Efficacy and safety of daclatasvir and asunaprevir in patients with hepatitis C virus genotype 1b infection on hemodialysis

Byung Seok Lee, Myeong Jun Song, Jung Hyun Kwon, Tae Hee Lee, Ji Woong Jang, Seok Hyun Kim, Sae Hwan Lee, Hong Soo Kim, Ji Hoon Kim, Seok Bae Kim, Soon Young Ko, Do Seon Song

Research output: Contribution to journalArticle

Abstract

Background/Aims: We evaluated the efficacy and safety of daclatasvir (DCV) and asunaprevir (ASV) in patients with chronic hepatitis C virus (HCV) infection on hemodialysis. Methods: We performed a single-arm, multicenter prospective study. Twenty-one chronic hemodialysis patients with HCV infection were prospectively enrolled from February 2016 to April 2017. We evaluated the virological responses at weeks 4, 12, and 24 (end of treatment [EOT]) and the sustained virological response at 12 weeks after the EOT (SVR12). The tolerability and safety of the drugs were also assessed. Results: None of the 20 patients had the NS5A resistance-associated variant (NS5A RAV), and one patient was indeterminate for the NS5A RAV. Seventeen patients (80%) completed the 24 weeks of treatment with DCV and ASV. Four patients discontinued the study prior to week 12. In an intention-to-treat analysis, the SVR12 was 76.1%. In a per-protocol analysis, patients who completed DCV and ASV treatment achieved an SVR12 of 100%. DCV and ASV were well tolerated by the majority of patients. Three patients discontinued treatment due to adverse events (AEs) including dizziness, dyspnea, and neutropenia. The patient with indeterminate NS5A RAV showed viral breakthrough and discontinued treatment. Conclusions: DCV and ASV combination therapy in chronic hemodialysis patients with HCV infection achieved a high SVR12 rate with few AEs. To maximize the SVR12 rate, it is important to identify candidates by baseline RAV testing. Close monitoring of the safety and tolerability of DCV and ASV may be necessary in HCV-infected patients on hemodialysis.

Original languageEnglish
Pages (from-to)191-196
Number of pages6
JournalGut and Liver
Volume13
Issue number2
DOIs
Publication statusPublished - 2019 Mar 1

Fingerprint

Hepacivirus
Renal Dialysis
Genotype
Safety
Infection
Virus Diseases
Therapeutics
BMS-790052
asunaprevir
Intention to Treat Analysis
Dizziness
Chronic Hepatitis C
Neutropenia
Dyspnea
Multicenter Studies
Prospective Studies

Keywords

  • Asunaprevir
  • Chronic hepatitis C virus
  • Daclatasvir
  • Hemodialysis
  • Sustained virologic response

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Lee, B. S., Song, M. J., Kwon, J. H., Lee, T. H., Jang, J. W., Kim, S. H., ... Song, D. S. (2019). Efficacy and safety of daclatasvir and asunaprevir in patients with hepatitis C virus genotype 1b infection on hemodialysis. Gut and Liver, 13(2), 191-196. https://doi.org/10.5009/gnl18240

Efficacy and safety of daclatasvir and asunaprevir in patients with hepatitis C virus genotype 1b infection on hemodialysis. / Lee, Byung Seok; Song, Myeong Jun; Kwon, Jung Hyun; Lee, Tae Hee; Jang, Ji Woong; Kim, Seok Hyun; Lee, Sae Hwan; Kim, Hong Soo; Kim, Ji Hoon; Kim, Seok Bae; Ko, Soon Young; Song, Do Seon.

In: Gut and Liver, Vol. 13, No. 2, 01.03.2019, p. 191-196.

Research output: Contribution to journalArticle

Lee, BS, Song, MJ, Kwon, JH, Lee, TH, Jang, JW, Kim, SH, Lee, SH, Kim, HS, Kim, JH, Kim, SB, Ko, SY & Song, DS 2019, 'Efficacy and safety of daclatasvir and asunaprevir in patients with hepatitis C virus genotype 1b infection on hemodialysis', Gut and Liver, vol. 13, no. 2, pp. 191-196. https://doi.org/10.5009/gnl18240
Lee, Byung Seok ; Song, Myeong Jun ; Kwon, Jung Hyun ; Lee, Tae Hee ; Jang, Ji Woong ; Kim, Seok Hyun ; Lee, Sae Hwan ; Kim, Hong Soo ; Kim, Ji Hoon ; Kim, Seok Bae ; Ko, Soon Young ; Song, Do Seon. / Efficacy and safety of daclatasvir and asunaprevir in patients with hepatitis C virus genotype 1b infection on hemodialysis. In: Gut and Liver. 2019 ; Vol. 13, No. 2. pp. 191-196.
@article{e72536233b96498d84be659e818e4928,
title = "Efficacy and safety of daclatasvir and asunaprevir in patients with hepatitis C virus genotype 1b infection on hemodialysis",
abstract = "Background/Aims: We evaluated the efficacy and safety of daclatasvir (DCV) and asunaprevir (ASV) in patients with chronic hepatitis C virus (HCV) infection on hemodialysis. Methods: We performed a single-arm, multicenter prospective study. Twenty-one chronic hemodialysis patients with HCV infection were prospectively enrolled from February 2016 to April 2017. We evaluated the virological responses at weeks 4, 12, and 24 (end of treatment [EOT]) and the sustained virological response at 12 weeks after the EOT (SVR12). The tolerability and safety of the drugs were also assessed. Results: None of the 20 patients had the NS5A resistance-associated variant (NS5A RAV), and one patient was indeterminate for the NS5A RAV. Seventeen patients (80{\%}) completed the 24 weeks of treatment with DCV and ASV. Four patients discontinued the study prior to week 12. In an intention-to-treat analysis, the SVR12 was 76.1{\%}. In a per-protocol analysis, patients who completed DCV and ASV treatment achieved an SVR12 of 100{\%}. DCV and ASV were well tolerated by the majority of patients. Three patients discontinued treatment due to adverse events (AEs) including dizziness, dyspnea, and neutropenia. The patient with indeterminate NS5A RAV showed viral breakthrough and discontinued treatment. Conclusions: DCV and ASV combination therapy in chronic hemodialysis patients with HCV infection achieved a high SVR12 rate with few AEs. To maximize the SVR12 rate, it is important to identify candidates by baseline RAV testing. Close monitoring of the safety and tolerability of DCV and ASV may be necessary in HCV-infected patients on hemodialysis.",
keywords = "Asunaprevir, Chronic hepatitis C virus, Daclatasvir, Hemodialysis, Sustained virologic response",
author = "Lee, {Byung Seok} and Song, {Myeong Jun} and Kwon, {Jung Hyun} and Lee, {Tae Hee} and Jang, {Ji Woong} and Kim, {Seok Hyun} and Lee, {Sae Hwan} and Kim, {Hong Soo} and Kim, {Ji Hoon} and Kim, {Seok Bae} and Ko, {Soon Young} and Song, {Do Seon}",
year = "2019",
month = "3",
day = "1",
doi = "10.5009/gnl18240",
language = "English",
volume = "13",
pages = "191--196",
journal = "Gut and Liver",
issn = "1976-2283",
publisher = "Joe Bok Chung",
number = "2",

}

TY - JOUR

T1 - Efficacy and safety of daclatasvir and asunaprevir in patients with hepatitis C virus genotype 1b infection on hemodialysis

AU - Lee, Byung Seok

AU - Song, Myeong Jun

AU - Kwon, Jung Hyun

AU - Lee, Tae Hee

AU - Jang, Ji Woong

AU - Kim, Seok Hyun

AU - Lee, Sae Hwan

AU - Kim, Hong Soo

AU - Kim, Ji Hoon

AU - Kim, Seok Bae

AU - Ko, Soon Young

AU - Song, Do Seon

PY - 2019/3/1

Y1 - 2019/3/1

N2 - Background/Aims: We evaluated the efficacy and safety of daclatasvir (DCV) and asunaprevir (ASV) in patients with chronic hepatitis C virus (HCV) infection on hemodialysis. Methods: We performed a single-arm, multicenter prospective study. Twenty-one chronic hemodialysis patients with HCV infection were prospectively enrolled from February 2016 to April 2017. We evaluated the virological responses at weeks 4, 12, and 24 (end of treatment [EOT]) and the sustained virological response at 12 weeks after the EOT (SVR12). The tolerability and safety of the drugs were also assessed. Results: None of the 20 patients had the NS5A resistance-associated variant (NS5A RAV), and one patient was indeterminate for the NS5A RAV. Seventeen patients (80%) completed the 24 weeks of treatment with DCV and ASV. Four patients discontinued the study prior to week 12. In an intention-to-treat analysis, the SVR12 was 76.1%. In a per-protocol analysis, patients who completed DCV and ASV treatment achieved an SVR12 of 100%. DCV and ASV were well tolerated by the majority of patients. Three patients discontinued treatment due to adverse events (AEs) including dizziness, dyspnea, and neutropenia. The patient with indeterminate NS5A RAV showed viral breakthrough and discontinued treatment. Conclusions: DCV and ASV combination therapy in chronic hemodialysis patients with HCV infection achieved a high SVR12 rate with few AEs. To maximize the SVR12 rate, it is important to identify candidates by baseline RAV testing. Close monitoring of the safety and tolerability of DCV and ASV may be necessary in HCV-infected patients on hemodialysis.

AB - Background/Aims: We evaluated the efficacy and safety of daclatasvir (DCV) and asunaprevir (ASV) in patients with chronic hepatitis C virus (HCV) infection on hemodialysis. Methods: We performed a single-arm, multicenter prospective study. Twenty-one chronic hemodialysis patients with HCV infection were prospectively enrolled from February 2016 to April 2017. We evaluated the virological responses at weeks 4, 12, and 24 (end of treatment [EOT]) and the sustained virological response at 12 weeks after the EOT (SVR12). The tolerability and safety of the drugs were also assessed. Results: None of the 20 patients had the NS5A resistance-associated variant (NS5A RAV), and one patient was indeterminate for the NS5A RAV. Seventeen patients (80%) completed the 24 weeks of treatment with DCV and ASV. Four patients discontinued the study prior to week 12. In an intention-to-treat analysis, the SVR12 was 76.1%. In a per-protocol analysis, patients who completed DCV and ASV treatment achieved an SVR12 of 100%. DCV and ASV were well tolerated by the majority of patients. Three patients discontinued treatment due to adverse events (AEs) including dizziness, dyspnea, and neutropenia. The patient with indeterminate NS5A RAV showed viral breakthrough and discontinued treatment. Conclusions: DCV and ASV combination therapy in chronic hemodialysis patients with HCV infection achieved a high SVR12 rate with few AEs. To maximize the SVR12 rate, it is important to identify candidates by baseline RAV testing. Close monitoring of the safety and tolerability of DCV and ASV may be necessary in HCV-infected patients on hemodialysis.

KW - Asunaprevir

KW - Chronic hepatitis C virus

KW - Daclatasvir

KW - Hemodialysis

KW - Sustained virologic response

UR - http://www.scopus.com/inward/record.url?scp=85063351717&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85063351717&partnerID=8YFLogxK

U2 - 10.5009/gnl18240

DO - 10.5009/gnl18240

M3 - Article

VL - 13

SP - 191

EP - 196

JO - Gut and Liver

JF - Gut and Liver

SN - 1976-2283

IS - 2

ER -