Evidence map›Paper›PMID 27572401›Full record

SynthesisAntimicrobial agents and chemotherapy2016

Emtricitabine-Triphosphate in Dried Blood Spots as a Marker of Recent Dosing.

Jose Castillo-Mancilla, Sharon Seifert, Kayla Campbell, Stacey Coleman, Kevin McAllister, Jia-Hua Zheng, Edward M Gardner, Albert Liu, David V Glidden, Robert Grant and 5 more

7 registry-linked trialsOpen access · bronzeAbstract readMeta-Analysis
In one paragraph

Synthesis in Antimicrobial agents and chemotherapy, 2016. 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 49 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 2 pooled it
5.1field-weighted citation impact, top 4% 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
NCT01040091 phase1completednot on this map

Cellular Pharmacology of Tenofovir and Emtricitabine for HIV Prophylaxis (Cell Prep)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2009 to 2014Enrolled34ConditionsHIV InfectionsArmsEmtricitabine (FTC), Tenofovir disoproxil fumarate (TDF), Efavirenz (EFV), Truvada
NCT01772823 phase2completednot on this map

Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among Young Men Who Have Sex With Men (YMSM) in the United States

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2012 to 2015Enrolled200ConditionsHIV InfectionArms3MV, PCC, Emtricitabine/tenofovir (FTC/TDF (Truvada®))
NCT02012621 completednot on this map

Quantifying Drug Adherence and Drug Exposure to Antiretroviral Therapy.

TypeobservationalSponsorUniversity of Colorado, DenverRan2013 to 2017Enrolled807ConditionsHIV/AIDS
NCT02022657 phase1 / phase2completednot on this map

PrEP Adherence Monitoring Using Dried Blood Spots

TypeinterventionalSponsorUniversity of Colorado, DenverRan2014 to 2017Enrolled52ConditionsPrEP Adherence MonitoringArmsTruvada
NCT04530630 phase4completednot on this mapstarted 2020, after this paper: background citation

The Efficacy, Safety, and Tolerability of Switching to a Bictegravir (BIC)/Emtricitabine(FTC)/Tenofovir Alafenamide (TAF) Regimen in Virally Suppressed Human Immunodeficiency Viruses (HIV)-Positive Patients Post-Renal Transplant

TypeinterventionalSponsorWeill Medical College of Cornell UniversityRan2020 to 2024Enrolled20ConditionsHIV Infections, Renal Transplant RejectionArmsBIC/F/TAF 50Mg-200Mg-25Mg Tablet
NCT05044013 nacompletednot on this mapstarted 2023, after this paper: background citation

Training in mHealth Prevention With MSM

TypeinterventionalSponsorUniversity of ConnecticutRan2023 to 2025Enrolled90ConditionsHIV Prevention ProgramArmsFull access to JomPrEP app, inactivated JomPrEP app
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Review
  9. Article
  10. Article
  11. A Cross-Biomeasure Study to Optimize Antiretroviral Adherence Estimation.Journal of acquired immune deficiency syndromes (1999) · 2025
    Article
  12. Observational
  13. Adherence measurement considerations for oral antiretroviral medications.Journal of the International AIDS Society · 2024
    Article
  14. Article
  15. Article
  16. Article
  17. Observational
  18. Article
  19. Article
  20. 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

15 authors at 7 institutions in 1 country.

Jose Castillo-MancillaDivision of Infectious Diseases, School of Medicine, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.
Sharon SeifertDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.
Kayla CampbellDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.
Stacey ColemanDivision of Infectious Diseases, School of Medicine, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.
Kevin McAllisterDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.
Jia-Hua ZhengDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.
Edward M GardnerDivision of Infectious Diseases, School of Medicine, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.
Albert LiuBridge HIV, San Francisco Department of Public Health, San Francisco, California, USA.
David V GliddenDepartment of Epidemiology and Biostatistics, University of California, San Francisco, California, USA.
Robert GrantGladstone Institute, University of California, San Francisco, California, USA.
Sybil HosekDepartment of Psychiatry, John H. Stroger Jr. Hospital of Cook County, Chicago, Illinois, USA.
Craig M WilsonDepartment of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Lane R BushmanDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.
Samantha MaWhinneyDepartment of Biostatistics and Bioinformatics, Colorado School of Public Health, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA.
Peter L AndersonDepartment of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado-Anschutz Medical Campus, Aurora, Colorado, USA peter.anderson@ucdenver.edu.
University of Colorado Anschutz Medical Campus · USGladstone Institutes · USJohn H. Stroger, Jr. Hospital of Cook County · USSan Francisco Department of Public Health · USUniversity of Alabama at Birmingham · USUniversity of California, San Francisco · USUniversity of Montana · US

Funding

LEADERSHIP GROUP FOR ADOLESCENT MEDICINE TRIALS NETWORKU01HD040533 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WILSON, CRAIG M · 2001 to 2016
$76.4M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
Cellular pharmacology of tenofovir and emtricitabine for HIV prophylaxisU01AI084735 · NIAID · UNIVERSITY OF COLORADO DENVER · PI ANDERSON, PETER L. · 2009 to 2012
$4.2M
Chemoprophylaxis and HIV Host InteractionsR01AI118575 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANT, ROBERT M. · 2015 to 2019
$2.9M
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
NCATS NIH HHS UL1 TR001082NIAID NIH HHS K23 AI104315NIAID NIH HHS R01 AI118575NIAID NIH HHS T32 AI007447NIAID NIH HHS U01 AI084735NIAID NIH HHS U01 AI106499NICHD NIH HHS U01 HD040533
6 · The paper itself

Abstract

New objective measures of antiretroviral adherence are needed. We determined if emtricitabine triphosphate (FTC-TP) in dried blood spots (DBS) can be used as a marker of recent dosing with tenofovir disoproxil fumarate-emtricitabine (TDF-FTC). The half-life of FTC-TP was estimated in DBS samples obtained from an intensive pharmacokinetic (PK) study of coformulated TDF-FTC in HIV-negative and HIV-infected participants. The concordance of quantifiable FTC-TP in DBS with tenofovir (TFV)/FTC in plasma was evaluated by utilizing paired plasma-DBS samples from participants enrolled in 2 large preexposure prophylaxis (PrEP) open-label trials. The time to FTC-TP nondetectability after TDF-FTC dosing was evaluated utilizing DBS from HIV-negative participants enrolled in a directly observed therapy study of variable adherence to TDF-FTC. The mean (95% confidence interval [CI]) terminal half-life of FTC-TP in the PK study was 35 (23 to 47) h. A total of 143/163 (88%) samples obtained 0 to 48 h post-TDF-FTC dose had quantifiable FTC-TP in DBS, compared with 2/93 (2%) and 0/87 (0%) obtained >48 and >96 h postdose. In 746 paired plasma-DBS samples from 445 participants enrolled in PrEP trials, when both TFV/FTC in plasma were below the limit of quantification, FTC-TP was as well in 98.9% of the samples, and when either TFV or FTC in plasma was quantifiable, FTC-TP was as well in 90.5% of the samples. The half-life of FTC-TP in DBS is short relative to that of TFV-diphosphate (TFV-DP), making it a surrogate for TFV-FTC detection in plasma. FTC-TP can be quantified in DBS simultaneously with TFV-DP, which quantifies cumulative adherence to TDF-FTC. (The clinical trials discussed in this article have been registered at ClinicalTrials.gov under identifiers NCT01040091, NCT02022657, NCT00458393, NCT01772823, and NCT02012621.).

Indexed as

Anti-HIV AgentsDried Blood Spot TestingDrug MonitoringEmtricitabineHIV InfectionsTenofovirAdolescentAdultAgedCase-Control StudiesClinical Studies as TopicDrug Administration ScheduleFemaleHalf-LifeHIVHumansAnti-HIV AgentsEmtricitabineTenofovir

Identifiers

PMID27572401
PMCPMC5075074
OpenAlexW2514546776

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

and 1 more above

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.