Evidence map›Paper›PMID 34240467›Full record

ArticleBritish journal of clinical pharmacology2022

Multicompartmental pharmacokinetic evaluation of long-acting cabotegravir in healthy adults for HIV preexposure prophylaxis.

Jafar Sadik Shaik, Ethel D Weld, Stacey Edick, Edward Fuchs, Sharon Riddler, Mark A Marzinke, Ronald D'Amico, Kalpana Bakshi, Yu Lou, Craig Hendrix and 5 more

Open access · greenAbstract readClinical Trial, Phase I
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 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.0field-weighted citation impact, top 21% 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

16 citing papers in PubMed, 23 citations in OpenAlex.

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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

15 authors at 7 institutions in 1 country.

Jafar Sadik ShaikGlaxoSmithKline, Collegeville, PA, USA.
Ethel D WeldJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Stacey EdickUniversity of Pittsburgh, Pittsburgh, PA, USA.
Edward FuchsJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Sharon RiddlerUniversity of Pittsburgh, Pittsburgh, PA, USA.
Mark A MarzinkeJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Ronald D'AmicoViiV Healthcare, Research Triangle Park, NC, USA.
Kalpana BakshiGlaxoSmithKline, Collegeville, PA, USA.
Yu LouPrecision Biosciences, Durham, NC, USA.
Craig HendrixJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Kelong HanGlaxoSmithKline, Collegeville, PA, USA.
Susan L FordGlaxoSmithKline, Research Triangle Park, NC, USA.
David MargolisViiV Healthcare, Research Triangle Park, NC, USA.
William SpreenViiV Healthcare, Research Triangle Park, NC, USA.
Parul PatelViiV Healthcare, Research Triangle Park, NC, USA.
Research Triangle Park Foundation · USGlaxoSmithKline (United States) · USJohns Hopkins Medicine · USJohns Hopkins University · USUniversity of Pittsburgh · USPrecision BioSciences (United States) · USTriangle · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsCabotegravir is an integrase strand transfer inhibitor in clinical development as long-acting (LA) injectable HIV preexposure prophylaxis.

methodsThis phase I study assessed pharmacokinetics of cabotegravir in plasma and anatomical sites associated with sexual HIV-1 transmission after repeated oral and single intramuscular (IM) LA dosing in healthy adults. Following a 28-day oral lead-in period of cabotegravir 30 mg and a washout period of 14-42 days, participants were administered a single ultrasound-guided gluteal IM cabotegravir LA 600-mg injection. The study objective was to characterize cabotegravir concentrations in plasma, cervical, vaginal and rectal tissues, and cervicovaginal and rectal fluids and up to Week 12 after IM injection.

resultsNineteen participants enrolled and 16 completed the study through Week 52. Cabotegravir was detected in plasma and all tissues and fluids. Median plasma cabotegravir concentrations exceeded the in vitro protein-adjusted 90% maximal inhibitory concentration through Week 12. Median tissue- and fluid-to-plasma cabotegravir concentration ratios across all visits were 0.32 for rectal fluid and 0.08-0.16 for other tissues and fluids. Adjusted R

conclusionConcentrations of cabotegravir in tissues and fluids were proportional to plasma over time, with strong correlations between tissue and plasma concentrations. Cabotegravir LA tissue-to-plasma ratios may be important for understanding its use as preexposure prophylaxis.

Indexed as

Anti-HIV AgentsHIV-1HIV InfectionsAdultDiketopiperazinesFemaleHumansInjections, IntramuscularPyridonesAnti-HIV AgentscabotegravirDiketopiperazinesPyridonesantiretroviralsHIV/AIDSpharmacokinetic-pharmacodynamic

Identifiers

PMID34240467
PMCPMC9290068
OpenAlexW3177529243

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.