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Efficacy and safety of daclatasvir and asunaprevir combination therapy in chronic hemodialysis patients with chronic hepatitis C

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Title: Efficacy and safety of daclatasvir and asunaprevir combination therapy in chronic hemodialysis patients with chronic hepatitis C
Authors: Suda, Goki Browse this author →KAKEN DB
Kudo, Mineo Browse this author
Nagasaka, Atsushi Browse this author
Furuya, Ken Browse this author
Yamamoto, Yoshiya Browse this author
Kobayashi, Tomoe Browse this author
Shinada, Keisuke Browse this author
Tateyama, Miki Browse this author
Konno, Jun Browse this author
Tsukuda, Yoko Browse this author
Yamasaki, Kazushi Browse this author
Kimura, Megumi Browse this author
Umemura, Machiko Browse this author
Izumi, Takaaki Browse this author
Tsunematsu, Seiji Browse this author
Sato, Fumiyuki Browse this author
Terashita, Katsumi Browse this author
Nakai, Masato Browse this author
Horimoto, Hiromasa Browse this author
Sho, Takuya Browse this author
Natsuizaka, Mitsuteru Browse this author
Morikawa, Kenichi Browse this author
Ogawa, Koji Browse this author
Sakamoto, Naoya Browse this author →KAKEN DB
Keywords: HCV
Hemodialysis
Daclatasvir
Asunaprevir
Issue Date: Jul-2016
Publisher: Springer
Journal Title: Journal of gastroenterology
Volume: 51
Issue: 7
Start Page: 733
End Page: 740
Publisher DOI: 10.1007/s00535-016-1162-8
PMID: 26768604
Abstract: Background: HCV infection in chronic hemodialysis patients is high, has a poor prognosis and high risk of renal graft failure, and requires nosocomial infection control measures. However, options of anti-HCV therapy in such patients are limited and unsatisfactory. In this study, we report effectiveness and safety of HCV-NS5A-inhibitor daclatasvir (DCV) and protease-inhibitor asunaprevir (ASV) combination therapy for hemodialysis patients with HCV infection. Methods: This study was registered at the UMIN Clinical Trials Registry as UMIN000016355. Thirty-four dialysis patients were treated with DCV/ASV combination therapy between January 2015 and November 2015. Of those, 21 patients who were followed more than 12 weeks after treatment ended were included. We evaluated the 12-week sustained virologic response (SVR12) and adverse events during treatment. Results: Of the 21 patients, four had compensated liver cirrhosis and three had resistance-associated variant of NS5A (NS5A RAVs)-Y93H at baseline. Overall, total of 95.5 % (20/21) of the patients achieved SVR12. Of note, all patients with cirrhosis or NS5A RAVs achieved SVR12. One relapser patient at 4 weeks post-treatment had NS3 D168E RAVs at baseline. A total of 20 patients (95.5 %) completed the 24-week therapy. One patient discontinued treatment at week 12 due to ALT elevations and achieved SVR12. Conclusions: DAV and ASV combination therapy for chronic hemodialysis patients with HCV infection was highly effective and well tolerated, even in elderly patients and patients with liver cirrhosis and NS5A-RAVs.
Rights: The final publication is available at Springer via http://dx.doi.org/10.1007/s00535-016-1162-8
Type: article (author version)
URI: http://hdl.handle.net/2115/66412
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 須田 剛生

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