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Correlation Between Tenofovir Drug Levels and the Renal Biomarkers RBP-4 and ß2M in the ION-4 Study Cohort.

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Date
2019-01
Authors
Chan, Austin
Park, Lawrence
Collins, Lauren F
Cooper, Curtis
Saag, Michael
Dieterich, Douglas
Sulkowski, Mark
Naggie, Susanna
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Abstract
<h4>Background</h4>Concomitant dosing of ledipasvir (LDV) and tenofovir disoproxil fumarate (TDF) results in an increased tenofovir (TFV) area under the curve (AUC). The aim of this study was to examine whether there was a correlation between the renal biomarkers retinol binding protein-4 (RBP-4) and β2 microglobulin (β2M) and tenofovir AUC.<h4>Methods</h4>The ION-4 trial enrolled HIV/hepatitis C virus-coinfected patients on nonpharmacologically boosted antiretroviral regimens with TDF-containing backbones. We assessed for a correlation between tenofovir AUC and urinary biomarkers and also for changes in serologic biomarkers with respect to clinically relevant changes in renal function (creatinine clearance decrease >25%, change in creatinine >0.2 mg/dL, change in proteinuria from negative/trace to ≥1+).<h4>Results</h4>Three hundred thirty-five patients were enrolled in the ION-4 study; their demographic characteristics have been previously described. Both RBP-4 and β2M exhibited positive correlations with tenofovir AUC. Baseline and study levels of RBP-4 and β2M were higher for patients with increases in urine proteinuria and an absolute creatinine increase.<h4>Conclusions</h4>TFV exposure is associated with increased proximal tubule urine biomarkers in participants on ledipasvir/sofosbuvir and nonpharmacologically boosted TDF-based antiretroviral regimens. Baseline proximal tubule biomarkers may predict nephrotoxicity risk if events are prevalent. Further studies assessing the predictive role of these urine biomarkers may help guide medical decision-making and risk/benefit assessments in patients with risk factors for renal dysfunction.
Type
Journal article
Subject
HIV
hepatitis C
ledipasvir
tenofovir
urinary biomarkers
Permalink
https://hdl.handle.net/10161/26434
Published Version (Please cite this version)
10.1093/ofid/ofy273
Publication Info
Chan, Austin; Park, Lawrence; Collins, Lauren F; Cooper, Curtis; Saag, Michael; Dieterich, Douglas; ... Naggie, Susanna (2019). Correlation Between Tenofovir Drug Levels and the Renal Biomarkers RBP-4 and ß2M in the ION-4 Study Cohort. Open forum infectious diseases, 6(1). pp. ofy273. 10.1093/ofid/ofy273. Retrieved from https://hdl.handle.net/10161/26434.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Naggie

Susanna Naggie

Professor of Medicine
Dr. Susanna Naggie completed her medical education at Johns Hopkins School of Medicine and her internal medicine training at Duke University Medical Center (DUMC), where she also served as a Chief Resident in Internal Medicine.  She completed her Infectious Diseases (ID) fellowship training at Duke and then joined the faculty in the Division of ID. She is a Professor of Medicine and currently holds joint appointments at the Duke Clinical Research Institute and at the Durham Veterans Affa
Park

Lawrence P Park

Associate Professor in Medicine
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