# Safety and Effectiveness of Medications for Alcohol Use Disorder among HIV+/-

> **NIH NIH P01** · YALE UNIVERSITY · 2023 · $530,763

## Abstract

HARP PROJECT 2 SUMMARY
Although rarely addressed by HIV healthcare providers, alcohol use disorder (AUD) is a major cause of
morbidity and mortality among people aging with HIV (PAH). There are only three Food and Drug
Administration-approved medications for AUD and these have had limited acceptability and uptake for several
reasons. HIV providers are unfamiliar with AUD medications and reticent to add an unfamiliar medication in the
complex context of pre-existing polypharmacy and physiologic frailty. Even in less complex contexts, the
effectiveness of these medications is modest on average, likely due in part to variations in genetic liability.
Further, despite PAH’s excess liability for hepatic injury from alcohol-associated liver disease (AALD), we lack
medications to mitigate this injury. As more people are aging with HIV and they continue to drink alcohol, there
is growing need to identify and evaluate candidate AUD and AALD medications that will be safe and effective
in the context of polypharmacy and physiologic frailty. Analyses of large scale, real-world data may help us
identify and evaluate candidate medications for repurposing (i.e., medications commonly used for other
purposes that may also decrease drinking or hepatic injury). Building on our strong collaborative history and
supported by the larger HIV and Alcohol Research center focused on Polypharmacy (HARP) Program, we will
apply innovative approaches to enhance timely discovery and initial evaluation of candidate repurposed
medications for AUD and AALD. In Aim 1 we apply Explainable Artificial Intelligence methods and systems
biology to data from the national Veterans Administration Healthcare (VA) electronic health record linked to
genetic data and public data to identify candidate repurposed AUD and AALD medications in the context of
gene networks, which may provide mechanistic details at the biological level. In Aim 2 we use data from the
well-characterized VA family of cohorts encompassing >60,000 PAH and millions of uninfected controls, to
conduct propensity score matched analyses to examine the safety and effectiveness of four candidate
medications (prazosin, pioglitazone, and verapamil for AUD and metformin for AALD) among PAH and
uninfected individuals. In Aim 3, informed by these analyses, our prior alcohol interventions in HIV treatment
settings, and in collaboration with the Risk Communication and Administrative/Data Analytic Cores, we will
conduct three pilot studies employing clinical pharmacist-delivered personalized risk messaging and identified
candidate medications to generate time sensitive data on the feasibility, acceptability, and efficacy of these
medications to address AUD or AALD. Together, these studies will collectively expedite the pipeline from
discovery to evaluation of novel medications to address AUD and AALD among PAH.

## Key facts

- **NIH application ID:** 10686388
- **Project number:** 5P01AA029545-03
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** E. Jennifer Edelman
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $530,763
- **Award type:** 5
- **Project period:** 2021-09-10 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10686388

## Citation

> US National Institutes of Health, RePORTER application 10686388, Safety and Effectiveness of Medications for Alcohol Use Disorder among HIV+/- (5P01AA029545-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10686388. Licensed CC0.

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