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

Koichi Takaguchi, 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 ChayamaTakashi Kumada, Masatoshi Kudo, Hiromitsu Kumada

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6 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)742-751
Number of pages10
JournalJournal of Gastroenterology
Volume54
Issue number8
DOIs
Publication statusPublished - 05-08-2019

All Science Journal Classification (ASJC) codes

  • Gastroenterology

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    Takaguchi, K., Toyoda, H., Tsutsui, A., Suzuki, Y., Nakamuta, M., Imamura, M., Senoh, T., Nagano, T., Tada, T., Tachi, Y., Hiraoka, A., Michitaka, K., Shibata, H., Joko, K., Okubo, H., Tsuji, K., Takaki, S., Watanabe, T., Ogawa, C., ... Kumada, H. (2019). Real-world virological efficacy and safety of daclatasvir/asunaprevir/beclabuvir in patients with chronic hepatitis C virus genotype 1 infection in Japan. Journal of Gastroenterology, 54(8), 742-751. https://doi.org/10.1007/s00535-019-01568-8