Eiichi Ogawa1, Norihiro Furusyo1, Makoto Nakamuta2, Hideyuki Nomura3, Takeaki Satoh4, Kazuhiro Takahashi5, Toshimasa Koyanagi6, Eiji Kajiwara7, Kazufumi Dohmen8, Akira Kawano9, Aritsune Ooho10, Koichi Azuma11, Masaki Kato12, Shinji Shimoda13, Jun Hayashi14. 1. Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan. 2. Department of Gastroenterology, Kyushu Medical Center, National Hospital Organization, Fukuoka, Japan. 3. The Center for Liver Disease, Shin-Kokura Hospital, Kitakyushu, Japan. 4. Center for Liver Disease, National Hospital Organization Kokura Medical Center, Kitakyushu, Japan. 5. Department of Medicine, Hamanomachi Hospital, Fukuoka, Japan. 6. Department of Medicine, Fukuoka City Hospital, Fukuoka, Japan. 7. Kajiwara Clinic, Kitakyushu, Japan. 8. Department of Internal Medicine, Chihaya Hospital, Fukuoka, Japan. 9. Department of Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan. 10. Department of Hepatology, Steel Memorial Yawata Hospital, Kitakyushu, Japan. 11. Department of Medicine, Kyushu Central Hospital, Fukuoka, Japan. 12. Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 13. Department of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 14. Kyushu General Internal Medicine Center, Haradoi Hospital, Fukuoka, Japan.
Abstract
AIM: Glecaprevir (GLE) and pibrentasvir (PIB) are new direct-acting antiviral agents (DAAs) with pangenotypic inhibitors that respectively target the hepatitis C virus (HCV) NS3/4 protease and NS5A. The aim of this study was to evaluate the effectiveness and safety of combining GLE and PIB for patients with HCV genotype (GT) 1 or 2 infection in the clinical setting, including patients DAA-experienced or on hemodialysis. METHODS: This multicenter, real-world, retrospective, cohort study consisted of 314 Japanese patients who were treated with GLE (300 mg) and PIB (120 mg) for a fixed 8- or 12-week duration. We evaluated the sustained virologic response rate 12 weeks after the end of treatment (SVR12) and adverse events. RESULTS: Among the treated patients, 122 had GT1 and 192 GT2 infection. The overall SVR12 rates in the per-protocol populations were 99.2% (119/120) for GT1 and 98.9% (183/185) for GT2. High SVR12 rates were observed in almost all subgroups, including cirrhosis, receiving hemodialysis, or previous all-oral DAA groups treated with asunaprevir and daclatasvir (GT1b), ledipasvir/sofosbuvir (GT1), or sofosbuvir and ribavirin (GT2). Virological relapse occurred in only 1.0% (3/305) of the patients who completed treatment. The most common adverse events were pruritus and fatigue (>5% of patients). Serious adverse events were rare and discontinuation due to an adverse event was required for 1.6% of the patients. CONCLUSIONS: In this real-world cohort study, treatment with GLE/PIB achieved high SVR12 rates with a low rate of serious adverse events among patients with HCV GT1 or 2 infection.
AIM: Glecaprevir (GLE) and pibrentasvir (PIB) are new direct-acting antiviral agents (DAAs) with pangenotypic inhibitors that respectively target the hepatitis C virus (HCV) NS3/4 protease and NS5A. The aim of this study was to evaluate the effectiveness and safety of combining GLE and PIB for patients with HCV genotype (GT) 1 or 2 infection in the clinical setting, including patientsDAA-experienced or on hemodialysis. METHODS: This multicenter, real-world, retrospective, cohort study consisted of 314 Japanese patients who were treated with GLE (300 mg) and PIB (120 mg) for a fixed 8- or 12-week duration. We evaluated the sustained virologic response rate 12 weeks after the end of treatment (SVR12) and adverse events. RESULTS: Among the treated patients, 122 had GT1 and 192 GT2 infection. The overall SVR12 rates in the per-protocol populations were 99.2% (119/120) for GT1 and 98.9% (183/185) for GT2. High SVR12 rates were observed in almost all subgroups, including cirrhosis, receiving hemodialysis, or previous all-oral DAA groups treated with asunaprevir and daclatasvir (GT1b), ledipasvir/sofosbuvir (GT1), or sofosbuvir and ribavirin (GT2). Virological relapse occurred in only 1.0% (3/305) of the patients who completed treatment. The most common adverse events were pruritus and fatigue (>5% of patients). Serious adverse events were rare and discontinuation due to an adverse event was required for 1.6% of the patients. CONCLUSIONS: In this real-world cohort study, treatment with GLE/PIB achieved high SVR12 rates with a low rate of serious adverse events among patients with HCVGT1 or 2 infection.
Authors: Young Joo Park; Hyun Young Woo; Jeong Heo; Sang Gyu Park; Young Mi Hong; Ki Tae Yoon; Dong Uk Kim; Gwang Ha Kim; Hyung Hoi Kim; Geun Am Song; Mong Cho Journal: Gut Liver Date: 2021-05-15 Impact factor: 4.519