Evidence map›Paper›PMID 37814498›Full record

ArticleCPT: pharmacometrics & systems pharmacology2023

A multicompartment population PK model to predict tenofovir and emtricitabine mucosal tissue concentrations for HIV prevention.

Erick Leung, Mackenzie L Cottrell, Craig Sykes, Nicole White, Angela D M Kashuba, Julie B Dumond

Open access · goldAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 39% 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

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Review
  3. 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

6 authors at 1 institution in 1 country.

Erick LeungDivision of Pharmacotherapy and Experimental Therapeutics, University of North Carolina UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.ORCID 0000-0002-3753-1900
Mackenzie L CottrellDivision of Pharmacotherapy and Experimental Therapeutics, University of North Carolina UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.ORCID 0000-0002-0291-5111
Craig SykesDivision of Pharmacotherapy and Experimental Therapeutics, University of North Carolina UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.
Nicole WhiteUniversity of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Angela D M KashubaDivision of Pharmacotherapy and Experimental Therapeutics, University of North Carolina UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.ORCID 0000-0002-9171-8493
Julie B DumondDivision of Pharmacotherapy and Experimental Therapeutics, University of North Carolina UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.ORCID 0000-0002-3500-5819
University of North Carolina at Chapel Hill · US

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program-Evaluation SupplementT32GM086330 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KIM L.R. BROUWER, Daniel Gonzalez · 2011 to 2026
$8.5M
NIAID NIH HHS P30 AI050410NIGMS NIH HHS 5T32GM086330NIGMS NIH HHS T32 GM086330
6 · The paper itself

Abstract

A priori use of mathematical modeling and simulation to predict outcomes from incomplete adherence or reduced frequency dosing strategies may mitigate the risk of clinical trial failure with HIV pre-exposure prophylaxis regimens. We developed a semi-physiologic population pharmacokinetic model for two antiretrovirals and their active intracellular metabolites in three mucosal tissues using pharmacokinetic data from a phase I, dose-ranging study. Healthy female volunteers were given a single oral dose of tenofovir disoproxil fumarate (150, 300, or 600 mg) or emtricitabine (100, 200, or 400 mg). Simultaneous co-modeling of all data was performed on a Linux cluster. A 16 compartment, bolus input, linear kinetic model best described the data, containing 986 observations in 23 individuals across three matrices and four analytes. Combined with a defined efficacious concentration target in mucosal tissues, this model can be used to optimize the dose and dosing frequency through Monte-Carlo simulations.

Indexed as

Anti-HIV AgentsHIV InfectionsPre-Exposure ProphylaxisEmtricitabineFemaleHumansTenofovirAnti-HIV AgentsEmtricitabineTenofovir

Identifiers

PMID37814498
PMCPMC10725258
OpenAlexW4387473045

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.