Evidence map›Paper›PMID 38399255›Full record

ArticlePharmaceutics2024

Pharmacokinetic Modeling to Guide Preclinical Development of an Islatravir-Eluting Reservoir-Style Biodegradable Implant for Long-Acting HIV PrEP.

Talisa S Kinsale, Mackenzie L Cottrell, Linying Li, Rhonda Brand, Greg Gatto, Ellen Luecke, Chasity Norton, Archana Krovi, Julie B Dumond, Gauri Rao and 5 more

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

Article in Pharmaceutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 32% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. 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 4 institutions in 1 country.

Talisa S KinsaleDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC 27599, USA.ORCID 0000-0002-3102-3040
Mackenzie L CottrellDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC 27599, USA.
Linying LiBiomedical Technologies RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC 27709, USA.ORCID 0000-0002-0373-5905
Rhonda BrandMagee-Womens Research Institute, University of Pittsburgh, Pittsburgh, PA 15213, USA.
Greg GattoGlobal Public Health Impact Center, RTI International, Research Triangle Park, NC 27709, USA.
Ellen LueckeGlobal Public Health Impact Center, RTI International, Research Triangle Park, NC 27709, USA.ORCID 0000-0003-1509-5092
Chasity NortonBiomedical Technologies RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC 27709, USA.ORCID 0000-0001-6730-5181
Archana KroviBiomedical Technologies RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC 27709, USA.ORCID 0000-0003-1546-9955
Julie B DumondDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC 27599, USA.
Gauri RaoDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC 27599, USA.
Shekhar YeshwanteDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC 27599, USA.
Brian Van HorneDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC 27599, USA.
Ariane Van Der StratenCenter for AIDS Prevention Studies (CAPS), Department of Medicine, University of California San Francisco, San Francisco, CA 94104, USA.
Angela D M KashubaDivision of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC 27599, USA.
Leah M JohnsonBiomedical Technologies RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC 27709, USA.
University of North Carolina at Chapel Hill · USRTI International · USUniversity of California, San Francisco · USUniversity of Pittsburgh · US

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
NIAID NIH HHS P30 AI050410PEPFAR AID-0AA-A-14-00012PEPFAR AID-OAA-A-17-00011
6 · The paper itself

Abstract

Long-acting injectable cabotegravir is more effective than daily oral PrEP at preventing HIV transmission due to improved adherence, but requires bi-monthly large-volume intramuscular injections. Subcutaneous (SC) contraceptive implants can be formulated with antiretrovirals for extended-duration HIV PrEP. Islatravir (ISL) is a first-in-class, investigational antiretroviral with pharmacologic properties well-suited for implant delivery. We performed preclinical studies for the development of a reservoir-style, poly(ε-caprolactone) ISL-eluting implant by conducting a single-dose SC ISL dose-ranging pharmacokinetic (PK) study of 0.1, 0.3, and 1 mg/kg in adult Wistar rats. Non-compartmental analysis was conducted, and dose proportionality assessed for ISL plasma and intracellular islatravir-triphosphate (ISL-tp). Population PK models estimated ISL's unit impulse response to deconvolve ISL-implant in vivo absorption rate (mg/day) and cumulative mass (mg) from published rat plasma PK (

Indexed as

antiretroviral agentsextended-durationHIV preventionislatravirlong-acting implantpreexposure prophylaxis

Identifiers

PMID38399255
PMCPMC10893066
OpenAlexW4391346557

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.