Real‐world experience of 12‐week direct‐acting antiviral regimen of glecaprevir and pibrentasvir in patients with chronic hepatitis C virus infection. Issue 5 (19th November 2019)

• Record Type: Journal Article
• Authors: Toyoda, Hidenori; Atsukawa, Masanori; Watanabe, Tsunamasa; Nakamuta, Makoto; Uojima, Haruki; Nozaki, Akito; Takaguchi, Koichi; Fujioka, Shinichi; Iio, Etsuko; Shima, Toshihide; Akahane, Takehiro; Fukunishi, Shinya; Asano, Toru; Michitaka, Kojiro; Tsuji, Kunihiko; Abe, Hiroshi; Mikami, Shigeru; Okubo, Hironao; Okubo, Tomomi; Shimada, Noritomo; Ishikawa, Toru; Moriya, Akio; Tani, Joji; Morishita, Asahiro; Ogawa, Chikara; Tachi, Yoshihiko; Ikeda, Hiroki; Yamashita, Naoki; Yasuda, Satoshi; Chuma, Makoto; Tsutsui, Akemi; Hiraoka, Atsushi; Ikegami, Tadashi; Genda, Takuya; Tsubota, Akihito; Masaki, Tsutomu; Tanaka, Yasuhito; Iwakiri, Katsuhiko; Kumada, Takashi;
• Is Part Of: Journal of gastroenterology and hepatology. Volume 35:Issue 5(2020)
• Page Start: 855
• Page End: 861
• Publication Date: 2019-11-19
• Subjects: glecaprevir -- hepatitis C virus -- pibrentasvir -- real world -- sustained virological response -- tolerability; Gastroenterology -- Periodicals; Digestive organs -- Diseases -- Periodicals; Liver -- Diseases -- Periodicals; Gastroenterology -- Periodicals; Liver Diseases -- Periodicals; 616.33
• DOI: 10.1111/jgh.14874
• Languages: English
• ISSNs: 0815-9319

Abstract

Abstract: 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.