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Real-world virological efficacy and safety of daclatasvir/asunaprevir/beclabuvir in patients with chronic hepatitis C virus genotype 1 infection in Japan

  • Koichi TakaguchiEmail author
  • Hidenori Toyoda
  • Akemi Tsutsui
  • Yoshiyuki Suzuki
  • Makoto Nakamuta
  • Michio Imamura
  • Tomonori Senoh
  • Takuya Nagano
  • Toshifumi Tada
  • Yoshihiko Tachi
  • Atsushi Hiraoka
  • Kojiro Michitaka
  • Hiroshi Shibata
  • Kouji Joko
  • Hironao Okubo
  • Kunihiko Tsuji
  • Shintaro Takaki
  • Tsunamasa Watanabe
  • Chikara Ogawa
  • Kazuaki Chayama
  • Takashi Kumada
  • Masatoshi Kudo
  • Hiromitsu Kumada
Original Article—Liver, Pancreas, and Biliary Tract

Abstract

Background

The virological efficacy and safety of the direct-acting antiviral (DAA) regimen consisting of daclatasvir, asunaprevir, and beclabuvir (DCV/ASV/BCV) for patients chronically infected with hepatitis C virus (HCV) genotype 1 have not been previously evaluated in Japanese real-world settings.

Methods

In a Japanese nationwide multicenter study, the rate of sustained virologic response (SVR) and safety were analyzed in 91 patients who started the DCV/ASV/BCV regimen between November 2016 and July 2017. SVR rates were compared based on baseline patient characteristics.

Results

More than 60% of patients had a history of failure to achieve SVR with interferon (IFN)-free DAA therapy. Overall, 50 of 91 patients (54.9%) achieved SVR. Multivariate analysis identified a history of failure with IFN-free DAA therapy and pretreatment HCV RNA levels as factors significantly associated with treatment failure. Whereas the SVR rate in patients without a history of IFN-free DAA therapy was 91.7% (33 of 36 patients), it was only 30.9% (17 of 55 patients) among patients with a history of IFN-free DAA therapy. The rate of discontinuation due to an adverse event was 4.4%.

Conclusions

Many patients treated with the DCV/ASV/BCV regimen have a history of a failure to achieve SVR with previous IFN-free DAA therapy. SVR rate was not as high as that in pre-approval clinical trial of this regimen in IFN-free DAA-naïve patients. In addition, most patients with a history of failure with IFN-free DAA therapy, particularly the DCV/ASV regimen, showed resistance to this regimen.

Keywords

Chronic hepatitis C Real-world effectiveness Daclatasvir Asunaprevir Beclabuvir 

Notes

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Copyright information

© Japanese Society of Gastroenterology 2019

Authors and Affiliations

  • Koichi Takaguchi
    • 1
    Email author
  • Hidenori Toyoda
    • 2
  • Akemi Tsutsui
    • 1
  • Yoshiyuki Suzuki
    • 3
  • Makoto Nakamuta
    • 4
  • Michio Imamura
    • 5
  • Tomonori Senoh
    • 1
  • Takuya Nagano
    • 1
  • Toshifumi Tada
    • 2
  • Yoshihiko Tachi
    • 6
  • Atsushi Hiraoka
    • 7
  • Kojiro Michitaka
    • 7
  • Hiroshi Shibata
    • 8
  • Kouji Joko
    • 9
  • Hironao Okubo
    • 10
  • Kunihiko Tsuji
    • 11
  • Shintaro Takaki
    • 12
  • Tsunamasa Watanabe
    • 13
  • Chikara Ogawa
    • 14
  • Kazuaki Chayama
    • 5
  • Takashi Kumada
    • 2
  • Masatoshi Kudo
    • 15
  • Hiromitsu Kumada
    • 3
  1. 1.Department of HepatologyKagawa Prefectural Central HospitalTakamatsuJapan
  2. 2.Department of GastroenterologyOgaki Municipal HospitalOgakiJapan
  3. 3.Department of HepatologyToranomon HospitalTokyoJapan
  4. 4.National Hospital Organization, Kyushu Medical CenterFukuokaJapan
  5. 5.Department of Gastroenterology and Metabolism, Institute of Biomedical and Health ScienceHiroshima UniversityHiroshimaJapan
  6. 6.Department of GastroenterologyKomaki City HospitalKomakiJapan
  7. 7.Gastroenterology CenterEhime Prefectural Central HospitalMatsuyamaJapan
  8. 8.Department of GastroenterologyTokushima Prefectural Central HospitalTokushimaJapan
  9. 9.Center for Liver-Biliary-Pancreatic DiseaseMatsuyama Red Cross HospitalMatsuyamaJapan
  10. 10.Department of GastroenterologyJuntendo University Nerima HospitalTokyoJapan
  11. 11.Center of GastroenterologyTeine Keijinkai HospitalSapporoJapan
  12. 12.Department of GastroenterologyHiroshima Red Cross Hospital & Atomic-bomb Survivors HospitalHiroshimaJapan
  13. 13.Department of Internal MedicineSt. Marianna University School of MedicineKawasakiJapan
  14. 14.Department of Gastroenterology and HepatologyTakamatsu Red Cross HospitalTakamatsuJapan
  15. 15.Department of Gastroenterology and HepatologyKinki University School of MedicineOsakaJapan

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