title: Daclatasvir and asunaprevir for genotype 1b chronic hepatitis C patients with chronic kidney disease.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of daclatasvir and asunaprevir combined therapy in genotype 1b chronic hepatitis C patients with non-dialysis chronic kidney disease (CKD).
  
  
  METHODS
  In a multicenter collaborative study, 249 patients received 60 mg daclatasvir (NS5A inhibitor) once a day and 100 mg of asunaprevir (NS3/4A protease inhibitor) twice a day for 24 weeks between September 2014 and September 2015 and were subjected to this analysis. Virological response and adverse events in non-dialysis patients with CKD (stage 3-5, excluding 5D: dialysis), which was defined as estimated glomerular filtration rate <60 mL/min/1.73 m2, were compared with those in patients without CKD.
  
  
  RESULTS
  Overall, the rates of rapid viral response, end-of-treatment response, and sustained virological response (SVR) were 76.7%, 91.2%, and 86.3%, respectively. Among 55 patients with CKD, the rapid viral response, end-of-treatment response, and SVR rates were 76.4%, 87.3%, and 83.6%, respectively. Among 194 patients without CKD, they were 76.8, 92.3, and 87.1%, respectively. There were no significant differences in the virological response rates between the two groups (P = 0.999, 0.282, and 0.509, respectively). The baseline estimated glomerular filtration rate did not affect the achievement of SVR. The incidence of adverse events in patients with and without CKD were 21.8% and 13.9%, respectively (not significant, P = 0.142).
  
  
  CONCLUSIONS
  The efficacy and safety of daclatasvir and asunaprevir combined therapy in genotype 1b chronic hepatitis C patients with non-dialysis CKD are not inferior to those in patients without CKD.
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Chiba, Japan.
authors.forename: Chisa
authors.initials: C
authors.lastname: Kondo
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Chiba, Japan.
authors.forename: Masanori
authors.initials: M
authors.lastname: Atsukawa
authors.affiliation: Core Research Facilities for Basic Science, Jikei University School of Medicine, Nishi-Shimbashi, Minato-ku, Tokyo, Japan.
authors.forename: Akihito
authors.initials: A
authors.lastname: Tsubota
authors.affiliation: Division of Gastroenterology and Hepatology, Otakanomori Hospital, Toyosiki, Kashiwa, Chiba, Japan.
authors.forename: Noritomo
authors.initials: N
authors.lastname: Shimada
authors.affiliation: Division of Gastroenterology and Hepatology, Shinmatsudo Central General Hospital, Shinmatsudo, Matsudo, Chiba, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Abe
authors.affiliation: Tokyo Metropolitan Bokutoh Hospital, Koutoubashi, Sumida, Tokyo, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Asano
authors.affiliation: Machida Municipal Hospital, Asahi-cho, Machida, Tokyo, Japan.
authors.forename: Kai
authors.initials: K
authors.lastname: Yoshizawa
authors.affiliation: Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Chiba, Japan.
authors.forename: Tomomi
authors.initials: T
authors.lastname: Okubo
authors.affiliation: Tokyo Metropolitan Bokutoh Hospital, Koutoubashi, Sumida, Tokyo, Japan.
authors.forename: Yoshimichi
authors.initials: Y
authors.lastname: Chuganji
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Jikei University School of Medicine Katsushika Medical Center, Aoto, Katsushika-ku, Tokyo, Japan.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Aizawa
authors.affiliation: Department of Virology and Liver Unit, Nagoya City University, Graduate School of Medical Sciences, Kawasumi, Mizuho, Aichi, Nagoya, Japan.
authors.forename: Etsuko
authors.initials: E
authors.lastname: Iio
authors.affiliation: Department of Virology and Liver Unit, Nagoya City University, Graduate School of Medical Sciences, Kawasumi, Mizuho, Aichi, Nagoya, Japan.
authors.forename: Yasuhito
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Sendagi, Bunkyo-ku, Tokyo, Japan.
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Iwakiri
keywords: asunaprevir; chronic hepatitis C; chronic kidney disease; daclatasvir; direct-acting antivirals; genotype 1