Evaluation of 8-week glecaprevir/pibrentasvir treatment in direct-acting antiviral-naïve noncirrhotic HCV genotype 1 and 2infected patients in a real-world setting in Japan

Hiroki Ikeda, Tsunamasa Watanabe, Masanori Atsukawa, Hidenori Toyoda, Koichi Takaguchi, Makoto Nakamuta, Nobuyuki Matsumoto, Chiaki Okuse, Toshifumi Tada, Akemi Tsutsui, Naoki Yamashita, Chisa Kondo, Korenobu Hayama, Keizo Kato, Norio Itokawa, Taeang Arai, Noritomo Shimada, Toru Asano, Haruki Uojima, Chikara OgawaShigeru Mikami, Tadashi Ikegami, Shinya Fukunishi, Akira Asai, Etsuko Iio, Akihito Tsubota, Atsushi Hiraoka, Akito Nozaki, Hironao Okubo, Yoshihiko Tachi, Akio Moriya, Tsunekazu Oikawa, Yoshihiro Matsumoto, Shuichi Tsuruoka, Joji Tani, Kan Kikuchi, Katsuhiko Iwakiri, Yasuhito Tanaka, Takashi Kumada

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4 Citations (Scopus)

Abstract

Based on high efficacy and safety demonstrated in clinical trials, treatment with glecaprevir/pibrentasvir (G/P) for 8 weeks is recommended for hepatitis C virus (HCV)–infected patients who are direct-acting antiviral (DAA) naïve, genotype 1 or 2, and noncirrhotic. The aim of this study was to validate real-world experience with 8-week G/P treatment in Japan. We conducted a prospective observational cohort study in 554 patients who underwent 8-week treatment from among 1,022 patients who initiated G/P therapy. The majority (54.5%) were male, with a median age of 66 years, and HCV genotype distribution was genotype 1, 43.8%; genotype 2, 55.3%; and mixed subtype, 0.9%. Overall, the sustained virologic response rate at 12 weeks (SVR12) was 92.8% (530/571) in the intention-to-treat population and 99.3% (526/530) in the per-protocol population. The SVR12 rates by subgroups were as follows: subtype 1a, 100% (6/6); 1b, 100% (189/189); 2a, 99.3% (150/151); 2b, 99.0% (103/104); and mixed subtype, 50% (2/4). Among four patients with virologic failure following 8-week treatment with G/P, none had baseline polymorphisms or treatment-emergent amino acid substitutions in NS3. However, 2 of 4 patients with virologic failure had treatment-emergent amino acid substitutions in NS5A. Adverse events (AEs) were reported in 21.5% of patients and 1.2% of patients discontinued due to drug-related AEs. In conclusion, G/P treatment for 8 weeks was safe and effective for DAA-naïve noncirrhotic genotype 1 or 2 patients in a real-world clinical setting in Japan.

Original languageEnglish
Pages (from-to)1266-1275
Number of pages10
JournalJournal of Viral Hepatitis
Volume26
Issue number11
DOIs
Publication statusPublished - 01-11-2019

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Infectious Diseases
  • Virology

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    Ikeda, H., Watanabe, T., Atsukawa, M., Toyoda, H., Takaguchi, K., Nakamuta, M., Matsumoto, N., Okuse, C., Tada, T., Tsutsui, A., Yamashita, N., Kondo, C., Hayama, K., Kato, K., Itokawa, N., Arai, T., Shimada, N., Asano, T., Uojima, H., ... Kumada, T. (2019). Evaluation of 8-week glecaprevir/pibrentasvir treatment in direct-acting antiviral-naïve noncirrhotic HCV genotype 1 and 2infected patients in a real-world setting in Japan. Journal of Viral Hepatitis, 26(11), 1266-1275. https://doi.org/10.1111/jvh.13170