PMID- 31710759 OWN - NLM STAT- MEDLINE DCOM- 20210621 LR - 20221207 IS - 1478-3231 (Electronic) IS - 1478-3223 (Linking) VI - 40 IP - 4 DP - 2020 Apr TI - Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection: Real-world effectiveness and safety in Taiwan. PG - 758-768 LID - 10.1111/liv.14295 [doi] AB - BACKGROUND & AIMS: Large-scale data regarding the real-world effectiveness and safety of glecaprevir/pibrentasvir (GLE/PIB) for patients with chronic hepatitis C virus (HCV) infection were limited in East Asia. We aimed to evaluate the clinical performance of GLE/PIB in different HCV populations in Taiwan. METHODS: A total of 658 chronic HCV patients with compensated liver diseases receiving GLE/PIB for 8 (n = 549), 12 (n = 103) or 16 (n = 6) weeks were retrospectively enrolled. The effectiveness was determined by sustained virologic response at off-therapy 12 weeks (SVR(12) ). Patient characteristics potentially related to SVR(12) and the safety profiles were also assessed. RESULTS: By evaluable population (EP) and per-protocol (PP) analyses, the overall SVR(12) rate was 98.2% (95% confidence interval (CI): 96.8%-99.0%) and 99.4% (95% CI: 98.4%-99.8%). The SVR(12) rates were 98.9% (95% CI: 97.6%-99.5%), 94.2% (95% CI: 87.9%-97.3%) and 100% (95% CI: 60.1%-100%) in patients receiving 8, 12 and 16 weeks of treatment respectively. A total of 656 (99.7%) patients completed the scheduled treatment. The SVR(12) rates were comparable regardless of baseline characteristics or week 4 viral decline. Twenty (3.0%) patients had serious adverse events (AEs), but none were not related to GLE/PIB. The two most common AEs were pruritus (7.8%) and fatigue (5.5%). Two (0.3%) and no patients had >/=3-fold upper limit of normal (ULN) for total bilirubin and alanine aminotransferase (ALT) levels. CONCLUSIONS: GLE/PIB for 8-16 weeks is effective and well-tolerated for patients with chronic HCV infection in Taiwan. CI - (c) 2019 John Wiley & Sons A/S. Published by 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 - 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 - Hung, Chien-Ching AU - Hung CC AUID- ORCID: 0000-0001-7345-0836 AD - Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. AD - Department of Tropical Medicine and Parasitology, National Taiwan University College of Medicine, Taipei, Taiwan. FAU - Hsieh, Szu-Min AU - Hsieh SM AD - Department of Internal Medicine, National Taiwan University Hospital, 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 - Sun, Hsin-Yun AU - Sun HY AD - Department of Internal Medicine, 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 - 20191111 PL - United States TA - Liver Int JT - Liver international : official journal of the International Association for the Study of the Liver JID - 101160857 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 MH - Antiviral Agents/adverse effects MH - Benzimidazoles MH - Cyclopropanes MH - Asia, Eastern MH - Genotype MH - Hepacivirus/genetics MH - *Hepatitis C, Chronic/drug therapy MH - Humans MH - Lactams, Macrocyclic MH - Leucine/analogs & derivatives MH - Proline/analogs & derivatives MH - Pyrrolidines MH - Quinoxalines MH - Retrospective Studies MH - Sulfonamides MH - Taiwan OTO - NOTNLM OT - direct acting antiviral agent OT - glecaprevir OT - hepatitis C virus OT - pibrentasvir EDAT- 2019/11/12 06:00 MHDA- 2021/06/22 06:00 CRDT- 2019/11/12 06:00 PHST- 2019/09/03 00:00 [received] PHST- 2019/10/09 00:00 [revised] PHST- 2019/10/28 00:00 [accepted] PHST- 2019/11/12 06:00 [pubmed] PHST- 2021/06/22 06:00 [medline] PHST- 2019/11/12 06:00 [entrez] AID - 10.1111/liv.14295 [doi] PST - ppublish SO - Liver Int. 2020 Apr;40(4):758-768. doi: 10.1111/liv.14295. Epub 2019 Nov 11.