TY - JOUR
T1 - Real-world experience of 12-week direct-acting antiviral regimen of glecaprevir and pibrentasvir in patients with chronic hepatitis C virus infection
AU - Toyoda, Hidenori
AU - Atsukawa, Masanori
AU - Watanabe, Tsunamasa
AU - Nakamuta, Makoto
AU - Uojima, Haruki
AU - Nozaki, Akito
AU - Takaguchi, Koichi
AU - Fujioka, Shinichi
AU - Iio, Etsuko
AU - Shima, Toshihide
AU - Akahane, Takehiro
AU - Fukunishi, Shinya
AU - Asano, Toru
AU - Michitaka, Kojiro
AU - Tsuji, Kunihiko
AU - Abe, Hiroshi
AU - Mikami, Shigeru
AU - Okubo, Hironao
AU - Okubo, Tomomi
AU - Shimada, Noritomo
AU - Ishikawa, Toru
AU - Moriya, Akio
AU - Tani, Joji
AU - Morishita, Asahiro
AU - Ogawa, Chikara
AU - Tachi, Yoshihiko
AU - Ikeda, Hiroki
AU - Yamashita, Naoki
AU - Yasuda, Satoshi
AU - Chuma, Makoto
AU - Tsutsui, Akemi
AU - Hiraoka, Atsushi
AU - Ikegami, Tadashi
AU - Genda, Takuya
AU - Tsubota, Akihito
AU - Masaki, Tsutomu
AU - Tanaka, Yasuhito
AU - Iwakiri, Katsuhiko
AU - Kumada, Takashi
N1 - Publisher Copyright:
© 2019 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd
PY - 2020/5/1
Y1 - 2020/5/1
N2 - Background: In clinical trials, a pangenotype direct-acting antiviral (DAA) regimen consisting of glecaprevir (GLE) and pibrentasvir (PIB) exhibited high virologic efficacy and tolerability in patients with hepatitis C virus (HCV) infection. This study sought to confirm these findings in real-world settings, focusing on patients with cirrhosis, history of DAA failure, or HCV genotype 3 who were treated with a 12-week regimen in a large multicenter study from Japan. Methods: In a nationwide multicenter prospective cohort study, we analyzed background characteristics, tolerability, and treatment outcome of patients who underwent a 12-week GLE/PIB regimen. Results: Of 1190 patients, 509 (42.8%) underwent the 12-week regimen, and the remaining patients underwent an 8-week regimen. The rate of sustained virologic response (SVR) of patients treated with the 12-week regimen was 99.0%, comparable with that of patients treated with the 8-week regimen. The adverse events were observed in 29.1% of patients. The main adverse event was pruritus, which was observed in 14.7%. Ten patients (2.0%) discontinued therapy during treatment period. Conclusion: The 12-week GLE/PIB regimen was well-tolerated with high virologic efficacy in patients with cirrhosis, experience of DAA, or HCV genotype 3; tolerability and SVR rate were comparable with those of DAA-naïve, non-cirrhotic, non-genotype 3 patients who underwent 8-week regimen.
AB - Background: In clinical trials, a pangenotype direct-acting antiviral (DAA) regimen consisting of glecaprevir (GLE) and pibrentasvir (PIB) exhibited high virologic efficacy and tolerability in patients with hepatitis C virus (HCV) infection. This study sought to confirm these findings in real-world settings, focusing on patients with cirrhosis, history of DAA failure, or HCV genotype 3 who were treated with a 12-week regimen in a large multicenter study from Japan. Methods: In a nationwide multicenter prospective cohort study, we analyzed background characteristics, tolerability, and treatment outcome of patients who underwent a 12-week GLE/PIB regimen. Results: Of 1190 patients, 509 (42.8%) underwent the 12-week regimen, and the remaining patients underwent an 8-week regimen. The rate of sustained virologic response (SVR) of patients treated with the 12-week regimen was 99.0%, comparable with that of patients treated with the 8-week regimen. The adverse events were observed in 29.1% of patients. The main adverse event was pruritus, which was observed in 14.7%. Ten patients (2.0%) discontinued therapy during treatment period. Conclusion: The 12-week GLE/PIB regimen was well-tolerated with high virologic efficacy in patients with cirrhosis, experience of DAA, or HCV genotype 3; tolerability and SVR rate were comparable with those of DAA-naïve, non-cirrhotic, non-genotype 3 patients who underwent 8-week regimen.
KW - glecaprevir
KW - hepatitis C virus
KW - pibrentasvir
KW - real world
KW - sustained virological response
KW - tolerability
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U2 - 10.1111/jgh.14874
DO - 10.1111/jgh.14874
M3 - Article
C2 - 31609495
AN - SCOPUS:85075319174
SN - 0815-9319
VL - 35
SP - 855
EP - 861
JO - Journal of Gastroenterology and Hepatology (Australia)
JF - Journal of Gastroenterology and Hepatology (Australia)
IS - 5
ER -