Evidence map›Paper›PMID 30932951›Full record

ArticleAIDS (London, England)2019

Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials.

Samir K Gupta, Frank A Post, José R Arribas, Joseph J Eron, David A Wohl, Amanda E Clarke, Paul E Sax, Hans-Jürgen Stellbrink, Stefan Esser, Anton L Pozniak and 14 more

3 registry-linked trialsOpen access · hybridAbstract readComparative Study
In one paragraph

Article in AIDS (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 94 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 2 pooled it
11.0field-weighted citation impact, top 1% 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.

NCT01815736 phase3completednot on this map

A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects

TypeinterventionalSponsorGilead SciencesRan2013 to 2020Enrolled1,443ConditionsHIV, HIV InfectionsArmsE/C/F/TAF, E/C/F/TDF, EFV/FTC/TDF, RTV, ATV
NCT02469246 phase3completednot on this map

A Phase 3b, Randomized, Double-Blind, Switch Study to Evaluate F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed on Regimens Containing ABC/3TC

TypeinterventionalSponsorGilead SciencesRan2015 to 2019Enrolled567ConditionsHIV-1 InfectionArmsF/TAF, ABC/3TC, ABC/3TC Placebo, F/TAF Placebo, 3rd ARV agent
NCT02607956 phase3completednot on this map

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

TypeinterventionalSponsorGilead SciencesRan2015 to 2021Enrolled657ConditionsHIV-1 InfectionArmsDTG, F/TAF, B/F/TAF, DTG Placebo, F/TAF Placebo
3 · Its place in the literature

Who cites it

94 citing papers in PubMed, 2 syntheses or guidelines pooled it, 158 citations in OpenAlex.

  1. Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV - CDC Recommendations, United States, 2025.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2025
    Guideline
  2. Pooled it
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34 more citing papers are in PubMed but not listed here.

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

24 authors at 15 institutions in 5 countries.

Samir K GuptaDepartment of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Frank A PostKing's College Hospital NHS Foundation Trust, London, UK.
José R ArribasInstituto de Investigación Hospital Universitario La Paz, Hospital Universitario La Paz, Madrid, Spain.
Joseph J EronDivision of Infectious Diseases, Department of Medicine, UNC School of Medicine.
David A WohlDivision of Infectious Diseases, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Amanda E ClarkeSexual Health and Clinical Trials, Royal Sussex County Hospital, Brighton, UK.
Paul E SaxBrigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Hans-Jürgen StellbrinkInfectious Disease Medical Center, Hamburg.
Stefan EsserUniversitatsklinikum, Essen, Germany.
Anton L PozniakChelsea and Westminster Hospital and St Stephens AIDS Trust, London, UK.
Daniel PodzamczerInfectious Diseases Service, Hospital Universitario de Bellvitge, Barcelona, Spain.
Laura WatersMortimer Market Centre.
Chloe OrkinBarts Health NHS Trust, Ambrose King Centre, Royal London Hospital, London, UK.
Jürgen K RockstrohUniversity Hospital Bonn, Bonn, Germany.
Tatiana MudrikovaDepartment of Internal Medicine and Infectious Diseases, University Medical Center Utrecht, Utrecht, The Netherlands.
Eugenia NegredoUniversitat de Vic-Universitat Central de Catalunya, Barcelona, Spain.
Richard A ElionDepartment of Clinical Investigations, Whitman-Walker Health, Washington, District of Columbia.
Susan GuoDepartments of Biometrics and HIV & Emerging Viral Infections Clinical Research, Gilead Sciences, Inc., Foster City, California, USA.
Lijie ZhongDepartments of Biometrics and HIV & Emerging Viral Infections Clinical Research, Gilead Sciences, Inc., Foster City, California, USA.
Christoph CarterDepartments of Biometrics and HIV & Emerging Viral Infections Clinical Research, Gilead Sciences, Inc., Foster City, California, USA.
Hal MartinDepartments of Biometrics and HIV & Emerging Viral Infections Clinical Research, Gilead Sciences, Inc., Foster City, California, USA.
Diana BrainardDepartments of Biometrics and HIV & Emerging Viral Infections Clinical Research, Gilead Sciences, Inc., Foster City, California, USA.
Devi SenGuptaDepartments of Biometrics and HIV & Emerging Viral Infections Clinical Research, Gilead Sciences, Inc., Foster City, California, USA.
Moupali DasDepartments of Biometrics and HIV & Emerging Viral Infections Clinical Research, Gilead Sciences, Inc., Foster City, California, USA.
Bellvitge University Hospital · ESBrigham and Women's Hospital · USChelsea and Westminster Hospital · GBEssen University Hospital · DEHospital Universitario La Paz · ESIndiana University School of MedicineKing's College Hospital NHS Foundation Trust · GBMortimer Market Centre · GBRoyal London Hospital · GBRoyal Sussex County Hospital · GBUniversitat de Vic - Universitat Central de Catalunya · ESUniversity Hospital Bonn · DEUniversity Medical Center Utrecht · NLUniversity of North Carolina at Chapel Hill · USWhitman-Walker Health · US

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
NIAID NIH HHS P30 AI050410
6 · The paper itself

Abstract

objectiveCompared with tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF) has been associated with improvement in markers of renal dysfunction in individual randomized trials; however, the comparative incidence of clinically significant renal events remains unclear.

designWe used a pooled data approach to increase the person-years of drug exposure analysed, maximizing our ability to detect differences in clinically significant outcomes.

methodsWe pooled clinical renal safety data across 26 treatment-naive and antiretroviral switch studies to compare the incidence of proximal renal tubulopathy and discontinuation due to renal adverse events between participants taking TAF-containing regimens vs. those taking TDF-containing regimens. We performed secondary analyses from seven large randomized studies (two treatment-naive and five switch studies) to compare incidence of renal adverse events, treatment-emergent proteinuria, changes in serum creatinine, creatinine clearance, and urinary biomarkers (albumin, beta-2-microglobulin, and retinol binding protein-to-creatinine ratios).

resultsOur integrated analysis included 9322 adults and children with HIV (n = 6360 TAF, n = 2962 TDF) with exposure of 12 519 person-years to TAF and 5947 to TDF. There were no cases of proximal renal tubulopathy in participants receiving TAF vs. 10 cases in those receiving TDF (P < 0.001), and fewer individuals on TAF (3/6360) vs. TDF (14/2962) (P < 0.001) discontinued due to a renal adverse event. Participants initiating TAF-based vs. TDF-based regimens had more favourable changes in renal biomarkers through 96 weeks of therapy.

conclusionThese pooled data from 26 studies, with over 12 500 person-years of follow-up in children and adults, support the comparative renal safety of TAF over TDF.

Indexed as

AdenineAdolescentAdultAgedAged, 80 and overAlanineAnti-HIV AgentsChildFemaleHumansIncidenceMaleMiddle AgedRenal InsufficiencyTenofovirYoung AdultAdenineAlanineAnti-HIV AgentsTenofovirtenofovir alafenamide

Identifiers

PMID30932951
PMCPMC6635043
OpenAlexW2928530166

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.