PMID- 36973633
OWN - NLM
STAT- MEDLINE
DCOM- 20230529
LR  - 20230530
IS  - 1936-0541 (Electronic)
IS  - 1936-0533 (Print)
IS  - 1936-0533 (Linking)
VI  - 17
IP  - 3
DP  - 2023 Jun
TI  - Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV 
      treatment-naive patients with compensated cirrhosis: real-world experience from 
      Taiwan nationwide HCV registry.
PG  - 550-561
LID - 10.1007/s12072-023-10506-z [doi]
AB  - BACKGROUND: Large-scale real-world data of the 8-week glecaprevir/pibrentasvir 
      (GLE/PIB) therapy for treatment-naive 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-naive 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/microl, and 
      FibroScan > 20 kPa and platelet < 150,000/microl, 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-naive compensated cirrhosis patients. SVR12 rates were similarly high 
      as in the clinical trials, including those with characteristics of advanced liver 
      disease.
CI  - (c) 2023. Asian Pacific Association for the Study of the Liver.
FAU - Chang, Te-Sheng
AU  - Chang TS
AD  - Division of Hepatogastroenterology, Department of Internal Medicine, Chang Gung 
      Memorial Hospital, Chiayi, Taiwan.
AD  - College of Medicine, Chang Gung University, Taoyuan, Taiwan.
FAU - Huang, Chung-Feng
AU  - Huang CF
AD  - Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, 
      Kaohsiung Medical University Hospital, College of Medicine, Kaohsiung Medical 
      University, Kaohsiung, Taiwan.
AD  - Ph.D. Program in Translational Medicine, College of Medicine, Kaohsiung Medical 
      University, Academia Sinica, Kaohsiung, Taiwan.
FAU - Kuo, Hsing-Tao
AU  - Kuo HT
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chi 
      Mei Medical Center, Yongkang District, Tainan, Taiwan.
FAU - Lo, Ching-Chu
AU  - Lo CC
AD  - Division of Gastroenterology, Department of Internal Medicine, St. Martin De 
      Porres Hospital, Chiayi, Taiwan.
FAU - Huang, Chien-Wei
AU  - Huang CW
AD  - Division of Gastroenterology, Kaohsiung Armed Forces General Hospital, Kaohsiung, 
      Taiwan.
FAU - Chong, Lee-Won
AU  - Chong LW
AD  - Division of Hepatology and Gastroenterology, Department of Internal Medicine, 
      Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.
AD  - School of Medicine, Fu-Jen Catholic University, New Taipei City, Taiwan.
FAU - Cheng, Pin-Nan
AU  - Cheng PN
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      National Cheng Kung University Hospital, College of Medicine, National Cheng Kung 
      University, Tainan, Taiwan.
FAU - Yeh, Ming-Lun
AU  - Yeh ML
AD  - Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, 
      Kaohsiung Medical University Hospital, College of Medicine, Kaohsiung Medical 
      University, Kaohsiung, Taiwan.
AD  - Center for Liquid Biopsy and Cohort Research, Kaohsiung Medical University, 
      Kaohsiung, Taiwan.
FAU - Peng, Cheng-Yuan
AU  - Peng CY
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 - Cheng, Chien-Yu
AU  - Cheng CY
AD  - Division of Infectious Diseases, Department of Internal Medicine, Taoyuan General 
      Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.
FAU - Huang, Jee-Fu
AU  - Huang JF
AD  - Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, 
      Kaohsiung Medical University Hospital, College of Medicine, Kaohsiung Medical 
      University, Kaohsiung, Taiwan.
AD  - Hepatitis Research Center, College of Medicine, Kaohsiung Medical University, 
      Kaohsiung, Taiwan.
FAU - Bair, Ming-Jong
AU  - Bair MJ
AD  - Division of Gastroenterology, Department of Internal Medicine, Taitung Mackay 
      Memorial Hospital, Taitung, Taiwan.
AD  - Mackay Medical College, New Taipei City, Taiwan.
FAU - Lin, Chih-Lang
AU  - Lin CL
AD  - Liver Research Unit, Department of Hepato-Gastroenterology and Community Medicine 
      Research Center, Chang Gung Memorial Hospital at Keelung, College of Medicine, 
      Chang Gung University, Keelung, Taiwan.
FAU - Yang, Chi-Chieh
AU  - Yang CC
AD  - Department of Gastroenterology, Division of Internal Medicine, Show Chwan 
      Memorial Hospital, Changhua, Taiwan.
FAU - Wang, Szu-Jen
AU  - Wang SJ
AD  - Division of Gastroenterology, Department of Internal Medicine, Yuan's General 
      Hospital, Kaohsiung, Taiwan.
FAU - Hsieh, Tsai-Yuan
AU  - Hsieh TY
AD  - Division of Gastroenterology, Department of Internal Medicine, Tri‑Service 
      General Hospital, National Defense Medical Center, Taipei, Taiwan.
FAU - Lee, Tzong-Hsi
AU  - Lee TH
AD  - Division of Gastroenterology and Hepatology, Far Eastern Memorial Hospital, New 
      Taipei City, Taiwan.
FAU - Lee, Pei-Lun
AU  - Lee PL
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chi 
      Mei Medical Center, Liouying, Tainan, Taiwan.
FAU - Wu, Wen-Chih
AU  - Wu WC
AD  - Wen-Chih Wu Clinic, Fengshan, Kaohsiung, Taiwan.
FAU - Lin, Chih-Lin
AU  - Lin CL
AD  - Department of Gastroenterology, Renai Branch, Taipei City Hospital, Taipei, 
      Taiwan.
FAU - Su, Wei-Wen
AU  - Su WW
AD  - Department of Gastroenterology and Hepatology, Changhua Christian Hospital, 
      Changhua, 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  - Institute of Biomedical Sciences, National Chung Hsing University, Taichung, 
      Taiwan.
AD  - Department of Post-Baccalaureate Medicine, College of Medicine, National Chung 
      Hsing University, Taichung, Taiwan.
FAU - Wang, Chia-Chi
AU  - Wang CC
AD  - Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of 
      Medicine, Tzu Chi University, Taipei, Taiwan.
FAU - Hu, Jui-Ting
AU  - Hu JT
AD  - Liver Center, Cathay General Hospital, Taipei, Taiwan.
FAU - Mo, Lein-Ray
AU  - Mo LR
AD  - Division of Gastroenterology, Tainan Municipal Hospital (Managed By Show Chwan 
      Medical Care Corporation), Tainan, Taiwan.
FAU - Chen, Chun-Ting
AU  - Chen CT
AD  - Division of Gastroenterology, Department of Internal Medicine, Tri‑Service 
      General Hospital, National Defense Medical Center, Taipei, Taiwan.
AD  - Division of Gastroenterology, Department of Internal Medicine, Tri‑Service 
      General Hospital Penghu Branch, National Defense Medical Center, Taipei, Taiwan.
FAU - Huang, Yi-Hsiang
AU  - Huang YH
AD  - Division of Gastroenterology and Hepatology, Department of Medicine, Taipei 
      Veterans General Hospital, Taipei, Taiwan.
AD  - Institute of Clinical Medicine, School of Medicine, National Yang-Ming Chiao Tung 
      University, Taipei, Taiwan.
FAU - Chang, Chun-Chao
AU  - Chang CC
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Taipei Medical University Hospital, Taipei, Taiwan.
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      School of Medicine, College of Medicine, Taipei Medical University, Taipei, 
      Taiwan.
FAU - Huang, Chia-Sheng
AU  - Huang CS
AD  - Yang Ming Hospital, Chiayi, Taiwan.
FAU - Chen, Guei-Ying
AU  - Chen GY
AD  - Penghu Hospital, Ministry of Health and Welfare, Penghu, Taiwan.
FAU - Kao, Chien-Neng
AU  - Kao CN
AD  - National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan.
FAU - Tai, Chi-Ming
AU  - Tai CM
AD  - Department of Internal Medicine, E-Da Hospital, Kaohsiung, Taiwan.
AD  - School of Medicine, College of Medicine, I-Shou University, Kaohsiung, Taiwan.
FAU - Liu, Chun-Jen
AU  - Liu CJ
AD  - Hepatitis Research Center and Department of Internal Medicine, National Taiwan 
      University Hospital, Taipei, Taiwan.
FAU - Lee, Mei-Hsuan
AU  - Lee MH
AD  - Institute of Clinical Medicine, National Yang-Ming Chiao Tung University, Taipei, 
      Taiwan.
FAU - Tsai, Pei-Chien
AU  - Tsai PC
AD  - Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, 
      Kaohsiung Medical University Hospital, College of Medicine, Kaohsiung Medical 
      University, Kaohsiung, Taiwan.
FAU - Dai, Chia-Yen
AU  - Dai CY
AD  - Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, 
      Kaohsiung Medical University Hospital, College of Medicine, Kaohsiung Medical 
      University, Kaohsiung, Taiwan.
FAU - Kao, Jia-Horng
AU  - Kao JH
AD  - Hepatitis Research Center and Department of Internal Medicine, National Taiwan 
      University Hospital, Taipei, Taiwan.
FAU - Lin, Han-Chieh
AU  - Lin HC
AD  - Division of Gastroenterology and Hepatology, Department of Medicine, Taipei 
      Veterans General Hospital, Taipei, Taiwan.
AD  - Institute of Clinical Medicine, School of Medicine, National Yang-Ming Chiao Tung 
      University, Taipei, Taiwan.
FAU - Chuang, Wang-Long
AU  - Chuang WL
AD  - Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, 
      Kaohsiung Medical University Hospital, College of Medicine, Kaohsiung Medical 
      University, Kaohsiung, Taiwan.
FAU - Chen, Chi-Yi
AU  - Chen CY
AD  - Division of Gastroenterology and Hepatology, Department of Medicine, Ditmanson 
      Medical Foundation Chiayi Christian Hospital, Chiayi, Taiwan.
FAU - Tseng, Kuo-Chih
AU  - Tseng KC
AD  - Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical 
      Foundation, Chiayi, Taiwan.
AD  - School of Medicine, Tzuchi University, Hualien, Taiwan.
FAU - Hung, Chao-Hung
AU  - Hung CH
AUID- ORCID: 0000-0003-1646-9519
AD  - Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung 
      Chang Gung Memorial Hospital, Kaohsiung, Taiwan. chh4366@yahoo.com.tw.
FAU - Yu, Ming-Lung
AU  - Yu ML
AUID- ORCID: 0000-0001-8145-1900
AD  - Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, 
      Kaohsiung Medical University Hospital, College of Medicine, Kaohsiung Medical 
      University, Kaohsiung, Taiwan. fish6069@gmail.com.
AD  - Center for Liquid Biopsy and Cohort Research, Kaohsiung Medical University, 
      Kaohsiung, Taiwan. fish6069@gmail.com.
AD  - Hepatitis Research Center, College of Medicine, Kaohsiung Medical University, 
      Kaohsiung, Taiwan. fish6069@gmail.com.
AD  - Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung 
      Chang Gung Memorial Hospital, Kaohsiung, Taiwan. fish6069@gmail.com.
AD  - School of Medicine, College of Medicine, Center of Excellence for Metabolic 
      Associated Fatty Liver Disease, National Sun Yat-Sen University, Kaohsiung, 
      Taiwan. fish6069@gmail.com.
LA  - eng
GR  - 100CM-KMU-09/Kaohsiung Medical University/
GR  - KMU-TC109B05/Kaohsiung Medical University/
GR  - MOST 108-2314-B-037 -066 -MY3/Kaohsiung Medical University/
GR  - KMU-KI110002/Kaohsiung Medical University/
GR  - KMUH109-9R06/Kaohsiung Medical University Chung-Ho Memorial Hospital/
GR  - KMUH-DK(C)110011/Kaohsiung Medical University Chung-Ho Memorial Hospital/
GR  - KMUH-DK(C)110004/Kaohsiung Medical University Chung-Ho Memorial Hospital/
GR  - KMUH109-9R05/Kaohsiung Medical University Chung-Ho Memorial Hospital/
PT  - Journal Article
DEP - 20230327
PL  - United States
TA  - Hepatol Int
JT  - Hepatology international
JID - 101304009
RN  - K6BUU8J72P (glecaprevir)
RN  - 2WU922TK3L (pibrentasvir)
RN  - 0 (Quinoxalines)
RN  - 0 (Antiviral Agents)
RN  - 9DLQ4CIU6V (Proline)
SB  - IM
MH  - Humans
MH  - *Hepatitis C, Chronic/complications/drug therapy/epidemiology
MH  - Taiwan/epidemiology
MH  - Hepacivirus/genetics
MH  - Liver Cirrhosis/epidemiology
MH  - Sustained Virologic Response
MH  - Quinoxalines/adverse effects
MH  - Antiviral Agents/adverse effects
MH  - Registries
MH  - Proline
MH  - Genotype
PMC - PMC10042416
OTO - NOTNLM
OT  - Compensated cirrhosis
OT  - GLE/PIB
OT  - HCV
OT  - Sustained virologic response
COIS- Ming-Lung Yu: Research support from Abbvie, Abbott, BMS, Gilead, Merck and Roche. 
      Consultant for Abbvie, Abbott, Ascletis, BMS, Gilead, J&J, Merck, Novartis, 
      Pharmaessential and Roche. Speaker for Abbvie, Abbott, Ascletis, BMS, Gilead, 
      Merck, Pharmaessential and Roche. Sheng-Shun Yang: Speaker for AbbVie, 
      Bristol-Myers, Squibb, Gilead Sciences, Ipsen, and Merck Sharp & Dohme. Advisory 
      board member for AbbVie, Gilead Sciences, Hoffmann-LaRoche, and Ipsen. Te-Sheng 
      Chang, Chung-Feng Huang, Hsing-Tao Kuo, Ching-Chu Lo, Chien-Wei Huang, Lee-Won 
      Chong, Pin-Nan Cheng, Ming-Lun Yeh, Cheng-Yuan Peng, Chien-Yu Cheng, Jee-Fu 
      Huang, Ming-Jong Bair, Chih-Lang Lin, Chi-Chieh Yang, Szu-Jen Wang, Tsai-Yuan 
      Hsieh, Tzong-Hsi Lee, Pei-Lun Lee, Wen-Chih Wu, Chih-Lin Lin, Wei-Wen Su, 
      Chia-Chi Wang, Jui-Ting Hu, Lein-Ray Mo, Chun-Ting Chen, Yi-Hsiang Huang, 
      Chun-Chao Chang, Chia-Sheng Huang, Guei-Ying Chen, Chien-Neng Kao, Chi-Ming Tai, 
      Chun-Jen Liu, Mei-Hsuan Lee, Pei-Chien Tsai, Chia-Yen Dai, Jia-Horng Kao, 
      Han-Chieh Lin, Wang-Long Chuang, Chi-Yi Chen, Kuo-Chih Tseng, and Chao-Hung 
      Hung declare no conflict of interest.
EDAT- 2023/03/28 06:00
MHDA- 2023/05/29 06:42
PMCR- 2023/03/27
CRDT- 2023/03/27 23:32
PHST- 2022/10/28 00:00 [received]
PHST- 2023/02/22 00:00 [accepted]
PHST- 2023/05/29 06:42 [medline]
PHST- 2023/03/28 06:00 [pubmed]
PHST- 2023/03/27 23:32 [entrez]
PHST- 2023/03/27 00:00 [pmc-release]
AID - 10.1007/s12072-023-10506-z [pii]
AID - 10506 [pii]
AID - 10.1007/s12072-023-10506-z [doi]
PST - ppublish
SO  - Hepatol Int. 2023 Jun;17(3):550-561. doi: 10.1007/s12072-023-10506-z. Epub 2023 
      Mar 27.