Individualized Adherence Benchmarks for HIV Pre-Exposure Prophylaxis.


Journal

AIDS research and human retroviruses
ISSN: 1931-8405
Titre abrégé: AIDS Res Hum Retroviruses
Pays: United States
ID NLM: 8709376

Informations de publication

Date de publication:
06 2021
Historique:
pubmed: 17 11 2020
medline: 19 8 2021
entrez: 16 11 2020
Statut: ppublish

Résumé

Tenofovir diphosphate (TFV-DP) concentrations measured with dried blood spots (DBS) can be used to classify adherence to emtricitabine/tenofovir disoproxil fumarate (F/TDF) for HIV pre-exposure prophylaxis (PrEP). A TFV-DP of 700 fmol/punch was previously associated with high PrEP efficacy, and was estimated to represent ≥4 doses/week on average. However, interindividual variability in TFV-DP concentrations may lead to adherence misclassification and decrease the precision of adherence-efficacy relationships. The purpose of this analysis was to evaluate sources of TFV-DP variability to improve the precision of TFV-DP for adherence assessments by incorporating individual characteristics. Data and samples from a 36-week study of TFV-DP in DBS, collected biweekly, among 48 HIV-negative volunteers (25 Females/26 Caucasian/10 African American/14 Hispanic) receiving F/TDF at 33%, 67%, and 100% of daily dosing under directly observed therapy were used for analysis. The simplest pharmacokinetic model to describe TFV-DP accumulation with acceptable performance was a one-compartment constant input model. Covariates, including laboratory values and demographics were ranked in importance of their association with

Identifiants

pubmed: 33191774
doi: 10.1089/AID.2020.0108
pmc: PMC8213008
doi:

Substances chimiques

Anti-HIV Agents 0
Emtricitabine G70B4ETF4S

Banques de données

ClinicalTrials.gov
['NCT02022657']

Types de publication

Clinical Trial Journal Article Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

421-428

Subventions

Organisme : NIAID NIH HHS
ID : R01 AI122298
Pays : United States
Organisme : NIAID NIH HHS
ID : K23 AI104315
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001082
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI106499
Pays : United States

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Auteurs

Mustafa E Ibrahim (ME)

Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.

Jose R Castillo-Mancilla (JR)

Department of Medicine, Division of Infectious Diseases, School of Medicine, University of Colorado, Aurora, Colorado, USA.

Jenna Yager (J)

Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.

Kristina M Brooks (KM)

Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.

Lane Bushman (L)

Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.

Laura Saba (L)

Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.

Jennifer J Kiser (JJ)

Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.

Samantha MaWhinney (S)

Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado, Aurora, Colorado, USA.

Peter L Anderson (PL)

Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.

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