Evidence map›Paper›PMID 26975357›Full record

ArticlePharmaceutical research2016

A Tunable, Biodegradable, Thin-Film Polymer Device as a Long-Acting Implant Delivering Tenofovir Alafenamide Fumarate for HIV Pre-exposure Prophylaxis.

Erica Schlesinger, Daniel Johengen, Ellen Luecke, Ginger Rothrock, Ian McGowan, Ariane van der Straten, Tejal Desai

Open access · greenAbstract read
In one paragraph

Article in Pharmaceutical research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed
8.5field-weighted citation impact, top 2% 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

58 citing papers in PubMed, 97 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Long-Acting Treatments for Hepatitis B.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. HIV prevention: better choice for better coverage.Journal of the International AIDS Society · 2022
    Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review
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

7 authors at 3 institutions in 1 country.

Erica SchlesingerUC Berkeley-UCSF Graduate Program in Bioengineering, 1700 4th Street Room 204, UCSF Mission Bay Campus,, San Francisco, California, 94158, USA.
Daniel JohengenDepartment of Bioengineering and Therapeutic Sciences, 1700 4th Street Room 204, UCSF Mission Bay Campus,, San Francisco, California, 94158, USA.
Ellen LueckeWomen's Global Health Imperative, RTI International, 351 California Street,, San Francisco, California, 94104, USA.
Ginger RothrockEmerging Technologies, Research Triangle Institute (RTI) International, Research Triangle Park, North Carolina, 27709, USA.
Ian McGowanUniversity of Pittsburgh Medical School, 204 Craft Ave Rm B-621, Pittsburgh, Pennsylvania, 15213, USA.
Ariane van der StratenWomen's Global Health Imperative, RTI International, 351 California Street,, San Francisco, California, 94104, USA.
Tejal DesaiUC Berkeley-UCSF Graduate Program in Bioengineering, 1700 4th Street Room 204, UCSF Mission Bay Campus,, San Francisco, California, 94158, USA. tejal.desai@ucsf.edu.
RTI International · USGraduate Theological Union · USUniversity of Pittsburgh · US

Funding

Ujima Mentoring ProgramP30MH062246 · NIMH · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MALLORY O JOHNSON · 2001 to 2026
$57.4M
UCSF/UCB Joint Graduate Group in BIoengineeringT32GM008155 · NIGMS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DESAI, TEJAL A. · 1985 to 2020
$12.2M
Nanoporous Films for Ocular Drug DeliveryR01EY021574 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DESAI, TEJAL A. · 2011 to 2014
$1.5M
NEI NIH HHS R01 EY021574NIGMS NIH HHS T32 GM008155NIMH NIH HHS P30 MH062246
6 · The paper itself

Abstract

purposeThe effectiveness of Tenofovir based HIV pre-exposure prophylaxis (PrEP) is proven, but hinges on correct and consistent use. User compliance and therapeutic effectiveness can be improved by long acting drug delivery systems. Here we describe a thin-film polymer device (TFPD) as a biodegradable subcutaneous implant for PrEP.

methodsA thin-film polycaprolactone (PCL) membrane controls drug release from a reservoir. To achieve membrane controlled release, TAF requires a formulation excipient such as PEG300 to increase the dissolution rate and reservoir solubility. Short-term In vitro release studies are used to develop an empirical design model, which is applied to the production of in vitro prototype devices demonstrating up to 90-days of linear release and TAF chemical stability.

resultsThe size and shape of the TFPD are tunable, achieving release rates ranging from 0.5 to 4.4 mg/day in devices no larger than a contraceptive implant. Based on published data for oral TAF, subcutaneous constant-rate release for HIV PrEP is estimated at <2.8 mg/day. Prototype devices demonstrated linear release at 1.2 mg/day for up to 90 days and at 2.2 mg/day for up to 60 days.

conclusionsWe present a biodegradable TFPD for subcutaneous delivery of TAF for HIV PrEP. The size, shape and release rate of the device are tunable over a >8-fold range.

Indexed as

AdenineAlanineAnti-HIV AgentsBiodegradable PlasticsChemistry, PharmaceuticalDelayed-Action PreparationsDrug Delivery SystemsDrug LiberationFumaratesHIV-1Particle SizePolyestersPolymersPre-Exposure ProphylaxisSolubilityTenofovirAdenineAlanineAnti-HIV AgentsBiodegradable PlasticsDelayed-Action PreparationsFumaratespolycaprolactonePolyestersPolymersTenofovirtenofovir alafenamideantiretroviralbiodegradable implantHIV pre-exposure prophylaxismembrane controlled releasepolycaprolactonetenofovir alafenamide fumarate

Identifiers

PMID26975357
PMCPMC4892981
OpenAlexW2300282509

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.