Evidence map›Paper›PMID 35949044›Full record

ArticleBritish journal of clinical pharmacology2022

A population pharmacokinetic model based on HPTN 077 of long-acting injectable cabotegravir for HIV PrEP.

Yifan Yu, Kristin L Bigos, Mark A Marzinke, Raphael J Landovitz, Marybeth McCauley, Susan Ford, Craig W Hendrix, Robert R Bies, Ethel D Weld, HPTN 077 Study Team

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.8field-weighted citation impact, top 27% 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

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Observational
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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

10 authors at 5 institutions in 2 countries.

Yifan YuSchool of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo, Buffalo, NY, USA.
Kristin L BigosDepartment of Medicine, Division of Clinical Pharmacology, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Mark A MarzinkeDepartment of Medicine, Division of Clinical Pharmacology, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID 0000-0003-1670-8786
Raphael J LandovitzLos Angeles, Center for Clinical AIDS Research and Education, The University of California, Los Angeles, CA, USA.
Marybeth McCauleyFHI 360, Durham, NC, USA.
Susan FordGlaxoSmithKline, Research Triangle Park, NC, USA.
Craig W HendrixDepartment of Medicine, Division of Clinical Pharmacology, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Robert R BiesSchool of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo, Buffalo, NY, USA.
Ethel D WeldDepartment of Medicine, Division of Clinical Pharmacology, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID 0000-0002-9519-3348
HPTN 077 Study Team
Johns Hopkins University · USUniversity at Buffalo, State University of New York · USAPLA Health · USFamily Health International 360 · USResearch Triangle Park Foundation · US

Funding

LC: HIV Prevention Trials Network - Laboratory Support for the SARS-CoV-2 Seroprevalence Study (CoVPN 5002)UM1AI068613 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SUSAN H ESHLEMAN, Mark A Marzinke · 2011 to 2026
$100.2M
Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
The Indiana University-Ohio State University Maternal and Pediatric Precision in Therapeutics Data, Model, Knowledge, and Research Coordination Center (IU-OSU MPRINT DMKRCC)P30HD106451 · NICHD · INDIANA UNIVERSITY INDIANAPOLIS · PI Lang Li, Sara K Quinney · 2021 to 2026
$24.1M
Optimizing the Use of Long-Acting Antiretrovirals for Youth Living withHIVK23AI165290 · NIAID · JOHNS HOPKINS UNIVERSITY · PI WELD, ETHEL DERBY · 2021 to 2024
$702k
NIAID NIH HHS K23 AI165290NIAID NIH HHS P30 AI094189NIAID NIH HHS UM1 AI068613NICHD NIH HHS P30 HD106451
6 · The paper itself

Abstract

aimsCabotegravir delivered as a long-acting intramuscular injection has shown superior efficacy to oral tenofovir-emtricitabine as pre-exposure prophylaxis (PrEP) for HIV. Cabotegravir pharmacokinetics (PK), like those of other long-acting depot preparations, exhibit variability between individuals and between injection occasions. The aim of this study is to describe the population pharmacokinetics of long-acting cabotegravir (CAB-LA).

methodsUsing available PK measurements from 133 participants in the HIV Prevention Trials Network (HPTN) 077 trial, we analysed CAB-LA PK data using nonlinear mixed-effects modelling to develop a population PK model.

resultsA two-compartment model with first order absorption best described the CAB-LA PK. The analysis identified between-occasion variability (BOV, i.e., differences in PK within one individual from one injection to the next) as a significant covariate affecting the absorption rate, with an estimated contribution of BOV to PK variability on the absorption rate (k

conclusionThe public availability of this model will facilitate and enable a wide variety of future clinically relevant simulations to inform the optimal use of CAB-LA.

Indexed as

Anti-HIV AgentsHIV InfectionsBody WeightDiketopiperazinesFemaleHumansInjections, IntramuscularMalePyridonesAnti-HIV AgentscabotegravirDiketopiperazinesPyridonesantiretroviralsHIV/AIDSinfectious diseasespharmacometrics

Identifiers

PMID35949044
PMCPMC10077525
OpenAlexW4291019872

What OpenQuestion holds

Textmetadata
LicenceTDM
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.