Evidence map›Paper›PMID 30697570›Full record

ArticleOpen forum infectious diseases2019

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

Austin Chan, Lawrence Park, Lauren F Collins, Curtis Cooper, Michael Saag, Douglas Dieterich, Mark Sulkowski, Susanna Naggie

Open access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 7 institutions in 2 countries.

Austin ChanDuke Clinical Research Institute, Durham, North Carolina.ORCID 0000-0002-6839-1832
Lawrence ParkDuke University School of Medicine, Durham, North Carolina.
Lauren F CollinsEmory University School of Medicine, Atlanta, Georgia.
Curtis CooperUniversity of Ottawa, The Ottawa Hospital, Ottawa, Ontario, Canada.
Michael SaagUniversity of Alabama at Birmingham, Birmingham, Alabama.
Douglas DieterichIcahn School of Medicine at Mount Sinai, New York, New York.
Mark SulkowskiJohns Hopkins University School of Medicine, Baltimore, Maryland.
Susanna NaggieDuke Clinical Research Institute, Durham, North Carolina.
Clinical Research Institute · USDuke University · USEmory University · USIcahn School of Medicine at Mount Sinai · USJohns Hopkins University · USUniversity of Alabama at Birmingham · USUniversity of Ottawa · CA

Funding

Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE)UL1TR002378 · NCATS · EMORY UNIVERSITY · PI Andres J Garcia, Elizabeth O. Ofili · 2017 to 2026
$92.1M
Social and Behavioral Sciences CoreP30AI064518 · NIAID · DUKE UNIVERSITY · PI GEORGIA Doris TOMARAS · 2005 to 2026
$50.5M
J: NRSA Training CoreTL1TR002382 · NCATS · EMORY UNIVERSITY · PI HENRY M BLUMBERG, Vasiliki Michopoulos · 2017 to 2026
$8.5M
NCATS NIH HHS TL1 TR002382NCATS NIH HHS UL1 TR002378NIAID NIH HHS P30 AI064518
6 · The paper itself

Abstract

backgroundConcomitant 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.

methodsThe 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+).

resultsThree 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.

conclusionsTFV 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.

Indexed as

hepatitis CHIVledipasvirtenofovirurinary biomarkers

Identifiers

PMID30697570
PMCPMC6344926
OpenAlexW2914442791

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.