# Quantifying the Effects of Alcohol Use on Antiviral Adherence

> **NIH NIH F31** · UNIVERSITY OF COLORADO DENVER · 2020 · $32,540

## Abstract

PROJECT SUMMARY
Alcohol consumption is prevalent in persons with Hepatitis C virus (HCV) infection. However, studies relating
alcohol consumption with HCV treatment outcomes, like adherence and efficacy, are limited. This is partly due
to the exclusion of those with heavy alcohol use from clinical trials and in practice. Studies examining the
relationship between alcohol use and treatment outcomes mainly rely on self-reported alcohol measures. Self-
report consistently underrepresents alcohol consumption in this population, thus an objective measure of
alcohol consumption is needed. Phosphatidylethanol (PEth) is an ideal objective measure of alcohol
consumption. PEth is 100% specific for alcohol consumption with an approximately two-week window of
detection and dose proportionality. Through the work proposed, a liquid chromatography tandem mass
spectrometry (LC-MS/MS) method to quantify PEth in dried blood spots (DBS) will be developed and validated.
This method will be used to quantify alcohol consumption in sixty alcohol and drug users with HCV infection
treated with ledipasvir/sofosbuvir (LDV/SOF 400 mg/90 mg, Harvoni®) in the INCLUD trial (NCT 02573376).
The association between PEth concentrations in 360 DBS samples measured throughout HCV treatment and
objective measures of adherence will be established. Objective measures of adherence include directly
observed therapy (DOT) and wirelessly observed therapy (WOT) data, as well as cumulative sofosbuvir
adherence in DBS as quantified by intracellular concentrations of this prodrug’s active form, 007-triphosphate.
This application will test the hypothesis that increased alcohol consumption as defined by PEth
concentrations will result in decreased antiviral adherence. In the course of method development and
validation, the impact of various sample collection, storage, and unique DBS factors on PEth concentrations in
DBS will be evaluated in order to ensure the most accurate quantification of this biomarker. Mixed model
analyses will then be performed using longitudinal data to elucidate the relationship between alcohol use and
antiviral adherence. Expansion of HCV treatment is essential to eliminate this disease. An NIAAA mission is to
develop tools to generate evidence-based information about alcohol and public health in order to facilitate
implementation of treatment interventions. This work will encourage HCV treatment by providing objective data
on the association between alcohol use and HCV treatment adherence. PEth interpretation will be informed
and improved through use of a fully validated DBS-based method. Findings will enhance the use of quantitative
biomarkers for measuring alcohol consumption in the HCV field and beyond.

## Key facts

- **NIH application ID:** 10140628
- **Project number:** 1F31AA028977-01
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** Lana M Salah
- **Activity code:** F31 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $32,540
- **Award type:** 1
- **Project period:** 2020-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10140628

## Citation

> US National Institutes of Health, RePORTER application 10140628, Quantifying the Effects of Alcohol Use on Antiviral Adherence (1F31AA028977-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10140628. Licensed CC0.

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