Evidence map›Paper›PMID 37969014›Full record

Trial reportThe Journal of infectious diseases2024

HIV Prevention Among Men Who Have Sex With Men: Tenofovir Alafenamide Combination Preexposure Prophylaxis Versus Placebo.

Paul N Zivich, Stephen R Cole, Jessie K Edwards, David V Glidden, Moupali Das, Bonnie E Shook-Sa, Yongwu Shao, Megha L Mehrotra, Adaora A Adimora, Joseph J Eron

2 registry-linked trialsOpen access · greenAbstract readEquivalence TrialRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2024. 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 46% 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.

NCT00458393 phase3completednot on this map

Chemoprophylaxis for HIV Prevention in Men

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2007 to 2014Enrolled2,499ConditionsHIV InfectionsArmsdaily TDF/FTC, Placebo
NCT02842086 phase3active not recruitingnot on this map

A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

TypeinterventionalSponsorGilead SciencesRan2016 to 2026Enrolled5,399ConditionsPre-Exposure Prophylaxis of HIV-1 InfectionArmsF/TAF, F/TDF, F/TAF Placebo, F/TDF Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Article
  2. 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

10 authors at 3 institutions in 1 country.

Paul N ZivichDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.ORCID 0000-0002-9932-1095
Stephen R ColeDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Jessie K EdwardsDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.ORCID 0000-0002-1741-335X
David V GliddenDepartment of Epidemiology and Biostatistics, University of California, San Francisco, California, USA.ORCID 0000-0001-5888-1419
Moupali DasGilead Sciences, Foster City, California, USA.
Bonnie E Shook-SaDepartment of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.ORCID 0000-0001-9506-4047
Yongwu ShaoGilead Sciences, Foster City, California, USA.
Megha L MehrotraDepartment of Epidemiology and Biostatistics, University of California, San Francisco, California, USA.
Adaora A AdimoraDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.ORCID 0000-0001-5035-1552
Joseph J EronDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.ORCID 0000-0002-4938-0644
University of North Carolina at Chapel Hill · USGilead Sciences (United States) · USUniversity of California, San Francisco · US

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Chemoprophylaxis for HIV Prevention in Men SupplementU01AI064002 · NIAID · J. DAVID GLADSTONE INSTITUTES · PI GRANT, ROBERT M. · 2005 to 2011
$41.3M
Chemoprophylaxis and HIV-Host InteractionsR01AI062333 · NIAID · J. DAVID GLADSTONE INSTITUTES · PI GRANT, ROBERT M. · 2004 to 2011
$6.2M
Improved analysis of experiments and observational studies in HIVR01AI157758 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Stephen R Cole, Jessie Edwards · 2020 to 2026
$5.0M
From Biological to Social Processes: Interdisciplinary Training in Life Course ResearchT32HD091058 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ROBERT A HUMMER, Amanda L Thompson · 2017 to 2026
$4.3M
Statistical methods for clinical trials of novel PrEP agentsR01AI143357 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GLIDDEN, DAVID V. · 2018 to 2021
$483k
NIAID NIH HHS P30 AI050410NIAID NIH HHS R01 AI062333NIAID NIH HHS R01 AI143357NIAID NIH HHS R01 AI157758NIAID NIH HHS U01 AI064002NICHD NIH HHS T32 HD091058NIH HHS U01-AI64002
6 · The paper itself

Abstract

backgroundWhile noninferiority of tenofovir alafenamide and emtricitabine (TAF/FTC) as preexposure prophylaxis (PrEP) for the prevention of human immunodeficiency virus (HIV) has been shown, interest remains in its efficacy relative to placebo. We estimate the efficacy of TAF/FTC PrEP versus placebo for the prevention of HIV infection.

methodsWe used data from the DISCOVER and iPrEx trials to compare TAF/FTC to placebo. DISCOVER was a noninferiority trial conducted from 2016 to 2017. iPrEx was a placebo-controlled trial conducted from 2007 to 2009. Inverse probability weights were used to standardize the iPrEx participants to the distribution of demographics and risk factors in the DISCOVER trial. To check the comparison, we evaluated whether risk of HIV infection in the shared tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) arms was similar.

resultsNotable differences in demographics and risk factors occurred between trials. After standardization, the difference in risk of HIV infection between the TDF/FTC arms was near zero. The risk of HIV with TAF/FTC was 5.8 percentage points lower (95% confidence interval [CI], -2.0% to -9.6%) or 12.5-fold lower (95% CI, .02 to .31) than placebo standardized to the DISCOVER population.

conclusionsThere was a reduction in HIV infection with TAF/FTC versus placebo across 96 weeks of follow-up. CLINICAL TRIALS REGISTRATION: NCT02842086 and NCT00458393.

Indexed as

Anti-HIV AgentsHIV InfectionsPre-Exposure ProphylaxisSexual and Gender MinoritiesAdenineEmtricitabineHIVHomosexuality, MaleHumansMaleTenofovirAdenineAnti-HIV AgentsEmtricitabineTenofovirbridged comparisoncounterfactual placeboHIVindirect comparisonsPrEPtenofovir

Identifiers

PMID37969014
PMCPMC11011171
OpenAlexW4388737347

What OpenQuestion holds

Textmetadata
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.