Hidenori Toyoda1, Masanori Atsukawa2, Tsunamasa Watanabe3, Makoto Nakamuta4, Haruki Uojima5, Akito Nozaki6, Koichi Takaguchi7, Shinichi Fujioka8, Etsuko Iio9, Toshihide Shima10, Takehiro Akahane11, Shinya Fukunishi12, Toru Asano13, Kojiro Michitaka14, Kunihiko Tsuji15, Hiroshi Abe16, Shigeru Mikami17, Hironao Okubo18, Tomomi Okubo19, Noritomo Shimada20, Toru Ishikawa21, Akio Moriya22, Joji Tani23, Asahiro Morishita24, Chikara Ogawa25, Yoshihiko Tachi26, Hiroki Ikeda3, Naoki Yamashita4, Satoshi Yasuda1, Makoto Chuma6, Akemi Tsutsui7, Atsushi Hiraoka14, Tadashi Ikegami27, Takuya Genda28, Akihito Tsubota29, Tsutomu Masaki24, Yasuhito Tanaka9, Katsuhiko Iwakiri2, Takashi Kumada30. 1. Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Ogaki, Japan. 2. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan. 3. Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan. 4. Department of Hepatology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan. 5. Department of Gastroenterology, Internal Medicine, Kitasato University School of Medicine, Sagamihara, Japan. 6. Gastroenterology Center, Yokohama City University Medical Center, Yokohama, Japan. 7. Department of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan. 8. Department of Gastroenterology, Okayama Saiseikai General Hospital, Okayama, Japan. 9. Department of Virology and Liver Unit, Nagoya City University, Graduate School of Medical Sciences, Nagoya, Japan. 10. Department of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Suita, Japan. 11. Department of Gastroenterology, Japanese Red Cross Ishinomaki Hospital, Ishinomaki, Japan. 12. Second Department of Internal Medicine, Osaka Medical College, Osaka, Japan. 13. Department of Internal Medicine, Division of Gastroenterology and Hepatology,, Metropolitan Bokuto Hospital, Tokyo, Japan. 14. Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan. 15. Center for Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan. 16. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Shinmatusdo Central General Hospital, Matsudo, Japan. 17. Division of Gastroenterology, Department of Internal Medicine,, Kikkoman General Hospital, Noda, Japan. 18. Department of Gastroenterology, Juntendo University Nerima Hospital, Tokyo, Japan. 19. Division of Gastroenterology, Department of Internal Medicine,, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Japan. 20. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Otakanomori Hospital, Kashiwa, Japan. 21. Department of Hepatology, Saiseikai Niigata Hospital, Niigata, Japan. 22. Department of Gastroenterology, Mitoyo General Hospital, Kannonji, Japan. 23. Department of Internal Medicine, Yashima General Hospital, Takamatsu, Japan. 24. Department of Gastroenterology, Kagawa University School of Medicine, Takamatsu, Japan. 25. Department of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital, Takamatsu, Japan. 26. Department of Gastroenterology and Hepatology, Komaki City Hospital, Komaki, Japan. 27. Department of Gastroenterology, Tokyo Medical University Ibaraki Medical Center, Ibaraki, Japan. 28. Department of Gastroenterology, Juntendo University Shizuoka Hospital, Mishima, Japan. 29. Core Research Facilities for Basic Science, Jikei University School of Medicine, Tokyo, Japan. 30. Department of Nursing, Gifu Kyoritsu University, Ogaki, Japan.
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.
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.
Authors: Lisa Steininger; David Chromy; David Bauer; Benedikt Simbrunner; Teresa Binter; Philipp Schwabl; Caroline Schmidbauer; Michael Trauner; Michael Gschwantler; Mattias Mandorfer; Thomas Reiberger Journal: Wien Klin Wochenschr Date: 2020-12-22 Impact factor: 1.704