PMID- 31981264 OWN - NLM STAT- MEDLINE DCOM- 20210809 LR - 20210809 IS - 1365-2893 (Electronic) IS - 1352-0504 (Linking) VI - 27 IP - 6 DP - 2020 Jun TI - Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection and severe renal impairment. PG - 568-575 LID - 10.1111/jvh.13265 [doi] AB - Data are limited regarding the real-world effectiveness and safety of glecaprevir/pibrentasvir (GLE/PIB) in patients with chronic hepatitis C virus (HCV) infection and severe renal impairment (RI). We aimed to evaluate the performance of GLE/PIB in patients with chronic kidney disease (CKD) stage 4 or 5 in Taiwan. 108 chronic HCV patients with CKD stage 4 (n = 32) or 5 (n = 76) receiving GLE/PIB for 8-12 weeks were retrospectively recruited at 4 academic centres in Taiwan. The effectiveness was determined by sustained virologic response at off-therapy week 12 (SVR(12) ) for evaluable (EP) and per-protocol populations (PP). The safety profiles were also assessed. By EP and PP analyses, the SVR(12) rate was 99.1% (107 of 108 patients; 95% confidence interval (CI): 94.9%-99.8%) and 100% (107 of 107 patients; 95% CI: 96.5%-100%). The SVR(12) rates were 100% (95% CI: 89.3%-100%) and 98.7% (95% CI: 92.9%-99.8%) in patients with CKD stage 4 and 5, respectively. One patient, who declined off-therapy follow-up after permanently discontinuing GLE/PIB at on-treatment week 9 due to scheduled cardiac surgery, had nonvirologic failure. Sixteen (14.8%) patients had serious adverse events (AEs), which were judged not related to GLE/PIB. The three most common AEs were pruritus (19.4%), fatigue (15.7%) and nausea (13.9%). None had >/=3-fold upper limit of normal for total bilirubin and alanine aminotransferase levels. None of the 9 patients with hepatitis B virus (HBV) coinfection developed HBV-associated hepatitis. In conclusion, GLE/PIB for 8-12 weeks is effective and well-tolerated in HCV patients with severe RI. CI - (c) 2020 John Wiley & Sons Ltd. FAU - Liu, Chen-Hua AU - Liu CH AUID- ORCID: 0000-0003-3622-9707 AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. AD - Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Douliou, Taiwan. FAU - Yang, Sheng-Shun AU - Yang SS AD - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan. AD - School of Medicine, Chung Shan Medical University, Taichung, Taiwan. AD - Rong Hsing Research Center for Translational Medicine, National Chung Hsing University, Taipei, Taiwan. AD - Ph.D. Program in Translational Medicine, National Chung Hsing University, Taichung, Taiwan. AD - Institute of Biomedical Sciences, National Chung Hsing University, Taichung, Taiwan. FAU - Peng, Cheng-Yuan AU - Peng CY AUID- ORCID: 0000-0001-9030-6086 AD - Center for Digestive Medicine, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan. AD - School of Medicine, China Medical University, Taichung, Taiwan. FAU - Lin, Woan-Tyy AU - Lin WT AD - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan. FAU - Liu, Chun-Jen AU - Liu CJ AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. AD - Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan. FAU - Su, Tung-Hung AU - Su TH AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. FAU - Tseng, Tai-Chung AU - Tseng TC AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. FAU - Chen, Pei-Jer AU - Chen PJ AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. AD - Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan. FAU - Chen, Ding-Shinn AU - Chen DS AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. AD - Genomics Research Center, Academia Sinica, Taipei, Taiwan. FAU - Kao, Jia-Horng AU - Kao JH AUID- ORCID: 0000-0002-2442-7952 AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. AD - Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan. LA - eng PT - Journal Article DEP - 20200206 PL - England TA - J Viral Hepat JT - Journal of viral hepatitis JID - 9435672 RN - 0 (Aminoisobutyric Acids) RN - 0 (Antiviral Agents) RN - 0 (Benzimidazoles) RN - 0 (Cyclopropanes) RN - 0 (Lactams, Macrocyclic) RN - 0 (Pyrrolidines) RN - 0 (Quinoxalines) RN - 0 (Sulfonamides) RN - 2WU922TK3L (pibrentasvir) RN - 9DLQ4CIU6V (Proline) RN - GMW67QNF9C (Leucine) RN - K6BUU8J72P (glecaprevir) SB - IM MH - Aminoisobutyric Acids/*therapeutic use MH - Antiviral Agents/*therapeutic use MH - Benzimidazoles/*therapeutic use MH - Cyclopropanes/*therapeutic use MH - Genotype MH - Hepacivirus MH - *Hepatitis C, Chronic/drug therapy MH - Humans MH - Lactams, Macrocyclic/*therapeutic use MH - Leucine/*analogs & derivatives/therapeutic use MH - Proline/*analogs & derivatives/therapeutic use MH - Pyrrolidines/*therapeutic use MH - Quinoxalines/*therapeutic use MH - Renal Insufficiency, Chronic/*complications MH - Retrospective Studies MH - Sulfonamides/*therapeutic use MH - Sustained Virologic Response MH - Taiwan OTO - NOTNLM OT - chronic kidney disease OT - direct-acting antiviral agent OT - glecaprevir OT - hepatitis C virus OT - pibrentasvir EDAT- 2020/01/26 06:00 MHDA- 2021/08/10 06:00 CRDT- 2020/01/26 06:00 PHST- 2019/10/13 00:00 [received] PHST- 2020/01/02 00:00 [revised] PHST- 2020/01/03 00:00 [accepted] PHST- 2020/01/26 06:00 [pubmed] PHST- 2021/08/10 06:00 [medline] PHST- 2020/01/26 06:00 [entrez] AID - 10.1111/jvh.13265 [doi] PST - ppublish SO - J Viral Hepat. 2020 Jun;27(6):568-575. doi: 10.1111/jvh.13265. Epub 2020 Feb 6.