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Hepatol Res. 2017 Oct;47(11):1127-1136. doi: 10.1111/hepr.12851. Epub 2017 Jan 31.

Safety and efficacy of daclatasvir and asunaprevir in hepatitis C virus-infected patients with renal impairment.

Hepatology research : the official journal of the Japan Society of Hepatology

Goki Suda, Atsushi Nagasaka, Yoshiya Yamamoto, Ken Furuya, Kenichi Kumagai, Mineo Kudo, Katsumi Terashita, Tomoe Kobayashi, Izumi Tsunematsu, Junichi Yoshida, Takashi Meguro, Megumi Kimura, Jun Ito, Machiko Umemura, Takaaki Izumi, Seiji Tsunematsu, Fumiyuki Sato, Yoko Tsukuda, Masato Nakai, Takuya Sho, Mitsuteru Natsuizaka, Kenichi Morikawa, Koji Ogawa, Naoya Sakamoto,

Affiliations

  1. Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
  2. Department of Gastroenterology and Hepatology, Sapporo City General Hospital, Sapporo, Japan.
  3. Department of Gastroenterology and Hepatology, Hakodate City General Hospital, Hakodate, Japan.
  4. Department of Gastroenterology and Hepatology, JCHO Hokkaido Hospital, Sapporo, Japan.
  5. Department of Gastroenterology and Hepatology, Hakodate Medical Association Hospital, Hakodate, Japan.
  6. Department of Gastroenterology and Hepatology, Sapporo Hokuyu Hospital, Sapporo, Japan.
  7. Department of Gastroenterology and Hepatology, Kushiro Rosai Hospital, Kushiro, Japan.
  8. Department of Gastroenterology and Hepatology, Tomakomai City Hospital, Tomakomai, Japan.
  9. Department of Gastroenterology and Hepatology, Touei Hospital, Sapporo, Japan.
  10. Department of Gastroenterology and Hepatology, JCHO Sapporo Hokushin Hospital.
  11. Department of Gastroenterology and Hepatology, Hokkaido Gastroenterology Hospital, Sapporo, Japan.

PMID: 27943523 DOI: 10.1111/hepr.12851

Abstract

AIM: Hepatitis C virus (HCV) infection is a risk factor for end-stage renal disease, renal graft failure, and hemodialysis patient mortality. However, the efficacy of direct-acting antiviral therapy for HCV-infected patients with renal impairment is unclear. Additionally, the promising NS5B inhibitor sofosbuvir has not been recommended for patients with severe renal impairment. In this prospective, multicenter study, we evaluated the efficacy and safety of daclatasvir and asunaprevir combination therapy, with a focus on patients with renal impairment.

METHODS: The study included 322 genotype 1 HCV-infected patients who received daclatasvir and asunaprevir combination therapy. The safety and sustained virological response was examined at 12 weeks after the end of treatment and safety was evaluated according to renal function.

RESULTS: Of 322 patients, 5% (16/322) and 2.5% (8/322) had chronic kidney disease stage G3b (estimated glomerular filtration rate [eGFR], 30-44 mL/min/1.73 m

CONCLUSION: Daclatasvir and asunaprevir combination therapy for patients with renal dysfunction was highly effective and safe.

© 2016 The Japan Society of Hepatology.

Keywords: asunaprevir; daclatasvir; direct-acting antiviral; hepatitis C virus

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