Evidence map›Paper›PMID 24784763›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2014

HIV protective efficacy and correlates of tenofovir blood concentrations in a clinical trial of PrEP for HIV prevention.

Deborah Donnell, Jared M Baeten, Namandjé N Bumpus, Justin Brantley, David R Bangsberg, Jessica E Haberer, Andrew Mujugira, Nelly Mugo, Patrick Ndase, Craig Hendrix and 1 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2014. 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 251 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
251citing papers in PubMed, 6 pooled it
17.8field-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.

NCT04870671 early_phase1completednot on this mapstarted 2021, after this paper: background citation

Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor for Determining Adherence Using Different Dosing Regimens of Disoproxil Fumarate/Emtricitabine (TDF/FTC)

TypeinterventionalSponsorEastern Virginia Medical SchoolRan2021 to 2023Enrolled14ConditionsHIV/AIDS, Adherence, Medication, Drug UseArmsTenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)
NCT05333679 nacompletednot on this mapstarted 2022, after this paper: background citation

Urine Tenofovir Point-of-care Test to Identify Patients in Need of ART Adherence Support (UTRA Study)

TypeinterventionalSponsorUniversity of California, San FranciscoRan2022 to 2025Enrolled200ConditionsRisk ReductionArmsUTRA, UTRA feedback
3 · Its place in the literature

Who cites it

251 citing papers in PubMed, 6 syntheses or guidelines pooled it, 362 citations in OpenAlex.

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191 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

11 authors at 6 institutions in 3 countries.

Deborah Donnell*Department of Global Health University of Washington and Vaccine and Infectious Disease Institute Fred Hutchinson Cancer Research Center, Seattle, WA; Departments of †Global Health; ‡Medicine; §Epidemiology, University of Washington, Seattle, WA; Departments of ‖Pharmacology and Molecular Sciences; ¶Medicine, Johns Hopkins University, Baltimore, MD; #Center for Global Health, Massachusetts General Hospital and Department of Medicine, Harvard Medical School, Boston, MA; **Department of Medicine, Mbarara University of Science and Technology, Mbarara, Uganda; ††Department of Obstetrics and Gynecology, University of Nairobi and Kenyatta National Hospital, Nairobi; and ‡‡Department of Epidemiology, Johns Hopkins University, Baltimore, MD.
Jared M Baeten
Namandjé N Bumpus
Justin Brantley
David R Bangsberg
Jessica E Haberer
Andrew Mujugira
Nelly Mugo
Patrick Ndase
Craig Hendrix
Connie Celum
Johns Hopkins University · USUniversity of Washington · USCenter for Global Health · USFred Hutch Cancer Center · USMassachusetts General Hospital · USUniversity of Nairobi · KE

Funding

Evaluation of antiretroviral HIV prevention in African HIV discordant couplesR21NR012663 · NINR · UNIVERSITY OF WASHINGTON · PI BAETEN, JARED · 2011 to 2012
$376k
NINR NIH HHS R21 NR012663
6 · The paper itself

Abstract

backgroundAntiretroviral pre-exposure prophylaxis (PrEP) is a novel HIV prevention strategy for which adherence is a known determinant of efficacy. Blood concentrations of PrEP medications are one objective marker of adherence.

methodsIn a placebo-controlled PrEP efficacy trial of tenofovir disoproxil fumarate (TDF) and TDF with emtricitabine (FTC/TDF) among 4747 African women and men with an HIV-infected partner, we measured plasma tenofovir concentrations from participants in the active PrEP arms: 29 HIV seroconverters (cases) and 196 randomly selected controls who remained uninfected.

resultsAmong controls, 71% of visits had tenofovir concentrations >40 ng/mL, consistent with steady-state daily dosing, compared with 21% of cases at the visit HIV was first detected. Pill count data indicated that 96% of controls and 66% of cases had >80% adherence for these same visits. The estimated protective effect of PrEP against HIV, based on concentrations >40 ng/mL, was 88% (95% confidence interval: 60 to 96, P < 0.001) for individuals receiving TDF and 91% (95% confidence interval: 47 to 98, P = 0.008) for individuals receiving FTC/TDF. Controls had consistent patterns of PrEP concentrations during follow-up; among the 81% with concentrations >40 ng/mL at month 1, 75% maintained this concentration at month 12. Only 5 of 29 seroconverters seemed to be consistently adherent to PrEP. Tenofovir concentrations >40 ng/mL were associated with older age and shorter time on study; concentrations ≤40 ng/mL occurred more commonly when participants reported no sex with their HIV-infected partner.

conclusionsPlasma concentrations of tenofovir consistent with daily dosing were highly predictive of protection from HIV acquisition. Most of those who took PrEP seemed to have high and consistent adherence.

Indexed as

AdenineAdultAnti-HIV AgentsBiomarkersCohort StudiesDeoxycytidineDrug MonitoringDrug Therapy, CombinationEmtricitabineFemaleHIV InfectionsHIV SeropositivityHumansMaleOrganophosphonatesPredictive Value of TestsAdenineAnti-HIV AgentsBiomarkersDeoxycytidineEmtricitabineOrganophosphonatesTenofovir

Identifiers

PMID24784763
PMCPMC4059553
OpenAlexW2172212902

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.