TY - JOUR
T1 - Real-world virological efficacy and safety of daclatasvir/asunaprevir/beclabuvir in patients with chronic hepatitis C virus genotype 1 infection in Japan
AU - Takaguchi, Koichi
AU - Toyoda, Hidenori
AU - Tsutsui, Akemi
AU - Suzuki, Yoshiyuki
AU - Nakamuta, Makoto
AU - Imamura, Michio
AU - Senoh, Tomonori
AU - Nagano, Takuya
AU - Tada, Toshifumi
AU - Tachi, Yoshihiko
AU - Hiraoka, Atsushi
AU - Michitaka, Kojiro
AU - Shibata, Hiroshi
AU - Joko, Kouji
AU - Okubo, Hironao
AU - Tsuji, Kunihiko
AU - Takaki, Shintaro
AU - Watanabe, Tsunamasa
AU - Ogawa, Chikara
AU - Chayama, Kazuaki
AU - Kumada, Takashi
AU - Kudo, Masatoshi
AU - Kumada, Hiromitsu
PY - 2019/8/5
Y1 - 2019/8/5
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85062781069&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85062781069&partnerID=8YFLogxK
U2 - 10.1007/s00535-019-01568-8
DO - 10.1007/s00535-019-01568-8
M3 - Article
C2 - 30848363
AN - SCOPUS:85062781069
VL - 54
SP - 742
EP - 751
JO - Journal of Gastroenterology
JF - Journal of Gastroenterology
SN - 0944-1174
IS - 8
ER -