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Multidisciplinary approach to study of patients with Severe Alcoholic Hepatitis Undergoing Liver Transplantation

Award Number: P50AA027054
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2019
PERIOD OF PERFORMANCE END DATE: 05/31/2029

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Multidisciplinary approach to study of patients with Severe Alcoholic Hepatitis Undergoing Liver Transplantation - 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 could be improved. Continued work through our DELTA Center will now focus on continued expansion of ELT with a focus on understanding the impact of all factors that determine access and outcomes in ELT. We will leverage the resources and experience of the DELTA Center and engage stakeholders to build an ethical framework for ELT that can guide dissemination of this practice to other transplant centers. We propose: 1) To identify patient level factors that determine access to ELT; 2) To quantify longer-term post-transplant outcomes for ELT, up to 10-years; 3) to identify clinical and non-clinical factors associated with post-transplant outcomes; 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. A better understanding of this emerging treatment is essential for improving care of patients with SAH and will help improve the feasibility, availability and quality of care we provide to this vulnerable patient population.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $1,694,816 )
2025	2025	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	001	7	9/9/2025	NON-COMPETING CONTINUATION	$1,694,816
2025	2023	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	000	5	11/19/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,694,816

Issue Date FY: 2024 ( Subtotal = $1,694,816 )
2024	2024	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	001	6	6/3/2024	COMPETING CONTINUATION	$1,694,816
2024	2023	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	002	5	6/3/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2023	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	000	5	6/3/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,694,816

Issue Date FY: 2023 ( Subtotal = $1,736,736 )
2023	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	002	5	9/6/2023	SUPPLEMENT FOR EXPANSION	$132,949
2023	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	003	5	9/14/2023	NON-COMPETING CONTINUATION	$0
2023	2023	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	001	5	2/6/2023	NON-COMPETING CONTINUATION	$1,603,787
2023	2022	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	000	4	11/29/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,736,736

Issue Date FY: 2022 ( Subtotal = $1,621,184 )
2022	2022	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	000	4	2/1/2022	NON-COMPETING CONTINUATION	$1,459,063
2022	2022	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	001	4	6/23/2022	NON-COMPETING CONTINUATION	$162,121
														Subtotal = $1,621,184

Issue Date FY: 2021 ( Subtotal = $1,635,108 )
2021	2021	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	001	3	9/28/2021	NON-COMPETING CONTINUATION	$0
2021	2021	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	000	3	2/18/2021	NON-COMPETING CONTINUATION	$1,635,108
														Subtotal = $1,635,108

Issue Date FY: 2020 ( Subtotal = $1,665,534 )
2020	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	001	2	5/13/2020	NON-COMPETING CONTINUATION	$0
2020	2020	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	000	2	1/31/2020	NON-COMPETING CONTINUATION	$1,665,534
														Subtotal = $1,665,534

Issue Date FY: 2019 ( Subtotal = $1,682,041 )
2019	2019	JOHNS HOPKINS UNIVERSITY, THE	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	000	1	1/21/2019	NEW	$1,682,041
														Subtotal = $1,682,041

Grand Total All Awards = $11,730,235

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Multidisciplinary approach to study of patients with Severe Alcoholic Hepatitis Undergoing Liver Transplantation

Award Number: P50AA027054

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/01/2019

PERIOD OF PERFORMANCE END DATE: 05/31/2029

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