# Project 1-Cohort/Ethics Study of Patients with Severe Alcoholic Hepatitis undergoing Early Liver Transplantation

> **NIH NIH P50** · JOHNS HOPKINS UNIVERSITY · 2024 · $268,604

## Abstract

Project Summary
In 2021, Alcoholic Liver Disease (ALD) accounted for 37% of liver transplants (LTs) performed in the United
States. Given concerns for relapse in alcohol use post-transplant, most centers require that candidates have
been abstinent from alcohol use for 6-months prior to being placed on the waitlist for transplant. However, a
subset of patients present with severe alcoholic hepatitis (SAH) refractory to medical management and with a
3-month mortality of 70-80% without LT. This dire situation precludes the possibility of a 6-month wait period.
Early LT (ELT) is the only life-saving treatment available for these patients, however, access to this
practice is limited, due to a lack of national consensus on criteria for listing and transplant. We
conducted a pilot study of ELT for SAH. In our initial experience, candidates with SAH who underwent liver
transplant prior to a 6-month wait achieved demonstrated excellent 1-year post-transplant survival and had
identical rates of relapse when compared to LT recipients with 6-month sobriety. Based on these encouraging
findings, we established the DELTA Center (Delivery of Early Liver Transplant for Alcoholic Hepatitis) at Johns
Hopkins University as a specialized alcohol research center. The DELTA center has accrued the world’s
largest cohort of candidates with SAH and ELT recipients in the world. Despite excellent outcomes post-
transplant, we have transplanted a relatively homogenous group of ELT recipient with regards to
sociodemographic factors and it has become clear that access to ELT may not be equitable. Continued work
through our DELTA Center will now focus on continued expansion of ELT with a focus on understanding the
impact of social determinants of health (SDoH) on access and outcomes in ELT. We will leverage the
resources and experience of the DELTA Center and engage relative stakeholders to build an ethical framework
for ELT that can guide dissemination of this practice to other transplant centers. We propose: 1) To identify
SDoH associated with access to ELT; 2) To quantify longer-term post-transplant outcomes for ELT, up to 10-
years; 3) to identify SDoH associated with post-transplant outcomes assess; and 4) To establish an ethical
framework for considering ELT for SAH based on the opinions of SAH patients, transplant providers, and the
general public about this practice, ultimately resulting in a new rational national policy on ELT for SAH. This
study represents the largest and longest prospective cohort study of ELT for SAH. Our findings will
have an immediate and direct impact on the practice of ELT for SAH in the United States, informing
critical aspects of candidate selection, overcoming barriers to access, informed consent, post-LT care and
national policy. Robust quantification of the impact of SDoH on ELT for SAH is novel and necessary to ensure
equity. A better understanding of this emerging treatment is essential for improving care of patients with SAH
and will hel...

## Key facts

- **NIH application ID:** 10741444
- **Project number:** 2P50AA027054-06
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** ANDREW M. CAMERON
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $268,604
- **Award type:** 2
- **Project period:** 2019-02-01 → 2029-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10741444

## Citation

> US National Institutes of Health, RePORTER application 10741444, Project 1-Cohort/Ethics Study of Patients with Severe Alcoholic Hepatitis undergoing Early Liver Transplantation (2P50AA027054-06). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10741444. Licensed CC0.

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