PMID- 33408122
OWN - NLM
STAT- MEDLINE
DCOM- 20220110
LR  - 20220110
IS  - 1468-3288 (Electronic)
IS  - 0017-5749 (Linking)
VI  - 71
IP  - 1
DP  - 2022 Jan
TI  - Sofosbuvir/velpatasvir with or without low-dose ribavirin for patients with 
      chronic hepatitis C virus infection and severe renal impairment.
PG  - 176-184
LID - 10.1136/gutjnl-2020-323569 [doi]
AB  - OBJECTIVE: Data regarding the real-world effectiveness and safety of 
      sofosbuvir/velpatasvir (SOF/VEL) with or without low-dose ribavirin (RBV) in 
      patients with chronic hepatitis C virus (HCV) infection and severe renal 
      impairment (RI) are limited. We evaluated the performance of SOF/VEL with or 
      without low-dose RBV in HCV-infected patients with chronic kidney disease stage 4 
      or 5. DESIGN: 191 patients with compensated (n=181) and decompensated (n=10) 
      liver diseases receiving SOF/VEL (400/100 mg/day) alone and SOF/VEL with low-dose 
      RBV (200 mg/day) for 12 weeks were retrospectively recruited at 15 academic 
      centres in Taiwan. The effectiveness was determined by sustained virological 
      response at off-treatment week 12 (SVR(12)) in evaluable (EP) and per-protocol 
      populations (PP). The safety profiles were assessed. RESULTS: The SVR(12) rates 
      by EP and PP analyses were 94.8% (95% CI 90.6% to 97.1%) and 100% (95% CI 97.9% 
      to 100%). In patients with compensated liver disease, the SVR(12) rates were 
      95.0% and 100% by EP and PP analyses. In patients with decompensated liver 
      disease, the SVR(12) rates were 90.0% and 100% by EP and PP analyses. Ten 
      patients who failed to achieve SVR(12) were attributed to non-virological 
      failures. Among the 20 serious adverse events (AEs), none were judged related to 
      SOF/VEL or RBV. The AEs occurring in >/=10% included fatigue (14.7%), headache 
      (14.1%), nausea (12.6%), insomnia (12.0%) and pruritus (10.5%). None had >/=grade 3 
      total bilirubin or alanine aminotransferase elevations. CONCLUSION: SOF/VEL with 
      or without low-dose RBV is effective and well-tolerated in HCV-infected patients 
      with severe RI.
CI  - (c) Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and 
      permissions. Published by BMJ.
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 - Tseng, Kuo-Chih
AU  - Tseng KC
AUID- ORCID: 0000-0002-4811-3018
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 - Lo, Ching-Chu
AU  - Lo CC
AD  - Department of Internal Medicine, St. Martin De Porres Hospital, Daya, Chiayi, 
      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 - Chen, Jyh-Jou
AU  - Chen JJ
AD  - Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Liouying, 
      Taiwan.
FAU - Peng, Cheng-Yuan
AU  - Peng CY
AUID- ORCID: 0000-0001-9030-6086
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 - 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 - 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 - Chang, Chi-Yang
AU  - Chang CY
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Fu 
      Jen Catholic University Hospital, Taipei, 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 - Fang, Yo-Jen
AU  - Fang YJ
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 - Su, Pei-Yuan
AU  - Su PY
AD  - Division of Gastroenterology, Department of Internal Medicine, Changhua Christian 
      Hospital, Changhua, Taiwan.
FAU - Tseng, Chih-Wei
AU  - Tseng CW
AUID- ORCID: 0000-0002-6951-4646
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 - Huang, Jow-Jyh
AU  - Huang JJ
AD  - Department of Internal Medicine, St. Martin De Porres Hospital, Daya, Chiayi, 
      Taiwan.
FAU - Lee, Pei-Lun
AU  - Lee PL
AD  - Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Liouying, 
      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, 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 - Lee, Fu-Jen
AU  - Lee FJ
AD  - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Fu 
      Jen Catholic University Hospital, Taipei, Taiwan.
FAU - Chang, Chun-Chao
AU  - Chang CC
AUID- ORCID: 0000-0002-3396-1559
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 - 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.
AD  - Graduate Institute of Clinical Medicine, National Taiwan University College of 
      Medicine, Taipei, Taiwan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20210106
PL  - England
TA  - Gut
JT  - Gut
JID - 2985108R
RN  - 0 (Antiviral Agents)
RN  - 0 (Carbamates)
RN  - 0 (Drug Combinations)
RN  - 0 (Heterocyclic Compounds, 4 or More Rings)
RN  - 0 (sofosbuvir-velpatasvir drug combination)
RN  - 49717AWG6K (Ribavirin)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antiviral Agents/*therapeutic use
MH  - Carbamates/*therapeutic use
MH  - Drug Combinations
MH  - Drug Therapy, Combination
MH  - Female
MH  - Hepatitis C, Chronic/complications/*drug therapy
MH  - Heterocyclic Compounds, 4 or More Rings/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Renal Insufficiency, Chronic/classification/*complications
MH  - Retrospective Studies
MH  - Ribavirin/*therapeutic use
MH  - Sofosbuvir/*therapeutic use
MH  - Sustained Virologic Response
MH  - Young Adult
OTO - NOTNLM
OT  - chronic kidney disease
OT  - direct acting antiviral
OT  - hepatitis C virus
OT  - renal impairment
OT  - sofosbuvir
OT  - velpatasvir
COIS- Competing interests: C-HL: 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. S-SY: 
      advisory board for Abbvie, Roche, Ipsen; speaker's bureau for Abbvie, 
      Bristol-Myers Squibb, Gilead Sciences, Ipsen, Merck Sharp & Dohme. P-YC: advisory 
      board for Abbvie, Novartis, Roche; J-HK: 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 other authors declare no competing interests.
EDAT- 2021/01/08 06:00
MHDA- 2022/01/11 06:00
CRDT- 2021/01/07 05:59
PHST- 2020/11/06 00:00 [received]
PHST- 2020/12/21 00:00 [revised]
PHST- 2020/12/23 00:00 [accepted]
PHST- 2021/01/08 06:00 [pubmed]
PHST- 2022/01/11 06:00 [medline]
PHST- 2021/01/07 05:59 [entrez]
AID - gutjnl-2020-323569 [pii]
AID - 10.1136/gutjnl-2020-323569 [doi]
PST - ppublish
SO  - Gut. 2022 Jan;71(1):176-184. doi: 10.1136/gutjnl-2020-323569. Epub 2021 Jan 6.