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dc.contributor.author
Fabrizi, Fabrizio
dc.contributor.author
Cerutti, Roberta
dc.contributor.author
Dixit, Vivek
dc.contributor.author
Ridruejo, Ezequiel
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dc.date.available
2022-09-29T11:29:57Z
dc.date.issued
2021-09
dc.identifier.citation
Fabrizi, Fabrizio; Cerutti, Roberta; Dixit, Vivek; Ridruejo, Ezequiel; Sofosbuvir-based regimens for HCV in stage 4–stage 5 chronic kidney disease. A systematic review with meta-analysis; Sociedad Española de Nefrología Dr Rafael Matesanz; Nefrología; 41; 5; 9-2021; 578-589
dc.identifier.issn
0211-6995
dc.identifier.uri
http://hdl.handle.net/11336/170894
dc.description.abstract
Background: Hepatitis C is an important agent of liver damage in patients with chronic kidney disease and the advent of DAAs has dramatically changed the management of HCV positive patients, including those with advanced CKD. Sofosbuvir is the backbone of many anti-HCV regimens based on DAAs but it remains unclear whether it is appropriate for HCV-infected patients with stage 4-5 CKD.Study aims and design: We performed a systematic review of the literature with a meta-analysis of clinical studies in order to evaluate the efficacy and safety of SOF-based DAA regimens in patients with stage 4-5 CKD. The primary outcome was sustained viral response (as a measure of efficacy); the secondary outcomes were the frequency of SAEs and drop-outs due to AEs (as measures of tolerability). The random-effects model of DerSimonian and Laird was adopted, with heterogeneity and stratified analyses.Results: Thirty clinical studies (n=1537 unique patients) were retrieved. The pooled SVR12 and SAEs rate was 0.99 (95% confidence intervals, 0.97; 1.0, I2=99.8%) and 0.09 (95% CI, 0.05; 0.13, I2=84.3%), respectively. The pooled SVR12 rate in studies with high HCV RNA levels at baseline was lower, 0.87 (95% CI, 0.75; 1.0, I2=73.3%) (P<0.001). The pooled drop-out rate due to AEs was 0.02 (95% CI, -0.01; 0.04, I2=16.1%). Common serious adverse events were anemia (n=26, 38%) and reduced eGFR (n=14, 19%). SAEs were more common in studies adopting full-dose sofosbuvir (pooled rate of SAEs 0.15, 95% CI, 0.06; 0.25; I2=80.1%) and in those based on ribavirin (0.15, 95% CI, 0.07; 0.23, I2=95.8%). Six studies (n=69 patients) reported eGFR levels at baseline/post- antiviral therapy; no consistent changes were found.Conclusions: SOF-based regimens appear safe and effective in patients with stage 4-5 CKD. Serum creatinine should be carefully monitored during therapy with SOF in patients with CKD. Randomized controlled studies in order to expand our knowledge on this point are under way.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Sociedad Española de Nefrología Dr Rafael Matesanz
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dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by/2.5/ar/
dc.subject
HCV
dc.subject
CKD
dc.subject
SOFOSBUVIR
dc.subject.classification
Gastroenterología y Hepatología
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dc.subject.classification
Medicina Clínica
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dc.subject.classification
CIENCIAS MÉDICAS Y DE LA SALUD
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dc.title
Sofosbuvir-based regimens for HCV in stage 4–stage 5 chronic kidney disease. A systematic review with meta-analysis
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2022-09-07T13:28:08Z
dc.journal.volume
41
dc.journal.number
5
dc.journal.pagination
578-589
dc.journal.pais
España
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dc.description.fil
Fil: Fabrizi, Fabrizio. Ospedale Maggiore Policlinico Milano; Italia
dc.description.fil
Fil: Cerutti, Roberta. Ospedale Maggiore Policlinico Milano; Italia
dc.description.fil
Fil: Dixit, Vivek. Ospedale Maggiore Policlinico Milano; Italia
dc.description.fil
Fil: Ridruejo, Ezequiel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. CEMIC-CONICET. Centro de Educaciones Médicas e Investigaciones Clínicas "Norberto Quirno". CEMIC-CONICET; Argentina
dc.journal.title
Nefrología
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dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://linkinghub.elsevier.com/retrieve/pii/S0211699521000916
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.1016/j.nefro.2021.01.008
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