Comparing the Novel Method of Assessing PrEP Adherence/exposure Using Hair Samples to Other Pharmacologic and Traditional Measures

Overview

Journal J Acquir Immune Defic Syndr

Specialty Infectious Diseases

Date 2014 Oct 9

PMID 25296098

Citations 58

Authors

Sanjiv M Baxi

Albert Liu

Peter Bacchetti

Gaudensia Mutua

Eduard J Sanders

Freddie M Kibengo

Jessica E Haberer

James Rooney

Craig W Hendrix

Peter L Anderson

Yong Huang

Frances Priddy

Monica Gandhi

Affiliations

Soon will be listed here.

Abstract

Objective: The efficacy of pre-exposure prophylaxis (PrEP) in HIV will diminish with poor adherence; pharmacologic measures of drug exposure have proven critical to PrEP trial interpretation. We assessed drug exposure in hair against other pharmacologic and more routinely used measures to assess pill-taking.

Design: Participants were randomized to placebo, daily PrEP, or intermittent PrEP to evaluate safety and tolerability of daily versus intermittent tenofovir/emtricitabine (TFV/FTC) in 2 phase II PrEP clinical trials conducted in Africa. Different measures of drug exposure, including self-report, medication event monitoring system (MEMS)-caps openings, and TFV/FTC levels in hair and other biomatrices were compared.

Methods: At weeks 8 and 16, self-reported pill-taking, MEMS-caps openings, and TFV/FTC levels in hair, plasma, and peripheral blood mononuclear cells (PBMCs) were measured. Regression models evaluated predictors of TFV/FTC concentrations in the 3 biomatrices; correlation coefficients between pharmacologic and nonpharmacologic measures were calculated. Both trials were registered on ClinicalTrials.gov (NCT00931346/NCT00971230).

Results: Hair collection was highly feasible and acceptable (100% in week 8; 96% in week 16). In multivariate analysis, strong associations were seen between pharmacologic measures and MEMS-caps openings (all P < 0.001); self-report was only weakly associated with pharmacologic measures. TFV/FTC hair concentrations were significantly correlated with levels in plasma and PBMCs (correlation coefficients, 0.41-0.86, all P < 0.001).

Conclusions: Measuring TFV/FTC exposure in small hair samples in African PrEP trials was feasible and acceptable. Hair levels correlated strongly with PBMC, plasma concentrations, and MEMS-caps openings. As in other PrEP trials, self-report was the weakest measure of exposure. Further study of hair TFV/FTC levels in PrEP trials and demonstration projects to assess adherence/exposure is warranted.

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Albrechta H, Goodman G, Oginni E, Mohamed Y, Venkatasubramanian K, Dumas A PLOS Digit Health. 2024; 3(2):e0000457.

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