Clinical outcomes of sofosbuvir/velpatasvir in hepatitis C virus-infected patients with end-stage renal disease on maintenance hemodialysis

Objective To evaluate the safety and efficacy of 12-week sofosbuvir/velpatasvir (SOF/VEL) in chronic hepatitis C (CHC) patients with end-stage renal disease (ESRD) on maintenance hemodialysis (MHD) in a real-world setting. Methods From October 10, 2020 to January 28, 2021, 18 CHC patients received f...

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Main Authors: Li-xia Yu, Jian-ming Ye, Xiao-ya Yin, Qi-feng Liu, Qiang Sun
Format: Article
Language:zho
Published: Editorial Department of Journal of Clinical Nephrology 2023-10-01
Series:Linchuang shenzangbing zazhi
Subjects:
Online Access:http://www.lcszb.com/cn/article/doi/10.3969/j.issn.1671-2390.2023.10.008
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author Li-xia Yu
Jian-ming Ye
Xiao-ya Yin
Qi-feng Liu
Qiang Sun
author_facet Li-xia Yu
Jian-ming Ye
Xiao-ya Yin
Qi-feng Liu
Qiang Sun
author_sort Li-xia Yu
collection DOAJ
description Objective To evaluate the safety and efficacy of 12-week sofosbuvir/velpatasvir (SOF/VEL) in chronic hepatitis C (CHC) patients with end-stage renal disease (ESRD) on maintenance hemodialysis (MHD) in a real-world setting. Methods From October 10, 2020 to January 28, 2021, 18 CHC patients received full-dose sofosbuvir (400 mg) plus velpatasvir (100 mg) once daily for 12 weeks. HCV RNA quantification, hepaticorenal function and electrolytes were assessed at baseline, end of treatment (EOT) and Week 12/48 after discontinuing therapy. Primary outcome was sustained virological response at Week 12 post-treatment (SVR12, HCV RNA negative). Safety profile was evaluated by monitoring adverse events and laboratory parameters. Results A total 18 treatment-naïve CHC patients on MHD were recruited. And 14 of them underwent MHD for primary chronic glomerulonephritis. All of them were of HCV genotype 1b. One patient developed compensated cirrhosis. The average time of HCV infection was (150.6±47.6)month. Baseline HCV-RNA ranged from (4.61×106 )U/L to (4.47×109)U/L. And 12-week SOF/VEL treatment was completed and HCV-RNA stayed negative at EOT and PTW12/48. Significant reductions occurred in ALT [19.0(13.8, 24.0)U/L vs 9.0(8.0, 10.0)U/L] and AST [18.0(12.5, 21.0)U/L vs 10.0(8.0, 12.0)U/L] from baseline to PTW48 (P<0.05). There was a marked rise in blood platelet from baseline to PTW48 [120.0(108.3, 142.8)×109/L vs 154.0(131.0, 181.8)×109/L](P<0.05). Serum levels of potassium at EOT were comparable to baseline. The most common adverse events included pruritus, nausea and fatigue. Conclusions The above 12-week treatment of SOF/VEL is well-tolerated and highly efficacious for CHC patients on MHD. The results support the management of uncomplicated HCV cases by nephrologists. It may be scaled up to HCV elimination during MHD.
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spelling doaj.art-51a62646be8e4fbe84f91ea563d645022024-02-23T09:28:22ZzhoEditorial Department of Journal of Clinical NephrologyLinchuang shenzangbing zazhi1671-23902023-10-01231084184610.3969/j.issn.1671-2390.2023.10.00820220577Clinical outcomes of sofosbuvir/velpatasvir in hepatitis C virus-infected patients with end-stage renal disease on maintenance hemodialysisLi-xia Yu0Jian-ming Ye1Xiao-ya Yin2Qi-feng Liu3Qiang Sun4Department of Nephrology, the First People's Hospital of Kunshan, Kunshan 215300, ChinaDepartment of Nephrology, the First People's Hospital of Kunshan, Kunshan 215300, ChinaDepartment of Nephrology, the First People's Hospital of Kunshan, Kunshan 215300, ChinaDepartment of Nephrology, the First People's Hospital of Kunshan, Kunshan 215300, ChinaDepartment of Nephrology, the First People's Hospital of Kunshan, Kunshan 215300, ChinaObjective To evaluate the safety and efficacy of 12-week sofosbuvir/velpatasvir (SOF/VEL) in chronic hepatitis C (CHC) patients with end-stage renal disease (ESRD) on maintenance hemodialysis (MHD) in a real-world setting. Methods From October 10, 2020 to January 28, 2021, 18 CHC patients received full-dose sofosbuvir (400 mg) plus velpatasvir (100 mg) once daily for 12 weeks. HCV RNA quantification, hepaticorenal function and electrolytes were assessed at baseline, end of treatment (EOT) and Week 12/48 after discontinuing therapy. Primary outcome was sustained virological response at Week 12 post-treatment (SVR12, HCV RNA negative). Safety profile was evaluated by monitoring adverse events and laboratory parameters. Results A total 18 treatment-naïve CHC patients on MHD were recruited. And 14 of them underwent MHD for primary chronic glomerulonephritis. All of them were of HCV genotype 1b. One patient developed compensated cirrhosis. The average time of HCV infection was (150.6±47.6)month. Baseline HCV-RNA ranged from (4.61×106 )U/L to (4.47×109)U/L. And 12-week SOF/VEL treatment was completed and HCV-RNA stayed negative at EOT and PTW12/48. Significant reductions occurred in ALT [19.0(13.8, 24.0)U/L vs 9.0(8.0, 10.0)U/L] and AST [18.0(12.5, 21.0)U/L vs 10.0(8.0, 12.0)U/L] from baseline to PTW48 (P<0.05). There was a marked rise in blood platelet from baseline to PTW48 [120.0(108.3, 142.8)×109/L vs 154.0(131.0, 181.8)×109/L](P<0.05). Serum levels of potassium at EOT were comparable to baseline. The most common adverse events included pruritus, nausea and fatigue. Conclusions The above 12-week treatment of SOF/VEL is well-tolerated and highly efficacious for CHC patients on MHD. The results support the management of uncomplicated HCV cases by nephrologists. It may be scaled up to HCV elimination during MHD.http://www.lcszb.com/cn/article/doi/10.3969/j.issn.1671-2390.2023.10.008hemodialysishepatitis cend-stage renal disease
spellingShingle Li-xia Yu
Jian-ming Ye
Xiao-ya Yin
Qi-feng Liu
Qiang Sun
Clinical outcomes of sofosbuvir/velpatasvir in hepatitis C virus-infected patients with end-stage renal disease on maintenance hemodialysis
Linchuang shenzangbing zazhi
hemodialysis
hepatitis c
end-stage renal disease
title Clinical outcomes of sofosbuvir/velpatasvir in hepatitis C virus-infected patients with end-stage renal disease on maintenance hemodialysis
title_full Clinical outcomes of sofosbuvir/velpatasvir in hepatitis C virus-infected patients with end-stage renal disease on maintenance hemodialysis
title_fullStr Clinical outcomes of sofosbuvir/velpatasvir in hepatitis C virus-infected patients with end-stage renal disease on maintenance hemodialysis
title_full_unstemmed Clinical outcomes of sofosbuvir/velpatasvir in hepatitis C virus-infected patients with end-stage renal disease on maintenance hemodialysis
title_short Clinical outcomes of sofosbuvir/velpatasvir in hepatitis C virus-infected patients with end-stage renal disease on maintenance hemodialysis
title_sort clinical outcomes of sofosbuvir velpatasvir in hepatitis c virus infected patients with end stage renal disease on maintenance hemodialysis
topic hemodialysis
hepatitis c
end-stage renal disease
url http://www.lcszb.com/cn/article/doi/10.3969/j.issn.1671-2390.2023.10.008
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