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Safety and efficacy of faldaprevir in combination with pegylated interferon α-2b and ribavirin in Japanese patients with genotype-1 chronic hepatitis C virus infection.

Authors
  • Nishiguchi, Shuhei1
  • Urano, Yasuhisa2
  • Suzaki, Keiko2
  • Taniguchi, Atsushi2
  • Scherer, Joseph3
  • Berger, Kristi L3
  • Quinson, Anne-Marie3
  • Stern, Jerry O3
  • Omata, Masao4
  • 1 Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan. , (Japan)
  • 2 Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan. , (Japan)
  • 3 Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield Connecticut, USA.
  • 4 Department of Gastroenterology, Yamanashi Prefectural Central Hospital, Kofu, Japan. , (Japan)
Type
Published Article
Journal
Hepatology research : the official journal of the Japan Society of Hepatology
Publication Date
Mar 01, 2017
Volume
47
Issue
3
Identifiers
DOI: 10.1111/hepr.12741
PMID: 27153246
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

We evaluated the safety and efficacy of the hepatitis C virus (HCV) NS3/4A A protease inhibitor faldaprevir plus pegylated interferon α-2b and ribavirin (PegIFNα-2b/RBV) in Japanese patients with HCV genotype-1 infection. Treatment-naïve patients were randomized (1:1) to faldaprevir 120 mg q.d. for 12 or 24 weeks (response-guided therapy [RGT], n = 44), or faldaprevir 240 mg q.d. for 12 weeks (n = 43), each combined with PegIFNα-2b/RBV for 24 or 48 weeks (RGT). Response-guided therapy was based on early treatment success (HCV RNA <25 IU/mL at week 4 and <25 IU/mL undetected at week 8). Treatment-experienced patients received 240 mg q.d. for 24 weeks, plus PegIFNα-2b/RBV RGT (24 or 48 weeks, prior relapsers, n = 29) or PegIFNα-2b/RBV (48 weeks, 5 prior partial responders/breakthroughs, 10 prior null responders). The primary objective was safety; sustained virologic response 12 weeks post-treatment (SVR12) was a secondary end-point. All except one patient experienced drug-related adverse events. Adverse events led to faldaprevir discontinuation in 1 (2%), 13 (20%), and 3 (6.8%) patients on faldaprevir 120 mg, faldaprevir 240 mg 12 weeks, and faldaprevir 240 mg 24 weeks, respectively. The SVR12 rates were: 86% with faldaprevir 120 mg and 74% with faldaprevir 240 mg among treatment-naïve patients; and 86%, 60%, and 40% among prior relapsers, partial responders/breakthroughs, and null responders, respectively. In treatment-naïve Japanese patients, faldaprevir 120 mg q.d. plus PegIFNα-2b/RBV was better tolerated than faldaprevir 240 mg q.d. plus PegIFNα-2b/RBV, with at least comparable efficacy. In treatment-experienced patients, most prior relapsers achieved SVR12 with 24 weeks of faldaprevir 240 mg q.d. plus PegIFNα-2b/RBV. Clinicaltrials.gov NCT01579474. © 2016 The Japan Society of Hepatology.

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