Evidence map›Paper›PMID 22972843›Full record

Trial reportScience translational medicine2012

Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men.

Peter L Anderson, David V Glidden, Albert Liu, Susan Buchbinder, Javier R Lama, Juan Vicente Guanira, Vanessa McMahan, Lane R Bushman, Martín Casapía, Orlando Montoya-Herrera and 8 more

7 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Science translational medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 650 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
650citing papers in PubMed, 3 pooled it
27.3field-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.

NCT00903084 phase1completednot on this map

A Phase 1 Pharmacokinetic Study of Varying Dosing Patterns on Tenofovir Concentrations in Hair

TypeinterventionalSponsorPublic Health Foundation Enterprises, Inc.Ran2009 to 2010Enrolled24ConditionsHIVArmsTenofovir Disoproxil Fumarate
NCT02588287 nacompletednot on this mapstarted 2015, after this paper: background citation

Effects of Sofosbuvir/Ledipasvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir

TypeinterventionalSponsorUniversity of Colorado, DenverRan2015 to 2016Enrolled14ConditionsHepatitis C and HIV CoinfectionArmsBlood draws for tenofovir PK, renal function
NCT02995005 phase1 / phase2completednot on this mapstarted 2018, after this paper: background citation

Prevention of Mother-to-child Transmission of Hepatitis B Virus: a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy

TypeinterventionalSponsorJohns Hopkins Bloomberg School of Public HealthRan2018 to 2023Enrolled98ConditionsHepatitis BArmsTenofovir Disoproxil Fumarate
NCT03043326 unknown statusnot on this mapstarted 2017, after this paper: background citation

Demonstration Project on the Feasibility to Implement a Pre-Exposure Oral Prophylaxis Program in Men Who Have Sex With Other Men and Transgender Women at Risk of Acquiring HIV

TypeobservationalSponsorAsociación Civil Impacta Salud y Educación, PeruRan2017 to 2022Enrolled1,000ConditionsHIV PreventionArmsTenofovir Disoproxil Fumarate and Emtricitabine
NCT03126370 phase4completednot on this mapstarted 2018, after this paper: background citation

Effects of Ledipasvir/Sofosbuvir Treatment on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF) in Patients With HIV.

TypeinterventionalSponsorUniversity of Colorado, DenverRan2018 to 2019Enrolled10ConditionsHepatitis C, HIV CoinfectionArmsTDF with a boosted protease inhibitor, TAF with a boosted protease inhibitor, TAF with a boosted protease inhibitor and LDV/SOF
NCT04048382 nacompletednot on this mapstarted 2019, after this paper: background citation

Developing a Patient Navigation Intervention for PrEP Continuum of Care Among Young Latino MSM (PrEParate)

TypeinterventionalSponsorSan Diego State UniversityRan2019 to 2021Enrolled57ConditionsHIV/AIDSArmsPatient Navigation, Usual Care
NCT04050371 phase4completednot on this mapstarted 2017, after this paper: background citation

I-BrEATHe - Interactions Between Antiretrovirals And Transgender Hormones

TypeinterventionalSponsorUniversity of California, San FranciscoRan2017 to 2018Enrolled48ConditionsHIV Prevention, Transgender HealthArms200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
3 · Its place in the literature

Who cites it

650 citing papers in PubMed, 3 syntheses or guidelines pooled it, 1,030 citations in OpenAlex.

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  12. Incentivizing adherence to pre-exposure prophylaxis for HIV prevention: a randomized pilot trial among male sex workers in Mexico.The European journal of health economics : HEPAC : health economics in prevention and care · 2025
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590 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

18 authors at 7 institutions in 3 countries.

Peter L AndersonUniversity of Colorado Denver, Aurora, CO 80045, USA.
David V Glidden
Albert Liu
Susan Buchbinder
Javier R Lama
Juan Vicente Guanira
Vanessa McMahan
Lane R Bushman
Martín Casapía
Orlando Montoya-Herrera
Valdilea G Veloso
Kenneth H Mayer
Suwat Chariyalertsak
Mauro Schechter
Linda-Gail Bekker
Esper Georges Kallás
Robert M Grant
iPrEx Study Team
Asociación Civil Impacta Salud y Educación · PEGladstone Institutes · USUniversity of California, San Francisco · USUniversity of Colorado Denver · USBrown University · USChiang Mai University · THSan Francisco Department of Public Health · US

Funding

UCSF CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTEUL1RR024131 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JOHNSTON, S. CLAIBORNE · 2006 to 2011
$111.2M
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
Cellular pharmacology of tenofovir and emtricitabine for HIV prophylaxisU01AI084735 · NIAID · UNIVERSITY OF COLORADO DENVER · PI ANDERSON, PETER L. · 2009 to 2012
$4.2M
Structural Factors and HIV and STI Incidence among Young MSM of Color in BostonU01HD068040 · NICHD · FENWAY COMMUNITY HEALTH CENTER · PI MAYER, KENNETH H · 2011 to 2015
$3.2M
Chemoprophylaxis and HIV Host InteractionsR01AI118575 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANT, ROBERT M. · 2015 to 2019
$2.9M
Hair as a Biomarker of Tenofovir Prophylactic ExposureR21MH085598 · NIMH · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI LIU, ALBERT YING-HWA · 2009 to 2010
$320k
NCRR NIH HHS UL1 RR024131NIAID NIH HHS R01 AI062333NIAID NIH HHS R01 AI118575NIAID NIH HHS U01 AI064002NIAID NIH HHS U01 AI084735NICHD NIH HHS U01 HD068040NIMH NIH HHS R21 MH085598NIMH NIH HHS R21MH085598
6 · The paper itself

Abstract

Drug concentrations associated with protection from HIV-1 acquisition have not been determined. We evaluated drug concentrations among men who have sex with men in a substudy of the iPrEx trial (1). In this randomized placebo-controlled trial, daily oral doses of emtricitabine/tenofovir disoproxil fumarate were used as pre-exposure prophylaxis (PrEP) in men who have sex with men. Drug was detected less frequently in blood plasma and in viable cryopreserved peripheral blood mononuclear cells (PBMCs) in HIV-infected cases at the visit when HIV was first discovered compared with controls at the matched time point of the study (8% versus 44%; P < 0.001) and in the 90 days before that visit (11% versus 51%; P < 0.001). An intracellular concentration of the active form of tenofovir, tenofovir-diphosphate (TFV-DP), of 16 fmol per million PBMCs was associated with a 90% reduction in HIV acquisition relative to the placebo arm. Directly observed dosing in a separate study, the STRAND trial, yielded TFV-DP concentrations that, when analyzed according to the iPrEx model, corresponded to an HIV-1 risk reduction of 76% for two doses per week, 96% for four doses per week, and 99% for seven doses per week. Prophylactic benefits were observed over a range of doses and drug concentrations, suggesting ways to optimize PrEP regimens for this population.

Indexed as

Homosexuality, MaleAdenineAnti-HIV AgentsDeoxycytidineEmtricitabineHIV InfectionsHumansMaleOrganophosphonatesTenofovirAdenineAnti-HIV AgentsDeoxycytidineEmtricitabineOrganophosphonatesTenofovir

Identifiers

PMID22972843
PMCPMC3721979
OpenAlexW2132977017

What OpenQuestion holds

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Registered trials

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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.