for the treatment of HCV GT1-infected patients: A real world multicenter observatory study in Taiwan
Journal
Journal of Microbiology, Immunology and Infection
Journal Volume
54
Journal Issue
4
Pages
588-595
Date Issued
2021
Author(s)
Cheng P.-N.
Chen C.-Y.
Yu M.-L.
Lin C.-C.
Lin C.-Y.
Peng C.-Y.
Tseng K.-C.
Lo C.-C.
Tseng I.-H.
Abstract
Background & aims: Treatment of hepatitis C virus (HCV) by elbasvir/grazoprevir (EBR/GZR) was found to be efficacious and well tolerated in clinical trials. This study aimed to evaluate the effectiveness and tolerability of EBR/GZR in the treatment of HCV genotype 1-infected Taiwanese patients. Methods: Chronic hepatitis C patients infected with GT1b or 1a without resistance-associated substitution, and treated with 12-week EBR/GZR were enrolled from 10 hospitals in Taiwan between August 2017 and December 2018. All clinical and virologic data were collected at each participating center. Primary efficacy endpoint was sustained virologic response at week 12 (SVR12) after end of the EBR/GZR therapy, assessed in the per-protocol population, which excluded patients with important deviations from the protocol. Analysis was also performed based on the modified full analysis set, which included all allocated patients receiving at least 4-week medication. Virologic failure was recorded as breakthrough, nonresponse, or relapse. Safety was assessed through collection of adverse events, physical examination, vital signs, and standard laboratory evaluations. Results: Per protocol SVR12 rates were 99.5% (1169/1175) for all HCV genotype 1 patients. Among patients with stage 4 or 5 chronic kidney diseases, 100% (107/107) achieved SVR12. In univariate analyses, variables associated with SVR12 were treatment termination (P < 0.0001) and treatment adherence (P < 0.0001) in the mFAS population. Overall, 22.3% of the patients experienced adverse events during treatment. Seven patients did not complete the treatment, five due to liver-unrelated deaths, one due to adverse event and one due to epilepsy. Conclusions: EBR/GZR treatment was highly effective and well tolerated. ? 2020
Subjects
EBR/GZR; Effectiveness; Genotype 1; HCV; Tolerability
SDGs
Other Subjects
albumin; bilirubin; creatinine; elbasvir plus grazoprevir; peginterferon; antivirus agent; benzofuran derivative; elbasvir-grazoprevir drug combination; imidazole derivative; quinoxaline derivative; aged; antiviral therapy; Article; brain hemorrhage; cardiovascular disease; Child Pugh score; chronic hepatitis C; chronic kidney failure; clinical article; comparative study; controlled study; coughing; dizziness; drug efficacy; drug safety; drug tolerability; epigastric pain; fatigue; female; headache; Hepatitis C virus genotype 1; human; insomnia; laboratory test; male; multicenter study; nonhuman; patient compliance; physical examination; pruritus; severe asthma; severe renal impairment; sustained virologic response; Taiwan; vital sign; chronic hepatitis C; classification; clinical trial; drug combination; drug effect; genetics; genotype; Hepacivirus; middle aged; treatment outcome; Aged; Antiviral Agents; Benzofurans; Drug Combinations; Female; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Male; Middle Aged; Quinoxalines; Sustained Virologic Response; Taiwan; Treatment Outcome
Publisher
Elsevier Ltd
Type
journal article