PMID- 31279502
OWN - NLM
STAT- MEDLINE
DCOM- 20200115
LR  - 20211204
IS  - 0929-6646 (Print)
IS  - 0929-6646 (Linking)
VI  - 118
IP  - 8
DP  - 2019 Aug
TI  - Real-world effectiveness and safety of glecaprevir/pibrentasvir in Asian patients 
      with chronic hepatitis C.
PG  - 1187-1192
LID - S0929-6646(19)30532-7 [pii]
LID - 10.1016/j.jfma.2019.06.014 [doi]
AB  - BACKGROUND: Glecaprevir/pibrentasvir (GLE/PIB) is a pangenotypic direct-acting 
      antiviral agent for the treatment of chronic hepatitis C virus (HCV) infection. 
      Real-world data of GLE/PIB in Asian patients other than Japanese are limited. We 
      thus investigated the effectiveness and safety profile of GLE/PIB in Taiwanese 
      patients with chronic hepatitis C (CHC). METHODS: CHC patients who received 8, 
      12, or 16 weeks of GLE/PIB between August and October of 2018 were consecutively 
      enrolled. The treatment duration was determined according to drug label. The 
      hepatic fibrosis was staged according to liver histology, transient elastography, 
      fibrosis index based on 4 factors (FIB-4), or findings of 
      ultrasonography/endoscopy. The primary endpoint was sustained virological 
      response at week 12 off therapy (SVR12). The safety profiles were also assessed. 
      RESULTS: A total of 110 CHC patients with 51% of males were enrolled. The median 
      age was 70 years. A majority (82%) of patients were infected with HCV genotype 2. 
      Forty-six (42%) and 64 (58%) patients had advanced hepatic fibrosis and 
      compensated cirrhosis, respectively. Forty-five (41%) non-cirrhotic patients were 
      treated for 8 weeks. The overall SVR12 rates were 100%, regardless of baseline 
      clinical characteristics. The common adverse events (AEs) were pruritus (12%), 
      anorexia (6%), and fatigue (5%). Nine (8%) serious AEs unrelated to GLE/PIB 
      occurred. Three (2%) patients had Grade 3 elevation of total bilirubin level. 
      None had premature treatment termination, hepatic decompensation, or death. 
      CONCLUSION: Interferon-free GLE/PIB regimen is highly effective and safe for 
      Asian chronic hepatitis C patients with advanced hepatic fibrosis or compensated 
      cirrhosis.
CI  - Copyright (c) 2019 Formosan Medical Association. Published by Elsevier B.V. All 
      rights reserved.
FAU - Hsu, Shih-Jer
AU  - Hsu SJ
AD  - Department of Internal Medicine, National Taiwan University Hospital, Yunlin 
      Branch, Douliou, Taiwan; Hepatology Medical Center, National Taiwan University 
      Hospital Yunlin Branch, Douliou, Taiwan.
FAU - Chiu, Min-Chin
AU  - Chiu MC
AD  - Department of Internal Medicine, National Taiwan University Hospital, Yunlin 
      Branch, Douliou, Taiwan; Hepatology Medical Center, National Taiwan University 
      Hospital Yunlin Branch, Douliou, Taiwan.
FAU - Fang, Yu-Jen
AU  - Fang YJ
AD  - Department of Internal Medicine, National Taiwan University Hospital, Yunlin 
      Branch, Douliou, Taiwan; Hepatology Medical Center, National Taiwan University 
      Hospital Yunlin Branch, Douliou, Taiwan.
FAU - Yang, Tsung-Hua
AU  - Yang TH
AD  - Department of Internal Medicine, National Taiwan University Hospital, Yunlin 
      Branch, Douliou, Taiwan; Hepatology Medical Center, National Taiwan University 
      Hospital Yunlin Branch, Douliou, Taiwan.
FAU - Yu, Jian-Jyun
AU  - Yu JJ
AD  - Department of Internal Medicine, National Taiwan University Hospital, Yunlin 
      Branch, Douliou, Taiwan; Hepatology Medical Center, National Taiwan University 
      Hospital Yunlin Branch, Douliou, Taiwan.
FAU - Chen, Chieh-Chang
AU  - Chen CC
AD  - Department of Internal Medicine, National Taiwan University Hospital, Yunlin 
      Branch, Douliou, Taiwan; Department of Internal Medicine, National Taiwan 
      University Hospital, Taipei, Taiwan.
FAU - Kuo, Chia-Chi
AU  - Kuo CC
AD  - Department of Internal Medicine, National Taiwan University Hospital, Yunlin 
      Branch, Douliou, Taiwan; Hepatology Medical Center, National Taiwan University 
      Hospital Yunlin Branch, Douliou, Taiwan.
FAU - Lee, Ji-Yuh
AU  - Lee JY
AD  - Department of Internal Medicine, National Taiwan University Hospital, Yunlin 
      Branch, Douliou, Taiwan; Hepatology Medical Center, National Taiwan University 
      Hospital Yunlin Branch, Douliou, Taiwan.
FAU - Chen, Chien-Hung
AU  - Chen CH
AD  - Department of Internal Medicine, National Taiwan University Hospital, Yunlin 
      Branch, Douliou, Taiwan; Hepatology Medical Center, National Taiwan University 
      Hospital Yunlin Branch, Douliou, Taiwan; Department of Internal Medicine, 
      National Taiwan University Hospital, Taipei, Taiwan.
FAU - Chen, Ding-Shinn
AU  - Chen DS
AD  - Department of Internal Medicine, National Taiwan University Hospital, Taipei, 
      Taiwan; Hepatitis Research Center, National Taiwan University Hospital, Taipei, 
      Taiwan; Genomics Research Center, Academia Sinica, Taipei, Taiwan.
FAU - Kao, Jia-Horng
AU  - Kao JH
AD  - Department of Internal Medicine, National Taiwan University Hospital, Taipei, 
      Taiwan; Hepatitis Research Center, National Taiwan University Hospital, Taipei, 
      Taiwan; Graduate Institute of Clinical Medicine, National Taiwan University 
      College of Medicine, Taipei, Taiwan. Electronic address: kaojh@ntu.edu.tw.
LA  - eng
PT  - Journal Article
DEP - 20190703
PL  - Singapore
TA  - J Formos Med Assoc
JT  - Journal of the Formosan Medical Association = Taiwan yi zhi
JID - 9214933
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  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Aminoisobutyric Acids
MH  - Antiviral Agents/adverse effects/*therapeutic use
MH  - Benzimidazoles/adverse effects/*therapeutic use
MH  - Cyclopropanes
MH  - Drug Therapy, Combination
MH  - Female
MH  - Hepacivirus/drug effects
MH  - Hepatitis C, Chronic/*drug therapy
MH  - Humans
MH  - Lactams, Macrocyclic
MH  - Leucine/analogs & derivatives
MH  - Liver Cirrhosis/pathology/*virology
MH  - Male
MH  - Middle Aged
MH  - Proline/analogs & derivatives
MH  - Pyrrolidines
MH  - Quinoxalines/adverse effects/*therapeutic use
MH  - Retrospective Studies
MH  - Sulfonamides/adverse effects/*therapeutic use
MH  - Sustained Virologic Response
MH  - Taiwan
OTO - NOTNLM
OT  - Chronic hepatitis C
OT  - Direct-acting antiviral
OT  - Glecaprevir
OT  - Pibrentasvir
OT  - Taiwan
EDAT- 2019/07/08 06:00
MHDA- 2020/01/16 06:00
CRDT- 2019/07/08 06:00
PHST- 2019/06/06 00:00 [received]
PHST- 2019/06/15 00:00 [revised]
PHST- 2019/06/20 00:00 [accepted]
PHST- 2019/07/08 06:00 [pubmed]
PHST- 2020/01/16 06:00 [medline]
PHST- 2019/07/08 06:00 [entrez]
AID - S0929-6646(19)30532-7 [pii]
AID - 10.1016/j.jfma.2019.06.014 [doi]
PST - ppublish
SO  - J Formos Med Assoc. 2019 Aug;118(8):1187-1192. doi: 10.1016/j.jfma.2019.06.014. 
      Epub 2019 Jul 3.