PMID- 33677787
OWN - NLM
STAT- MEDLINE
DCOM- 20211027
LR  - 20211027
IS  - 1936-0541 (Electronic)
IS  - 1936-0533 (Linking)
VI  - 15
IP  - 2
DP  - 2021 Apr
TI  - Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and 
      compensated liver disease: real-world data in Taiwan.
PG  - 338-349
LID - 10.1007/s12072-021-10158-x [doi]
AB  - BACKGROUND: Data regarding the real-world effectiveness and safety of 
      sofosbuvir/velpatasvir (SOF/VEL) for East Asian patients with chronic hepatitis C 
      virus (HCV) infection and compensated liver disease are limited. We evaluated the 
      performance of SOF/VEL for 12 weeks for HCV-infected patients with compensated 
      liver disease in a large real-world cohort in Taiwan. METHODS: Between July 2019 
      and March 2020, 1880 HCV-infected patients with compensated liver disease who 
      received SOF/VEL 400/100 mg once daily for 12 weeks were included at 15 academic 
      centers in Taiwan. The sustained virologic response at off-treatment week 12 
      (SVR(12)) was assessed for evaluable (EP) and per-protocol populations (PP). The 
      tolerance was also reported. RESULTS: The SVR(12) rates by EP and PP analyses 
      were 95.6% [1798 of 1880 patients; 95% confidence interval (CI) 94.6-96.5%] and 
      99.3% (1798 of 1811 patients; 95% CI 98.8-99.6%), respectively. Among 82 patients 
      who failed to achieve SVR(12), 13 (15.9%) were attributed to virologic failures. 
      The SVR(12) rates were comparable regardless of baseline characteristics. A total 
      of 1859 (98.9%) patients completed 12-week SOF/VEL treatment. Four (0.2%) 
      patients discontinued treatment due to adverse events (AEs). All patients with 
      serious AEs or deaths were judged not related to SOF/VEL. The AEs occurring 
      in >/= 10% included headache (16.8%), fatigue (16.2%), nausea (11.8%), and insomnia 
      (11.1%). Nine (0.5%) and 2 (0.1%) patients had grade 3 total bilirubin and 
      alanine aminotransferase elevations. CONCLUSIONS: SOF/VEL for 12 weeks is 
      efficacious and well-tolerated by chronic HCV-infected patients with compensated 
      liver disease in Taiwan.
FAU - Liu, Chen-Hua
AU  - Liu CH
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, Yunlin, Taiwan.
FAU - Chen, Po-Yueh
AU  - Chen PY
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi, Taiwan.
FAU - Chen, Jyh-Jou
AU  - Chen JJ
AD  - Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Liouying, 
      Tainan, Taiwan.
FAU - Lo, Ching-Chu
AU  - Lo CC
AD  - Department of Internal Medicine, St. Martin De Porres Hospital, Daya, Chiayi, 
      Taiwan.
FAU - Su, Wei-Wen
AU  - Su WW
AD  - Division of Gastroenterology, Department of Internal Medicine, Changhua Christian 
      Hospital, Changhua, 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 - 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.
FAU - Huang, Chia-Sheng
AU  - Huang CS
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Yang Ming Hospital, Chiayi, Taiwan.
FAU - Huang, Ke-Jhang
AU  - Huang KJ
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      China Medical University Beigang Hospital, Yunlin, 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  - Institute of Biomedical Sciences, National Chung Hsing University, Taichung, 
      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 - Tsai, Ming-Chang
AU  - Tsai MC
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Chung Shan Medical University Hospital, Taichung, Taiwan.
FAU - Kao, Wei-Yu
AU  - Kao WY
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.
AD  - Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical 
      University, Taipei, Taiwan.
FAU - Chang, Chi-Yang
AU  - Chang CY
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Fu 
      Jen Catholic University Hospital, Taipei, Taiwan.
FAU - Shih, Yu-Lueng
AU  - Shih YL
AD  - Division of Gastroenterology, Department of Internal Medicine, Tri-Service 
      General Hospital, National Defense Medical Center, Taipei, Taiwan.
FAU - Fang, Yu-Jen
AU  - Fang YJ
AD  - Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin 
      Branch, Yunlin, Taiwan.
FAU - Chen, Chi-Yi
AU  - Chen CY
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi, Taiwan.
FAU - Lee, Pei-Lun
AU  - Lee PL
AD  - Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Liouying, 
      Tainan, Taiwan.
FAU - Huang, Jow-Jyh
AU  - Huang JJ
AD  - Department of Internal Medicine, St. Martin De Porres Hospital, Daya, Chiayi, 
      Taiwan.
FAU - Su, Pei-Yuan
AU  - Su PY
AD  - Division of Gastroenterology, Department of Internal Medicine, Changhua Christian 
      Hospital, Changhua, Taiwan.
FAU - Tseng, Chi-Wei
AU  - Tseng CW
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, Chien-Ching
AU  - Hung CC
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 - Chang, Chung-Hsin
AU  - Chang CH
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Taichung Veterans General Hospital, Taichung, Taiwan.
FAU - Huang, Yi-Jie
AU  - Huang YJ
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Taichung Veterans General Hospital, Taichung, Taiwan.
FAU - Lai, Hsueh-Chou
AU  - Lai HC
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 - 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.
AD  - Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical 
      University, Taipei, Taiwan.
FAU - Lee, Fu-Jen
AU  - Lee FJ
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Fu 
      Jen Catholic University Hospital, Taipei, 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 - Kao, Jia-Horng
AU  - Kao JH
AUID- ORCID: 0000-0002-2442-7952
AD  - Department of Internal Medicine, National Taiwan University Hospital, Taipei, 
      Taiwan. kaojh@ntu.edu.tw.
AD  - Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. 
      kaojh@ntu.edu.tw.
AD  - Graduate Institute of Clinical Medicine, National Taiwan University College of 
      Medicine, 7 Chung-Shan South Road, Taipei, 10002, Taiwan. kaojh@ntu.edu.tw.
LA  - eng
GR  - 106-2314-B-002-138-MY3/Ministry of Science and Technology, Taiwan/
GR  - 107-2314-B-002-038-MY2/Ministry of Science and Technology, Taiwan/
PT  - Journal Article
DEP - 20210306
PL  - United States
TA  - Hepatol Int
JT  - Hepatology international
JID - 101304009
RN  - 0 (Antiviral Agents)
RN  - 0 (Carbamates)
RN  - 0 (Heterocyclic Compounds, 4 or More Rings)
RN  - KCU0C7RS7Z (velpatasvir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Antiviral Agents/therapeutic use
MH  - Carbamates/therapeutic use
MH  - Genotype
MH  - Hepacivirus/genetics
MH  - *Hepatitis C, Chronic/complications/drug therapy
MH  - Heterocyclic Compounds, 4 or More Rings/therapeutic use
MH  - Humans
MH  - Sofosbuvir/therapeutic use
MH  - Sustained Virologic Response
MH  - Taiwan/epidemiology
OTO - NOTNLM
OT  - Adverse event
OT  - Direct acting antiviral
OT  - East Asian
OT  - Effectiveness
OT  - Hepatitis C virus
OT  - Pangenotypic
OT  - Safety
OT  - Sofosbuvir
OT  - Sustained virologic response
OT  - Velpatasvir
EDAT- 2021/03/08 06:00
MHDA- 2021/10/28 06:00
CRDT- 2021/03/07 20:43
PHST- 2020/12/30 00:00 [received]
PHST- 2021/02/11 00:00 [accepted]
PHST- 2021/03/08 06:00 [pubmed]
PHST- 2021/10/28 06:00 [medline]
PHST- 2021/03/07 20:43 [entrez]
AID - 10.1007/s12072-021-10158-x [pii]
AID - 10.1007/s12072-021-10158-x [doi]
PST - ppublish
SO  - Hepatol Int. 2021 Apr;15(2):338-349. doi: 10.1007/s12072-021-10158-x. Epub 2021 
      Mar 6.