Evidence map›Paper›PMID 27673443›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2017

Brief Report: Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Adults With Renal Impairment: 96-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study.

Frank A Post, Pablo Tebas, Amanda Clarke, Laurent Cotte, William R Short, Michael E Abram, Shuping Jiang, Andrew Cheng, Moupali Das, Marshall W Fordyce

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01818596 (A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients With Mild to Moderate Renal Impairment), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing 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.

NCT01818596 phase3completednot on this map

A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

TypeinterventionalSponsorGilead SciencesRan2013 to 2018Enrolled252ConditionsHIV, HIV InfectionsArmsE/C/F/TAF
3 · Its place in the literature

Who cites it

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

  1. Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Metabolic Effects of Preexposure Prophylaxis With Coformulated Tenofovir Disoproxil Fumarate and Emtricitabine.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Trial
  6. Trial
  7. Review
  8. Article
  9. Review
  10. Review
  11. Observational
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Genetic Testing in Clinical Settings.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2018
    Review
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

10 authors.

Frank A Post*Department of Sexual Health, King's College Hospital NHS Foundation Trust, London, United Kingdom; †Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; ‡Department of Sexual Health, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom; §Department of Infectious Diseases, Croix-Rousse Hospital, Hospices Civils de Lyon, France; and ‖Gilead Sciences, Inc., Foster City, CA.
Pablo Tebas
Amanda Clarke
Laurent Cotte
William R Short
Michael E Abram
Shuping Jiang
Andrew Cheng
Moupali Das
Marshall W Fordyce

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tenofovir disoproxil fumarate is associated with renal and bone toxicity. In a single-arm, open-label study of 242 virologically suppressed, HIV-infected participants with creatinine clearance 30-69 mL/min who switched to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, participants had stable creatinine clearance, significant and durable improvements in proteinuria, albuminuria, and tubular proteinuria (P < 0.001), and significant increases in hip and spine bone mineral density through 96 weeks (P < 0.001). Eighty-eight percent maintained HIV-1 RNA <50 c/mL at week 96. These longer-term results support the use of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in HIV-infected individuals with mild-moderately impaired renal function.

Indexed as

AdolescentAdultAgedAged, 80 and overAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveCreatinineHIV InfectionsHumansKidney Function TestsMaleMetabolic Clearance RateMiddle AgedProteinuriaRenal InsufficiencySustained Virologic ResponseAnti-HIV AgentsCreatinine

Identifiers

PMID27673443
PMCPMC5228610

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.