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JOURNAL ARTICLE

Real-world experience of 12-week DAA regimen of glecaprevir and pibrentasvir in patients with chronic HCV infection

Hidenori Toyoda, Masanori Atsukawa, Tsunamasa Watanabe, Makoto Nakamuta, Haruki Uojima, Akito Nozaki, Koichi Takaguchi, Shinichi Fujioka, Etsuko Iio, Toshihide Shima, Takehiro Akahane, Shinya Fukunishi, Toru Asano, Kojiro Michitaka, Kunihiko Tsuji, Hiroshi Abe, Shigeru Mikami, Hironao Okubo, Tomomi Okubo, Noritomo Shimada, Toru Ishikawa, Akio Moriya, Joji Tani, Asahiro Morishita, Chikara Ogawa, Yoshihiko Tachi, Hiroki Ikeda, Naoki Yamashita, Satoshi Yasuda, Makoto Chuma, Akemi Tsutsui, Atsushi Hiraoka, Tadashi Ikegami, Takuya Genda, Akihito Tsubota, Tsutomu Masaki, Yasuhito Tanaka, Katsuhiko Iwakiri, Takashi Kumada
Journal of Gastroenterology and Hepatology 2019 October 14
31609495

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 to 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 to those of DAA-naïve, non-cirrhotic, non-genotype 3 patients who underwent 8-week regimen.

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