title: Efficacy and safety of daclatasvir and asunaprevir combination therapy in chronic hemodialysis patients with chronic hepatitis C.
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.
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
authors.forename: Goki
authors.initials: G
authors.lastname: Suda
authors.affiliation: Sapporo Hokuyu Hospital, Hokkaido, Japan.
authors.forename: Mineo
authors.initials: M
authors.lastname: Kudo
authors.affiliation: Sapporo City General Hospital, Hokkaido, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Nagasaka
authors.affiliation: JCHO Hokkaido Hospital, Hokkaido, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Furuya
authors.affiliation: Hakodate City Hospital, Hokkaido, Japan.
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Yamamoto
authors.affiliation: Tomakomai City Hospital, Hokkaido, Japan.
authors.forename: Tomoe
authors.initials: T
authors.lastname: Kobayashi
authors.affiliation: Keiwakai Ebetsu Hospital, Hokkaido, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Shinada
authors.affiliation: Tomakomai Nissho Hospital, Hokkaido, Japan.
authors.forename: Miki
authors.initials: M
authors.lastname: Tateyama
authors.affiliation: Hakodate Central General Hospital, Hokkaido, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Konno
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.|Sapporo City General Hospital, Hokkaido, Japan.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Tsukuda
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
authors.forename: Kazushi
authors.initials: K
authors.lastname: Yamasaki
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
authors.forename: Megumi
authors.initials: M
authors.lastname: Kimura
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
authors.forename: Machiko
authors.initials: M
authors.lastname: Umemura
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
authors.forename: Takaaki
authors.initials: T
authors.lastname: Izumi
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Tsunematsu
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
authors.forename: Fumiyuki
authors.initials: F
authors.lastname: Sato
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
authors.forename: Katsumi
authors.initials: K
authors.lastname: Terashita
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Nakai
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.|Hakodate City Hospital, Hokkaido, Japan.
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Horimoto
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
authors.forename: Takuya
authors.initials: T
authors.lastname: Sho
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
authors.forename: Mitsuteru
authors.initials: M
authors.lastname: Natsuizaka
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Morikawa
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Ogawa
authors.affiliation: Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan. sakamoto@med.hokudai.ac.jp.
authors.forename: Naoya
authors.initials: N
authors.lastname: Sakamoto
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D002219:Carbamates; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D007546:Isoquinolines / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011759:Pyrrolidines; D006435:Renal Dialysis; D051437:Renal Insufficiency / Q000150:complications* / Q000628:therapy; D013449:Sulfonamides / Q000627:therapeutic use*; D014633:Valine / Q000031:analogs & derivatives
chemical_list: D000998:Antiviral Agents; D002219:Carbamates; D007093:Imidazoles; D007546:Isoquinolines; D011759:Pyrrolidines; D013449:Sulfonamides; D014633:Valine; C549273:daclatasvir; C571889:asunaprevir
keywords: Asunaprevir; Daclatasvir; HCV; Hemodialysis