Efficacy and safety of daclatasvir and asunaprevir combination therapy in chronic hemodialysis patients with chronic hepatitis C
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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.
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.
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.
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.
KeywordsHCV Hemodialysis Daclatasvir Asunaprevir
Hepatitis C virus
Chronic hepatitis C
Sustained virological response
The authors would like to thank all patients and their families as well as the investigators and staff of the 21 participating institutions. The principal investigators of the NORTE study sites are listed below: Junichi Yoshida (JCHO Sapporo Hokushin Hospital), Atsushi Nagasaka (Sapporo City General Hospital), Akira Fuzinaga, Manabu Onodera (Abashiri-Kosei General Hospital), Hideaki Kikuchi, Tomofumi Atarashi (Obihiro-Kosei General Hospital), Ken Furuya (JCHO Hokkaido Hospital), Shuichi Muto (National Hospital Organization Hokkaido Medical Center), Takashi Meguro (Hokkaido Gastroenterology Hospital), Akiyoshi Saga (Aiiku Hospital), Mineo Kudou (Sapporo Hokuyu Hospital), Takuto Miyagishima (Kushiro Rosai Hospital), Jun Konno (Hakodate Central General Hospital), Kenichi Kumagai (Hakodate Medical Association Hospital), Nobuaki Akakura (NTT EAST Sapporo Hospital), Tomoe Kobayashi (Tomakomai City Hospital), Minoru Uebayashi (Japanese Red Cross Kitami Hospital), Kanji Katou (Iwamizawa Municipal General Hospital), Yasuyuki Kunieda (Wakkanai City Hospital), Miki Tateyama (Tomakomai Nissho Hospital), Munenori Okamoto (Sapporo Century Hospital), Izumi Tsunematsu (Touei hospital), Keisuke Shinada (Keiwakai Ebetsu Hospital) and Yoshiya Ymamoto (Hakodate City General Hospital).
This study was supported in part by grants from the Ministry of Education, Culture, Sports, Science and Technology of Japan, the Japan Society for the Promotion of Science, the Japan Agency for Medical Research and Development and the Ministry of Health, Labour and Welfare of Japan.
Compliance with ethical standards
Conflict of interest
Professor Naoya Sakamoto received lecture fees from Bristol Myers Squibb and Pharmaceutical K.K, grants and endowments from MSD K. K and Chugai Pharmaceutical Co., Ltd, and research grant from Gilead Sciences. Inc. Dr Goki Suda received research grants from Bristol Myers Squibb. The other authors have nothing to disclose.
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