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Individualized Adherence Benchmarks for HIV Pre-Exposure Prophylaxis.

Mustafa E Ibrahim1, Jose R Castillo-Mancilla2, Jenna Yager1

  • 1Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.

AIDS Research and Human Retroviruses
|November 16, 2020
PubMed
Summary

Dried blood spot tenofovir diphosphate (TFV-DP) levels accurately assess adherence to HIV pre-exposure prophylaxis (PrEP). Individualizing TFV-DP benchmarks using weight and platelet count improves adherence classification and supports flexible PrEP dosing.

Keywords:
HIVadherencepharmacokineticspre-exposure prophylaxis

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Area of Science:

  • Pharmacokinetics and Pharmacodynamics
  • HIV Prevention Research
  • Biomarker Analysis

Background:

  • Dried blood spot (DBS) tenofovir diphosphate (TFV-DP) concentrations are used to monitor adherence to emtricitabine/tenofovir disoproxil fumarate (F/TDF) for HIV pre-exposure prophylaxis (PrEP).
  • A previous threshold of 700 fmol/punch for TFV-DP was associated with high PrEP efficacy, presumed to represent ≥4 doses/week.
  • Interindividual variability in TFV-DP concentrations can lead to adherence misclassification and reduced precision in adherence-efficacy relationships.

Purpose of the Study:

  • To evaluate sources of TFV-DP variability to enhance the precision of adherence assessments.
  • To incorporate individual characteristics into TFV-DP analysis for improved adherence classification.
  • To refine benchmarks for TFV-DP concentrations based on individual factors.

Main Methods:

  • Analysis of TFV-DP in DBS collected biweekly over 36 weeks from 48 HIV-negative volunteers on F/TDF.
  • Application of a one-compartment constant input pharmacokinetic model to describe TFV-DP accumulation.
  • Random forest analysis to identify key covariates (weight, platelet count) influencing pharmacokinetic parameters, followed by simulations to generate new adherence benchmarks.

Main Results:

  • Body weight and platelet count were identified as significant covariates influencing TFV-DP concentrations.
  • Simulations generated new benchmarks for adherence levels (<2, 2-3, 4-5, 6-7 doses/week).
  • The protective TFV-DP concentration (≥700 fmol/punch) was achieved with 2-3 doses/week for individuals ≤110 kg and ≥4 doses/week for individuals >110 kg, reducing misclassification rates from 30% to 17%.

Conclusions:

  • Incorporating body weight and platelet count significantly improves the precision of TFV-DP concentrations for adherence assessment.
  • Previous TFV-DP benchmarks for F/TDF adherence were conservative, suggesting greater pharmacological forgiveness.
  • These findings support further investigation into intermittent PrEP dosing regimens.