Evidence map›Paper›PMID 30212404›Full record

ArticleAIDS (London, England)2018

Similar tenofovir hair concentrations in men and women after directly observed dosing of tenofovir disoproxil fumarate/emtricitabine: implications for preexposure prophylaxis adherence monitoring.

Catherine A Koss, Albert Y Liu, Jose Castillo-Mancilla, Peter Bacchetti, Cricket McHugh, Karen Kuncze, Mary Morrow, Alexander Louie, Sharon Seifert, Hideaki Okochi and 3 more

Registry-linked trialAbstract readComparative Study
In one paragraph

Article in AIDS (London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02022657 (PrEP Adherence Monitoring Using Dried Blood Spots), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.6field-weighted citation impact, top 17% 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.

NCT02022657 phase1 / phase2completednot on this map

PrEP Adherence Monitoring Using Dried Blood Spots

TypeinterventionalSponsorUniversity of Colorado, DenverRan2014 to 2017Enrolled52ConditionsPrEP Adherence MonitoringArmsTruvada
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. 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

13 authors at 4 institutions in 1 country.

Catherine A KossDivision of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California, San Francisco, California.
Albert Y LiuBridge HIV, San Francisco Department of Public Health, California.
Jose Castillo-MancillaDivision of Infectious Diseases, Department of Medicine, University of Colorado Anschutz Medical Campus, Colorado.
Peter BacchettiDepartment of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.
Cricket McHughSkaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus.
Karen KunczeDivision of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California, San Francisco, California.
Mary MorrowDepartment of Biostatistics and Informatics, University of Colorado, Colorado School of Public Health, Colorado.
Alexander LouieDivision of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California, San Francisco, California.
Sharon SeifertSkaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus.
Hideaki OkochiDepartment of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California, San Francisco, California, USA.
Samantha MaWhinneyDepartment of Biostatistics and Informatics, University of Colorado, Colorado School of Public Health, Colorado.
Monica GandhiDivision of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California, San Francisco, California.
Peter L AndersonSkaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus.
University of California, San Francisco · USUniversity of Colorado Anschutz Medical Campus · USColorado School of Public Health · USSan Francisco Department of Public Health · US

Funding

Virology CoreP30AI027763 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI STEVEN Grant DEEKS · 1988 to 2026
$93.6M
Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
UCSF/Kaiser-DOR Program for Developing Independent Women's Health ResearchersK12HD052163 · NICHD · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ADLER, NANCY E, BRINDIS, CLAIRE D. · 2005 to 2023
$9.3M
Training in HIV Translational ResearchT32AI060530 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Diane V Havlir · 2005 to 2026
$6.4M
Plugging Hair ARV Levels as Adherence Biomarkers into HIV Prevention TrialsR01AI098472 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GANDHI, MONICA · 2012 to 2021
$5.6M
“Hair Lengthening”: Using Hair Levels to Interpret Long-Acting PrEP Studies.R37AI098472 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Monica Gandhi · 2023 to 2026
$3.2M
PrEP and ART adherence monitoring using dried blood spotsU01AI106499 · NIAID · UNIVERSITY OF COLORADO DENVER · PI ANDERSON, PETER L. · 2013 to 2016
$2.9M
UNIVERSITY OF COLORADO HIV RESEARCH TRAINING PROGRAMT32AI007447 · NIAID · UNIVERSITY OF COLORADO DENVER · PI CAMPBELL, THOMAS B. · 1992 to 2016
$2.8M
Quantifying Drug Adherence and Drug Exposure to Antiretroviral TherapyK23AI104315 · NIAID · UNIVERSITY OF COLORADO DENVER · PI CASTILLO-MANCILLA, JOSE RAMON · 2013 to 2017
$910k
Optimizing Adherence to PrEP among Young African Women through a Community Adherence Club InterventionK23MH114760 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KOSS, CATHERINE ANNE STIMETS · 2018 to 2021
$796k
NCATS NIH HHS UL1 TR001082NIAID NIH HHS K23 AI104315NIAID NIH HHS P30 AI027763NIAID NIH HHS R01 AI098472NIAID NIH HHS R37 AI098472NIAID NIH HHS T32 AI007447NIAID NIH HHS T32 AI060530NIAID NIH HHS U01 AI106499NICHD NIH HHS K12 HD052163NIMH NIH HHS K23 MH114760
6 · The paper itself

Abstract

objectivesWomen likely require higher adherence than men to preexposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) for similar efficacy. Pharmacologic metrics of adherence predict efficacy better than self-report, but expected drug levels (adherence benchmarks) must be established using directly observed therapy. We sought to evaluate whether tenofovir hair concentrations differ between women and men receiving directly observed TDF/FTC.

methodsWe assessed tenofovir hair concentrations in HIV-uninfected volunteers randomized to receive 100%, 67%, or 33% of daily dosing of TDF/FTC for 12 weeks (DOT-DBS, NCT02022657). Hair samples were collected at dosing weeks 4, 8, and 12 and every 3 weeks during a 12-week washout. Tenofovir concentrations in the proximal 1.5 cm of hair (representing ∼6 weeks of exposure) were analyzed using liquid chromatography/tandem mass spectrometry. Linear regression was used to model tenofovir hair concentrations in terms of sex, doses over the prior 6 weeks, and number of days since last dose.

resultsA total of 264 hair samples were analyzed from 23 female and 24 male participants. Female participants had similar tenofovir hair concentrations to men (estimated fold-difference 0.92, 95% CI 0.75-1.13, P = 0.43). The estimated fold-difference in tenofovir levels for female versus male participants did not appreciably change when age (0.93, 95% CI 0.76-1.15), weight (0.89, 95% CI 0.71-1.11), or race/ethnicity (0.95, 95% CI 0.77-1.17) were added to the model.

conclusionWomen and men have similar adherence benchmarks for tenofovir in hair samples. As pharmacokinetic metrics are increasingly used for PrEP monitoring, these findings provide guidance for assessing adherence via hair concentrations.

Indexed as

AdultAnti-HIV AgentsChemopreventionChromatography, LiquidDisease Transmission, InfectiousEmtricitabineFemaleHairHealthy VolunteersHIV InfectionsHumansMaleMiddle AgedPre-Exposure ProphylaxisSex FactorsTandem Mass SpectrometryAnti-HIV AgentsEmtricitabineTenofovir

Identifiers

PMID30212404
PMCPMC6330141
OpenAlexW2884046077

What OpenQuestion holds

Textmetadata
LicenceTDM
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.