論文

基本情報

氏名 加藤 正樹
氏名(カナ) カトウ マサキ
氏名(英語) KATO MASAKI
所属 中村学園大学 栄養科学部 栄養科学科
職名 教授

題名

NS5A resistance-associated variants undermine the effectiveness of ledipasvir and sofosbuvir for cirrhotic patients infected with HCV genotype 1b

単著・共著の別

 

著者

Eiichi Ogawa
Norihiro Furusyo
Hideyuki Nomura
Kazufumi Dohmen
Nobuhiko Higashi
Kazuhiro Takahashi
Akira Kawano
Koichi Azuma
Takeaki Satoh
Makoto Nakamuta
Toshimasa Koyanagi
Masaki Kato
Shinji Shimoda
Eiji Kajiwara
Jun Hayashi

担当区分

 

概要

Background Little real-world cohort data has been reported for Asians who have received interferon-free regimens with sofosbuvir (SOF) for chronic hepatitis C virus (HCV) infection. We evaluated the effectiveness and safety in clinical practice of ledipasvir (LDV) plus SOF for Japanese patients infected with HCV genotype 1.
Methods This large, multicenter, real-world cohort study consisted of 772 patients treatment-naive or -experienced, with or without compensated cirrhosis, who were treated with LDV (90 mg)/SOF (400 mg) for a fixed 12-week duration. Direct sequence analysis of the NS5A genes (L31 and Y93) was performed at baseline.
Results Almost all (99.6%) were infected with HCV genotype 1b. The overall sustained virological response 12 weeks after the end of treatment (SVR12) rate was 98.8% (763/772). Multivariable logistic regression analysis extracted male (odds ratio [OR] 6.62, p = 0.024), cirrhosis (OR 20.1, p = 0.0054), and baseline NS5A resistance-associated variants (RAVs) (OR 29.3, p = 0.0018) as independently associated with treatment failure. Notably, the SVR12 rate for cirrhosis patients with baseline NS5A RAVs (87.5%, 49/56) was statistically lower than for the other groups. This tendency was found except for patients with prior daclatasvir/asunaprevir failure. All patients with treatment failure had NS5A Y93H at relapse, whether or not they had NS5A RAVs at baseline. Serious adverse effects were very rare, and discontinuation was required for only five (0.6%) patients.
Conclusions LDV/SOF for HCV genotype 1b was exceptionally effective, however, NS5A RAVs undermined the virological effect for cirrhosis patients. Moreover, LDV/SOF was shown to be safe, irrespective of age or fibrosis status.

発表雑誌等の名称

JOURNAL OF GASTROENTEROLOGY

出版者

SPRINGER JAPAN KK

52

7

開始ページ

845

終了ページ

854

発行又は発表の年月

2017-07

査読の有無

有り

招待の有無

無し

記述言語

英語

掲載種別

研究論文(学術雑誌)

国際・国内誌

 

国際共著

 

ISSN

 

eISSN

 

DOI

10.1007/s00535-016-1290-1

Cinii Articles ID

 

Cinii Books ID

 

Pubmed ID

 

PubMed Central 記事ID

 

形式

無償ダウンロード

JGlobalID

 

arXiv ID

 

ORCIDのPut Code

 

DBLP ID