Chang, Te ShengTe ShengChangHuang, Chung FengChung FengHuangKuo, Hsing TaoHsing TaoKuoLo, Ching ChuChing ChuLoHuang, Chien WeiChien WeiHuangChong, Lee WonLee WonChongCheng, Pin NanPin NanChengYeh, Ming LunMing LunYehPeng, Cheng YuanCheng YuanPengCheng, Chien YuChien YuChengHuang, Jee FuJee FuHuangBair, Ming JongMing JongBairLin, Chih LangChih LangLinYang, Chi ChiehChi ChiehYangWang, Szu JenSzu JenWangHsieh, Tsai YuanTsai YuanHsiehLee, Tzong HsiTzong HsiLeeLee, Pei LunPei LunLeeWu, Wen ChihWen ChihWuLin, Chih LinChih LinLinSu, Wei WenWei WenSuYang, Sheng ShunSheng ShunYangCHIA-CHI WANGHu, Jui TingJui TingHuMo, Lein RayLein RayMoCHUN-TING CHENHuang, Yi HsiangYi HsiangHuangChang, Chun ChaoChun ChaoChangHuang, Chia ShengChia ShengHuangChen, Guei YingGuei YingChenKao, Chien NengChien NengKaoTai, Chi MingChi MingTaiCHUN-JEN LIULee, Mei HsuanMei HsuanLeeTsai, Pei ChienPei ChienTsaiDai, Chia YenChia YenDaiJIA-HORNG KAOLin, Han ChiehHan ChiehLinChuang, Wang LongWang LongChuangChen, Chi YiChi YiChenTseng, Kuo ChihKuo ChihTsengHung, Chao HungChao HungHungYu, Ming LungMing LungYu2023-06-262023-06-262023-06-0119360533https://scholars.lib.ntu.edu.tw/handle/123456789/633102Background: Large-scale real-world data of the 8-week glecaprevir/pibrentasvir (GLE/PIB) therapy for treatment-naïve patients of chronic hepatitis C virus (HCV) infection with compensated cirrhosis is scarce. Methods: The TASL HCV Registry (TACR) is an ongoing nationwide registry program that aims to set up a database and biobank of patients with chronic HCV infection in Taiwan. In this study, data were analyzed as of 31 October 2021 for treatment-naïve HCV patients with compensated cirrhosis receiving 8-week GLE/PIB therapy. Effectiveness reported as sustained virologic response at off-therapy week 12 (SVR12) and safety profiles were assessed. Patient characteristics potentially related to SVR12 were also evaluated. Results: Of the 301 patients enrolled, 275 had available SVR12 data. The SVR12 rate was 98.2% (270/275) in the modified intention-to-treat (mITT) population and 89.7% (270/301) in the ITT population. For those mITT patients with genotype 3, FibroScan > 20 kPa, platelet < 150,000/µl, and FibroScan > 20 kPa and platelet < 150,000/µl, the SVR12 rates were 100% (6/6), 100% (12/12), 98.0% (144/147), 100% (7/7), respectively. Overall, 24.9% (75/301) patients experienced adverse events (AEs). The most frequent AEs (> 5%) included fatigue (9.0%) and pruritus (7.0%). Seven (2.3%) patients experienced serious AEs and two (0.7%) resulted in permanent drug discontinuation. None of them were considered as GLE/PIB-related. Conclusions: In this large-scale real-world Taiwanese cohort, 8-week GLE/PIB therapy was efficacious and well tolerated for treatment-naïve compensated cirrhosis patients. SVR12 rates were similarly high as in the clinical trials, including those with characteristics of advanced liver disease.enCompensated cirrhosis | GLE/PIB | HCV | Sustained virologic responsejournal article10.1007/s12072-023-10506-z369736332-s2.0-85150983333WOS:000961490100001https://api.elsevier.com/content/abstract/scopus_id/85150983333