Evidence map›Paper›PMID 38484128›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

Type 1 Human Immunodeficiency Virus (HIV-1) Incidence, Adherence, and Drug Resistance in Individuals Taking Daily Emtricitabine/Tenofovir Disoproxil Fumarate for HIV-1 Pre-exposure Prophylaxis: Pooled Analysis From 72 Global Studies.

Raphael J Landovitz, Li Tao, Juan Yang, Melanie de Boer, Christoph Carter, Moupali Das, Jared M Baeten, Albert Liu, Karen W Hoover, Connie Celum and 16 more

Open access · hybridAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
6.6field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
  2. Observational
  3. Article
  4. Article
  5. Authors' response: Addressing the blind spot of self-reported adherence in the era of long-acting PrEP.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2026
    Article
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  7. Review
  8. Observational
  9. Review
  10. Article
  11. Article
  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

26 authors at 19 institutions in 6 countries.

Raphael J LandovitzUCLA Center for Clinical AIDS Research and Education, Los Angeles, California, USA.
Li TaoGilead Sciences, Inc, Foster City, California, USA.
Juan YangGilead Sciences, Inc, Foster City, California, USA.
Melanie de BoerGilead Sciences, Inc, Foster City, California, USA.
Christoph CarterGilead Sciences, Inc, Foster City, California, USA.
Moupali DasGilead Sciences, Inc, Foster City, California, USA.
Jared M BaetenGilead Sciences, Inc, Foster City, California, USA.
Albert LiuBridge HIV, San Francisco Department of Public Health, San Francisco, California, USA.
Karen W HooverUS Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Connie CelumUniversity of Washington, Seattle, Washington, USA.
Beatriz GrinsztejnInstituto Nacional de Infectologia Evandro Chagas/Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil.
Sheldon MorrisUC San Diego Health, San Diego, California, USA.
Darrell P WheelerState University of New York, New Paltz, New York, USA.
Kenneth H MayerFenway Health and Harvard Medical School, Boston, Massachusetts, USA.
Sarit A GolubHunter College, New York, New York, USA.
Linda-Gail BekkerThe Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Souleymane DiabatéCentre de Recherche du CHU de Québec-Université Laval, Quebec, Canada.
Elske HoornenborgPublic Health Service of Amsterdam, Amsterdam, Netherlands.
Janet MyersBridge HIV, San Francisco Department of Public Health, San Francisco, California, USA.
Ashley A LeechDepartment of Health Policy, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.
Sheena McCormackMRC Clinical Trials Unit at University College London, London, United Kingdom.
Philip A ChanBrown University, Providence, Rhode Island, USA.
Michael SweatMedical University of South Carolina, Charleston, North Carolina, USA.
Lynn T MatthewsThe University of Alabama at Birmingham, Birmingham, Alabama, USA.
Robert GrantDepartment of Medicine, University of California San Francisco, San Francisco, California, USA.
Global F/TDF PrEP Study Team
Gilead Sciences (United States) · USHarvard University · USFundação Oswaldo Cruz · BRSan Francisco Department of Public Health · USSUNY New Paltz · USVanderbilt University · USAPLA Health · USBrown University · USCenters for Disease Control and Prevention · USCentre hospitalier de l'Université Laval · CADesmond Tutu HIV Foundation · ZAGGD Amsterdam · NLHunter College · USMedical University of South Carolina · USMRC Clinical Trials Unit at UCL · GBUC San Diego Health System · USUniversity of Alabama at Birmingham · USUniversity of California, San Francisco · USUniversity of Washington · US

Funding

UCLA Rapid, Relevant, Rigorous Implementation Science HubP30MH058107 · NIMH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Nina Thawata Harawa · 1997 to 2026
$53.5M
Intervention to Enhance PrEP Uptake and Adherence in a Community-Based SettingR01AA022067 · NIAAA · HUNTER COLLEGE · PI GOLUB, SARIT A · 2012 to 2016
$3.3M
PrEP Uptake/Adherence to Reduce Periconception HIV Risk for South African WomenR01MH108412 · NIMH · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI MATTHEWS, LYNN T · 2016 to 2020
$3.3M
Dyadic-Based Diagnosis, Care, & Prevention for HIV Discordant Couples in TanzaniaR01MH106369 · NIMH · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI SWEAT, MICHAEL D · 2015 to 2019
$3.0M
Medical Research Council MC_UU_00004/03NIAAA NIH HHS R01 AA022067NIH HHSNIMH NIH HHS P30 MH058107NIMH NIH HHS R01 MH106369NIMH NIH HHS R01 MH108412
6 · The paper itself

Abstract

backgroundOral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings.

methodsHIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentrations in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies.

resultsAmong 17 274 participants, there were 101 cases with new HIV-1 diagnosis (.77 per 100 person-years; 95% confidence interval [CI]: .63-.94). In 78 cases with resistance data, 18 (23%) had M184I or V, 1 (1.3%) had K65R, and 3 (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of <2, 2-3, 4-6, and ≥7 doses/wk, respectively, and the corresponding incidence was 3.9 (95% CI: 2.9-5.3), .24 (.060-.95), .27 (.12-.60), and .054 (.008-.38) per 100 person-years. Adherence was low in younger participants, Hispanic/Latinx and Black participants, cisgender women, and transgender women. Bone and renal adverse event incidence rates were 0.69 and 11.8 per 100 person-years, respectively, consistent with previous reports.

conclusionsLeveraging the largest pooled analysis of global PrEP studies to date, we demonstrate that F/TDF is safe and highly effective, even with less than daily dosing, in diverse clinical settings, geographies, populations, and routes of HIV-1 exposure.

Indexed as

Anti-HIV AgentsDrug MonitoringDrug Resistance, ViralHIV-1HIV InfectionsPre-Exposure ProphylaxisAdultEmtricitabineEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationFemaleHumansIncidenceMaleMiddle AgedProspective StudiesTenofovirAnti-HIV AgentsEmtricitabineEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationTenofoviremtricitabineHIV-1pre-exposure prophylaxistenofovir disoproxil fumarate

Identifiers

PMID38484128
PMCPMC7616831
OpenAlexW4392785398

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.