Evidence map›Paper›PMID 27742226›Full record

Trial reportEBioMedicine2016

Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide.

Nicholas T Funderburg, Grace A McComsey, Manjusha Kulkarni, Tammy Bannerman, Jessica Mantini, Bernadette Thornton, Hui C Liu, Yafeng Zhang, Qinghua Song, Liang Fang and 5 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in EBioMedicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT01780506 phase3completednot on this map

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

TypeinterventionalSponsorGilead SciencesRan2012 to 2017Enrolled872ConditionsHIV, HIV InfectionsArmsE/C/F/TAF, E/C/F/TDF, E/C/F/TDF Placebo, E/C/F/TAF Placebo
NCT01797445 phase3completednot on this map

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

TypeinterventionalSponsorGilead SciencesRan2013 to 2018Enrolled872ConditionsHIV, HIV InfectionsArmsE/C/F/TAF, E/C/F/TDF, E/C/F/TDF Placebo, E/C/F/TAF Placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Observational
  12. Article
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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

15 authors.

Nicholas T FunderburgSchool of Health and Rehabilitation Sciences, Division of Medical Laboratory Science, Ohio State University, Columbus, OH 43210, USA. Electronic address: nicholas.funderburg@osumc.edu.
Grace A McComseyCase Western Reserve University, Cleveland, OH 44106, USA; Rainbow Babies and Children's Hospital, University Hospitals Case Medical Center, Cleveland, OH, 44106, USA.
Manjusha KulkarniSchool of Health and Rehabilitation Sciences, Division of Medical Laboratory Science, Ohio State University, Columbus, OH 43210, USA.
Tammy BannermanSchool of Health and Rehabilitation Sciences, Division of Medical Laboratory Science, Ohio State University, Columbus, OH 43210, USA.
Jessica MantiniSchool of Health and Rehabilitation Sciences, Division of Medical Laboratory Science, Ohio State University, Columbus, OH 43210, USA.
Bernadette ThorntonSchool of Health and Rehabilitation Sciences, Division of Medical Laboratory Science, Ohio State University, Columbus, OH 43210, USA.
Hui C LiuGilead Sciences Inc., Foster City, CA 94404, USA.
Yafeng ZhangGilead Sciences Inc., Foster City, CA 94404, USA.
Qinghua SongGilead Sciences Inc., Foster City, CA 94404, USA.
Liang FangGilead Sciences Inc., Foster City, CA 94404, USA.
Jason DinosoGilead Sciences Inc., Foster City, CA 94404, USA.
Andrew ChengGilead Sciences Inc., Foster City, CA 94404, USA.
Scott McCallisterGilead Sciences Inc., Foster City, CA 94404, USA.
Marshall W FordyceGilead Sciences Inc., Foster City, CA 94404, USA.
Moupali DasGilead Sciences Inc., Foster City, CA 94404, USA.

Funding

WG3: HIV, Co-infections and Co-morbiditiesP30AI036219 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI Sharon L. Hillier, JONATHAN KARN · 1994 to 2026
$50.0M
NIAID NIH HHS P30 AI036219
6 · The paper itself

Abstract

backgroundInitiation of antiretroviral therapy (ART) and subsequent virologic suppression reduces immune activation and systemic inflammation.

methodsWe examined longitudinal changes in biomarkers of monocyte activation (sCD14, sCD163), and systemic (IL-6, hsCRP, sTNFR-I and D-dimer) and vascular (Lp-PLA

resultsFor 194 participants (TAF, 98; TDF, 96), baseline levels of biomarkers did not differ by treatment arm; there were no differences in biomarker values between groups at weeks 12, 24, or 48 (p>0.05), except IL-6 at week 12 (p=0.012). Among all participants (combining groups), there were statistically significant declines from baseline observed for D-dimer, sCD163, and sTNFR-1 by week 12 and IL-6 by week 24. The proportion of participants with Lp-LA

conclusionsWe observed equivalent declines in biomarkers of monocyte activation and systemic inflammation in treatment-naïve adults treated with TAF or TDF for 48weeks, suggesting that TAF and TDF have equivalent impact on immune activation and inflammation.

Indexed as

HIV-1AdenineAdultAlanineAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveBiomarkersComorbidityFemaleHIV InfectionsHumansInflammation MediatorsMaleROC CurveTenofovirAdenineAlanineAnti-HIV AgentsBiomarkersInflammation MediatorsTenofovirtenofovir alafenamideBiomarkersImmune activationInflammationTenofovir alafenamide

Identifiers

PMID27742226
PMCPMC5264242

What OpenQuestion holds

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Read underepoch 390

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.