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Real world SOF/VEL/VOX retreatment outcomes and viral resistance analysis for HCV patients with prior failure to DAA therapy

Smith, David A; Bradshaw, Daniel; Mbisa, Jean; Manso, Carmen F; Bibby, David; Singer, Josh; Thomson, Emma C.; Filipe, Ana; Aranday‐Cortes, Elihu; Ansari, M. Azim; Brown, Anthony; Hudson, Emma; Benselin, Jennifer; Healy, Brendan; Troke, Phil; McLauchlan, John; Barnes, Eleanor; Irving, William L.

Real world SOF/VEL/VOX retreatment outcomes and viral resistance analysis for HCV patients with prior failure to DAA therapy Thumbnail


Authors

David A Smith

Daniel Bradshaw

Jean Mbisa

Carmen F Manso

David Bibby

Josh Singer

Emma C. Thomson

Ana Filipe

Elihu Aranday‐Cortes

M. Azim Ansari

Anthony Brown

Emma Hudson

Jennifer Benselin

Brendan Healy

Phil Troke

John McLauchlan

Eleanor Barnes

William L. Irving



Abstract

Sustained viral response (SVR) rates for direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) infection routinely exceed 95%. However, a small number of patients require retreatment. Sofosbuvir, velpatasvir and voxilaprevir (SOF/VEL/VOX) is a potent DAA combination primarily used for the retreatment of patients who failed by DAA therapies. Here we evaluate retreatment outcomes and the effects of resistance-associated substitutions (RAS) in a real-world cohort, including a large number of genotype (GT)3 infected patients. 144 patients from the UK were retreated with SOF/VEL/VOX following virologic failure with first-line DAA treatment regimens. Full-length HCV genome sequencing was performed prior to retreatment with SOF/VEL/VOX. HCV subtypes were assigned and RAS relevant to each genotype were identified. GT1a and GT3a each made up 38% (GT1a n=55, GT3a n=54) of the cohort. 40% (n=58) of patients had liver cirrhosis of whom 7% (n=4) were decompensated, 10% (n=14) had hepatocellular carcinoma (HCC) and 8% (n=12) had received a liver transplant prior to retreatment. The overall retreatment SVR12 rate was 90% (129/144). On univariate analysis, GT3 infection (50/62; SVR=81%, p=.009), cirrhosis (47/58; SVR=81%, p=.01) and prior treatment with SOF/VEL (12/17; SVR=71%, p=.02) or SOF+DCV (14/19; SVR=74%, p=.012) were significantly associated with retreatment failure, but existence of pre-retreatment RAS was not when viral genotype was taken into account. Retreatment with SOF/VEL/VOX is very successful for non-GT3-infected patients. However, for GT3-infected patients, particularly those with cirrhosis and failed by initial SOF/VEL treatment, SVR rates were significantly lower and alternative retreatment regimens should be considered.

Citation

Smith, D. A., Bradshaw, D., Mbisa, J., Manso, C. F., Bibby, D., Singer, J., Thomson, E. C., Filipe, A., Aranday‐Cortes, E., Ansari, M. A., Brown, A., Hudson, E., Benselin, J., Healy, B., Troke, P., McLauchlan, J., Barnes, E., & Irving, W. L. (2021). Real world SOF/VEL/VOX retreatment outcomes and viral resistance analysis for HCV patients with prior failure to DAA therapy. Journal of Viral Hepatitis, 28(9), 1256-1264. https://doi.org/10.1111/jvh.13549

Journal Article Type Article
Acceptance Date May 5, 2021
Online Publication Date May 18, 2021
Publication Date 2021-09
Deposit Date Aug 13, 2021
Publicly Available Date Aug 13, 2021
Journal Journal of Viral Hepatitis
Print ISSN 1352-0504
Electronic ISSN 1365-2893
Publisher Wiley
Peer Reviewed Peer Reviewed
Volume 28
Issue 9
Pages 1256-1264
DOI https://doi.org/10.1111/jvh.13549
Keywords Hepatology; Virology; Infectious Diseases
Public URL https://nottingham-repository.worktribe.com/output/5619919
Publisher URL https://onlinelibrary.wiley.com/doi/10.1111/jvh.13549

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