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Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection.

Authors
  • Naganuma, Atsushi1
  • Chayama, Kazuaki2
  • Notsumata, Kazuo3
  • Gane, Edward4
  • Foster, Graham R5
  • Wyles, David6
  • Kwo, Paul7
  • Crown, Eric8
  • Bhagat, Abhi8
  • Mensa, Federico J8
  • Otani, Tetsuya8
  • Larsen, Lois8
  • Burroughs, Margaret8
  • Kumada, Hiromitsu9
  • 1 Department of Gastroenterology, Takasaki General Medical Center, National Hospital Organization, 36 Takamatsu-cho, Takasaki-shi, Gunma, 370-0829, Japan. [email protected] , (Japan)
  • 2 Hiroshima University Hospital, Hiroshima, Japan. , (Japan)
  • 3 Fukuiken Saiseikai Hospital, Fukui, Japan. , (Japan)
  • 4 Liver Unit, Auckland City Hospital, Auckland, New Zealand. , (New Zealand)
  • 5 Queen Mary University of London, Barts Health, London, UK.
  • 6 Denver Health Division of Infectious Diseases, University of Colorado, Denver, CO, USA.
  • 7 Division of Gastroenterology and Hepatology, Stanford University, Palo Alto, CA, USA.
  • 8 AbbVie Inc., North Chicago, IL, USA.
  • 9 Toranomon Hospital, Tokyo, Japan. , (Japan)
Type
Published Article
Journal
Journal of gastroenterology
Publication Date
Aug 01, 2019
Volume
54
Issue
8
Pages
752–761
Identifiers
DOI: 10.1007/s00535-019-01569-7
PMID: 30868245
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Chronic hepatitis C virus (HCV) infection with genotypes (GT) 1 and 2 accounts for over 50% of HCV infections globally, including over 97% of all HCV infections in Japan. Here, we report an integrated analysis of efficacy and safety of 8-week treatment with the all-oral, fixed-dose combination of the direct acting antivirals (DAA), glecaprevir and pibrentasvir (G/P), in DAA-naïve Japanese and overseas patients without cirrhosis and with HCV GT1 or GT2 infection. Data from 899 DAA-naïve patients without cirrhosis and with HCV GT1 or GT2 infection treated with G/P (300/120 mg) for 8 weeks in the six Phase 2 or 3 overseas or Japan-only clinical trials were included. All patients who received ≥ 1 dose of G/P were included in an intent-to-treat (ITT) analysis. The objectives were to evaluate rate of sustained virologic response 12 weeks post-treatment (SVR12) and safety of the 8-week regimen in the ITT population. Overall, SVR12 was achieved by 98.9% (889/899) of DAA-naïve patients without cirrhosis, including 99.2% (597/602) of GT1-infected and 98.3% (292/297) of GT2-infected patients. Less than 1% (2/899) of patients overall and no Japanese patients experienced virologic failure. SVR12 rate was > 97% for patients regardless of baseline characteristics, and common comorbidities or co-medications. Overall, < 1% (2/899) discontinued G/P due to an adverse event (AE) and 1.6% (14/899) of patients experienced a serious AE. 8-week G/P treatment is safe and efficacious in DAA-naive patients without cirrhosis and with HCV GT1 or GT2 infection, demonstrating high SVR12 rates regardless of baseline patient and disease characteristics. CLINICALTRIALS. The trials discussed in this paper were registered with ClinicalTrials.gov as follows: NCT02707952 (CERTAIN-1), NCT02723084 (CERTAIN-2), NCT02243280 (SURVEYOR-I), NCT02243293 (SURVEYOR-II), NCT02604017 (ENDURANCE-1), NCT02738138 (EXPEDITION-2).

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