1. Real‐world experience of 12‐week direct‐acting antiviral regimen of glecaprevir and pibrentasvir in patients with chronic hepatitis C virus infection
- Author
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Toshihide Shima, Shigeru Mikami, Etsuko Iio, Tadashi Ikegami, Yasuhito Tanaka, Shinichi Fujioka, Takashi Kumada, Akio Moriya, Akihito Tsubota, Hiroshi Abe, Toru Asano, Akito Nozaki, Hiroki Ikeda, Takehiro Akahane, Joji Tani, Kojiro Michitaka, Kunihiko Tsuji, Toru Ishikawa, Satoshi Yasuda, Naoki Yamashita, Takuya Genda, Akemi Tsutsui, Chikara Ogawa, Koichi Takaguchi, Tsunamasa Watanabe, Yoshihiko Tachi, Masanori Atsukawa, Shinya Fukunishi, Asahiro Morishita, Tomomi Okubo, Makoto Nakamuta, Makoto Chuma, Tsutomu Masaki, Haruki Uojima, Atsushi Hiraoka, Hironao Okubo, Hidenori Toyoda, Katsuhiko Iwakiri, and Noritomo Shimada
- Subjects
Adult ,Male ,medicine.medical_specialty ,Pyrrolidines ,Time Factors ,Sustained Virologic Response ,Hepatitis C virus ,medicine.disease_cause ,Antiviral Agents ,Cohort Studies ,03 medical and health sciences ,0302 clinical medicine ,Japan ,Quinoxalines ,Internal medicine ,Humans ,Medicine ,Prospective Studies ,Prospective cohort study ,Adverse effect ,Aged ,Sulfonamides ,Hepatology ,business.industry ,Gastroenterology ,Glecaprevir ,Hepatitis C, Chronic ,Middle Aged ,Pibrentasvir ,Clinical trial ,Drug Combinations ,Regimen ,Treatment Outcome ,Tolerability ,030220 oncology & carcinogenesis ,Benzimidazoles ,Female ,030211 gastroenterology & hepatology ,business ,Follow-Up Studies - 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-naive, non-cirrhotic, non-genotype 3 patients who underwent 8-week regimen.
- Published
- 2019