2024-03-29T10:15:01Zhttp://digital.csic.es/dspace-oai/requestoai:digital.csic.es:10261/2133412020-06-05T01:10:45Zcom_10261_11773com_10261_1col_10261_11774
DIGITAL.CSIC
author
Borgia, Sergio M.
author
Dearden, Janet
author
Yoshida, Eric M.
author
Shafran, Stephen D.
author
Brown, Ashley
author
Ben-Ari, Ziv
author
Cramp, Matthew E.
author
Cooper, Curtis
author
Foxton, Matthew
author
Fernández-Rodríguez, Conrado M.
author
Esteban, Rafael
author
Hyland, Robert
author
Lu, Sophia
author
Kirby, Brian J.
author
Meng, Amy
author
Markova, Svetlana
author
Dvory-Sobol, Hadas
author
Osinusi, Anu O.
author
Bruck, Rafael
author
Ampuero, Javier
author
Ryder, Stephen D.
author
Agarwal, Kosh
author
Fox, Raymond
author
Shaw, David
author
Haider, Shariq
author
Willems, Bernard
author
Lurie, Yoav
author
Calleja, José Luis
author
Gane, Edward J.
2020-06-04T09:49:05Z
2020-06-04T09:49:05Z
2019-10
Journal of Hepatology 71(4): 660-665 (2019)
0168-8278
http://hdl.handle.net/10261/213341
10.1016/j.jhep.2019.05.028
[Background & Aims] Although off-label use of sofosbuvir-containing regimens occurs regularly in patients with hepatitis C virus (HCV) infection undergoing dialysis for severe renal impairment or end-stage renal disease (ESRD), these regimens are not licensed for this indication, and there is an absence of dosing recommendations in this population. This study evaluated the safety and efficacy of sofosbuvir/velpatasvir in patients with HCV infection with ESRD undergoing dialysis.
[Methods] In this phase II, single-arm study, 59 patients with genotype 1–6 HCV infection with ESRD undergoing hemodialysis or peritoneal dialysis received open-label sofosbuvir/velpatasvir (400 mg/100 mg) once daily for 12 weeks. Patients were HCV treatment naive or treatment experienced without cirrhosis or with compensated cirrhosis. Patients previously treated with any HCV NS5A inhibitor were not eligible. The primary efficacy endpoint was the proportion of patients achieving sustained virologic response (SVR) 12 weeks after discontinuation of treatment (SVR12). The primary safety endpoint was the proportion of patients who discontinued study drug due to adverse events.
[Results] Overall, 56 of 59 patients achieved SVR12 (95%; 95% CI 86–99%). Of the 3 patients who did not achieve SVR12, 2 patients had virologic relapse determined at post-treatment Week 4 (including 1 who prematurely discontinued study treatment), and 1 patient died from suicide after achieving SVR through post-treatment Week 4. The most common adverse events were headache (17%), fatigue (14%), nausea (14%), and vomiting (14%). Serious adverse events were reported for 11 patients (19%), and all were deemed to be unrelated to sofosbuvir/velpatasvir.
[Conclusions] Treatment with sofosbuvir/velpatasvir for 12 weeks was safe and effective in patients with ESRD undergoing dialysis.
[Lay summary] Sofosbuvir/velpatasvir is a combination direct-acting antiviral that is approved for treatment of patients with hepatitis C virus (HCV) infection. Despite the lack of dosing recommendations, sofosbuvir-containing regimens (including sofosbuvir/velpatasvir) are frequently used for HCV-infected patients undergoing dialysis. This study evaluated the safety and efficacy of sofosbuvir/velpatasvir for 12 weeks in patients with HCV infection who were undergoing dialysis. Treatment with sofosbuvir/velpatasvir was safe and well tolerated, resulting in a cure rate of 95% in patients with HCV infection and end-stage renal disease.
Clinical Trial Number: NCT03036852.
eng
openAccess
Direct-acting antiviral
ESRD
Severe renal impairment
Chronic hepatitis C infection
HCV, SVR12, drug safety
Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis
artículo
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URL
https://digital.csic.es/bitstream/10261/213341/1/1-s2.0-S0168827819303435-main.pdf
File
MD5
8c08709391fadecc72dfdf50da5e4f4b
620551
application/pdf
1-s2.0-S0168827819303435-main.pdf