PMID- 34255961
OWN - NLM
STAT- MEDLINE
DCOM- 20211103
LR  - 20211103
IS  - 2287-285X (Electronic)
IS  - 2287-2728 (Print)
IS  - 2287-2728 (Linking)
VI  - 27
IP  - 4
DP  - 2021 Oct
TI  - Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis 
      C virus-related cirrhosis.
PG  - 575-588
LID - 10.3350/cmh.2021.0155 [doi]
AB  - BACKGROUND/AIMS: Real-world studies assessing the effectiveness and safety of 
      sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C 
      hepatitis C virus (HCV)-related cirrhosis are limited. METHODS: We included 107 
      patients with Child-Pugh B/C HCV-related cirrhosis receiving SOF/VEL plus RBV for 
      12 weeks in Taiwan. The sustained virologic response rates at off-treatment week 
      12 (SVR12) for the evaluable population (EP), modified EP, and per-protocol 
      population (PP) were assessed. Thesafety profiles were reported. RESULTS: The 
      SVR12 rates in the EP, modified EP and PP were 89.7% (95% confidence interval 
      [CI], 82.5-94.2%), 94.1% (95% CI, 87.8-97.3%), and 100% (95% CI, 96.2-100%). 
      Number of patients who failed to achieve SVR12 were attributed to virologic 
      failures. The SVR12 rates were comparable regardless of patient characteristics. 
      One patient discontinued treatment because of adverse events (AEs). Twenty-four 
      patients had serious AEs and six died, but none were related to SOF/VEL or RBV. 
      Among the 96 patients achieving SVR12, 84.4% and 64.6% had improved Child-Pugh 
      and model for endstage liver disease (MELD) scores. Multivariate analysis 
      revealed that a baseline MELD score >/=15 was associated with an improved MELD 
      score of >/=3 (odds ratio, 4.13; 95% CI, 1.16-14.71; P=0.02). Patients with chronic 
      kidney disease (CKD) stage 1 had more significant estimated glomerular filtration 
      rate declines than patients with CKD stage 2 (-0.42 mL/min/1.73 m2/month; P=0.01) 
      or stage 3 (-0.56 mL/min/1.73 m2/month; P<0.001). CONCLUSION: SOF/VEL plus RBV 
      for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related 
      cirrhosis.
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, Chi-Yi
AU  - Chen CY
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi, Taiwan.
FAU - Su, Wei-Wen
AU  - Su WW
AD  - Division of Gastroenterology, Department of Internal Medicine, Changhua Christian 
      Hospital, Changhua, 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 - Lo, Ching-Chu
AU  - Lo CC
AD  - Department of Internal Medicine, St. Martin De Porres 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 - Chen, Jyh-Jou
AU  - Chen JJ
AD  - Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Liouying, 
      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 - Chang, Chi-Yang
AU  - Chang CY
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Fu 
      Jen Catholic University Hospital, Taipei, 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 - 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 - Huang, Chia-Sheng
AU  - Huang CS
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Yang Ming Hospital, Chiayi, 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  - School of Medicine, Taipei Medical University College of Medicine, Taipei, 
      Taiwan.
AD  - Graduate Institute of Clinical Medicine, Taipei Medical University College of 
      Medicine, Taipei, 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 - Tsai, Ming-Chang
AU  - Tsai MC
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Chung Shan Medical University Hospital, Taichung, Taiwan.
FAU - Wu, Jo-Hsuan
AU  - Wu JH
AD  - Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of 
      Ophthalmology, University of California, San Diego, CA, USA.
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 - Su, Pei-Yuan
AU  - Su PY
AD  - Division of Gastroenterology, Department of Internal Medicine, Changhua Christian 
      Hospital, Changhua, Taiwan.
FAU - Hwang, Jow-Jyh
AU  - Hwang JJ
AD  - Department of Internal Medicine, St. Martin De Porres Hospital, Chiayi, Taiwan.
FAU - Fang, Yu-Jen
AU  - Fang YJ
AD  - Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin 
      Branch, Yunlin, Taiwan.
FAU - Lee, Pei-Lun
AU  - Lee PL
AD  - Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Liouying, 
      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 - Lee, Fu-Jen
AU  - Lee FJ
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Fu 
      Jen Catholic University Hospital, Taipei, 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 - 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 - Chang, Chun-Chao
AU  - Chang CC
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, 
      Taipei Medical University Hospital, Taipei, Taiwan.
AD  - School of Medicine, Taipei Medical University College of Medicine, Taipei, 
      Taiwan.
AD  - Graduate Institute of Clinical Medicine, Taipei Medical 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 - Kao, Jia-Horng
AU  - Kao JH
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.
AD  - Department of Medical Research, National Taiwan University Hospital, Taipei, 
      Taiwan.
LA  - eng
GR  - 107-2314-B-002-038-MY2/Ministry of Science and Technology, Taiwan/
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210713
PL  - Korea (South)
TA  - Clin Mol Hepatol
JT  - Clinical and molecular hepatology
JID - 101586730
RN  - 0 (Antiviral Agents)
RN  - 0 (Carbamates)
RN  - 0 (Heterocyclic Compounds, 4 or More Rings)
RN  - 49717AWG6K (Ribavirin)
RN  - KCU0C7RS7Z (velpatasvir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Antiviral Agents/therapeutic use
MH  - Carbamates
MH  - Genotype
MH  - Hepacivirus/genetics
MH  - *Hepatitis C/complications/diagnosis/drug therapy
MH  - *Hepatitis C, Chronic/complications/drug therapy
MH  - Heterocyclic Compounds, 4 or More Rings
MH  - Humans
MH  - Liver Cirrhosis/complications/diagnosis/drug therapy
MH  - Ribavirin/therapeutic use
MH  - Sofosbuvir/therapeutic use
MH  - Treatment Outcome
PMC - PMC8524072
OTO - NOTNLM
OT  - Antiviral agents
OT  - Hepatitis, Chronic
OT  - Liver cirrhosis
OT  - Ribavirin
OT  - Sofosbuvir
COIS- Conflicts of Interest Chen-Hua Liu: advisory board for Abbvie, Gilead Sciences, 
      Merck Sharp & Dohme; speaker's bureau for Abbott, Abbvie, Gilead Sciences, Merck 
      Sharp & Dohme; research grant from Abbvie, Gilead Science, Merck Sharp & Dohme. 
      Sheng-Shun Yang: advisory board for Abbvie, Roche, Ipsen; speaker's bureau for 
      Abbvie, Bristol-Myers Squibb, Gilead Sciences, Ipsen, Merck Sharp & Dohme. Jia- 
      Horng Kao: advisory board for Abbott, Abbvie, Bristol-Myers Squibb, Gilead 
      Sciences, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche; speaker's bureau 
      for Abbott, Abbvie, Bayer, Bristol-Myers Squibb, Gilead Sciences, 
      GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche. All the other authors 
      declare no competing interests.
EDAT- 2021/07/14 06:00
MHDA- 2021/11/04 06:00
PMCR- 2021/10/01
CRDT- 2021/07/13 19:54
PHST- 2021/06/27 00:00 [received]
PHST- 2021/07/06 00:00 [accepted]
PHST- 2021/07/14 06:00 [pubmed]
PHST- 2021/11/04 06:00 [medline]
PHST- 2021/07/13 19:54 [entrez]
PHST- 2021/10/01 00:00 [pmc-release]
AID - cmh.2021.0155 [pii]
AID - cmh-2021-0155 [pii]
AID - 10.3350/cmh.2021.0155 [doi]
PST - ppublish
SO  - Clin Mol Hepatol. 2021 Oct;27(4):575-588. doi: 10.3350/cmh.2021.0155. Epub 2021 
      Jul 13.