Evidence map›Paper›PMID 33536904›Full record

ArticleFrontiers in pharmacology2020

Multispecies Evaluation of a Long-Acting Tenofovir Alafenamide Subdermal Implant for HIV Prophylaxis.

Manjula Gunawardana, Mariana Remedios-Chan, Debbie Sanchez, Simon Webster, Patricia Galvan, Rob Fanter, Amalia E Castonguay, Paul Webster, John A Moss, Joseph Kuo and 7 more

Open access · goldAbstract read
In one paragraph

Article in Frontiers in pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.1field-weighted citation impact, top 12% 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

15 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
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  9. Long-Acting Treatments for Hepatitis B.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Article
  10. Review
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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

17 authors at 4 institutions in 1 country.

Manjula GunawardanaDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, CA, United States.
Mariana Remedios-ChanDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, CA, United States.
Debbie SanchezDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, CA, United States.
Simon WebsterDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, CA, United States.
Patricia GalvanDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, CA, United States.
Rob FanterDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, CA, United States.
Amalia E CastonguayDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, CA, United States.
Paul WebsterDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, CA, United States.
John A MossDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, CA, United States.
Joseph KuoDepartment of Immunology and Microbiology, The Scripps Research Institute, La Jolla, CA, United States.
Philippe A GallayDepartment of Immunology and Microbiology, The Scripps Research Institute, La Jolla, CA, United States.
Kathleen L VincentCenter for Biomedical Engineering, University of Texas Medical Branch at Galveston, Galveston, TX, United States.
Massoud MotamediCenter for Biomedical Engineering, University of Texas Medical Branch at Galveston, Galveston, TX, United States.
Dana WeinbergerApprova Consulting LLC, Boulder, CO, United States.
Mark A MarzinkeDepartment of Medicine, Johns Hopkins University, Baltimore, MD, United States.
Craig W HendrixDepartment of Medicine, Johns Hopkins University, Baltimore, MD, United States.
Marc M BaumDepartment of Chemistry, Oak Crest Institute of Science, Monrovia, CA, United States.
Oak Crest Institute of Science · USJohns Hopkins University · USScripps Research Institute · USThe University of Texas Medical Branch at Galveston · US

Funding

Vaccine Response and Immunotherapeutics SWGP30AI094189 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Richard E. Chaisson · 2012 to 2026
$67.0M
Systemic Sustained Release Delivery of Antiretroviral Agents for HIV PreventionR01AI162151 · NIAID · OAK CREST INSTITUTE OF SCIENCE · PI BAUM, MARC MICHAEL · 2021 to 2025
$4.3M
Systemic Sustained Release Delivery of Antiretroviral Agents for HIV PreventionR01AI120748 · NIAID · OAK CREST INSTITUTE OF SCIENCE · PI BAUM, MARC MICHAEL · 2015 to 2019
$4.2M
NIAID NIH HHS P30 AI094189NIAID NIH HHS R01 AI120748NIAID NIH HHS R01 AI162151
6 · The paper itself

Abstract

New HIV-1 infection rates far outpace the targets set by global health organizations, despite important progress in curbing the progression of the epidemic. Long-acting (LA) formulations delivering antiretroviral (ARV) agents for HIV-1 pre-exposure prophylaxis (PrEP) hold significant promise, potentially facilitating adherence due to reduced dosing frequency compared to oral regimens. We have developed a subdermal implant delivering the potent ARV drug tenofovir alafenamide that could provide protection from HIV-1 infection for 6 months, or longer. Implants from the same lot were investigated in mice and sheep for local safety and pharmacokinetics (PKs). Ours is the first report using these animal models to evaluate subdermal implants for HIV-1 PrEP. The devices appeared safe, and the plasma PKs as well as the drug and metabolite concentrations in dermal tissue adjacent to the implants were studied and contrasted in two models spanning the extremes of the body weight spectrum. Drug and drug metabolite concentrations in dermal tissue are key in assessing local exposure and any toxicity related to the active agent. Based on our analysis, both animal models were shown to hold significant promise in LA product development.

Indexed as

HIV preventionlong-actingpre-exposure prophylaxissubdermal implantsustained releasetenofovir alafenamide

Identifiers

PMID33536904
PMCPMC7849190
OpenAlexW3108345840

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.