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Modify HOPE Act variance to include other organs

Proposal Overview

Status: Public Comment

Sponsoring Committee: Ad Hoc Disease Transmission Advisory Committee

Strategic Goal 1: Increase the number of transplants

Read the proposal (PDF; 1/2019)

Contact: Emily Ward


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Executive Summary

The HIV Organ Policy Equity Act was enacted on November 21, 2013, permitting use of organs from HIV- positive donors for transplantation into HIV-positive candidates under approved research protocols designed to evaluate the feasibility, effectiveness, and safety of such organ transplants. In November 2015, OPTN/UNOS policies for recovery and transplantation of HIV positive livers and kidneys to HIV-positive candidates were effective, in addition to final research requirements for program participation, published by the National Institutes of Health (NIH).

This proposal modifies the policies enacted by the OPTN/UNOS HOPE Act Variance to allow programs meeting the research and experience requirements to recover and transplant organs in addition to liver and kidney. Program participation requirements, including meeting minimum experience, operating under an approved Institutional Review Board (IRB), and adhering to the federal research protocol guidelines, remain unchanged.

No clinical outcomes that may threaten the safety of such transplants have been reported to the OPTN/UNOS since 2015. Expansion of the variance to include other organs besides kidney and liver has been requested by active program participants. Federal criteria do not limit the program to specific organ transplants, and explicitly encouraged future expansion of the program upon publishing research study participation criteria in November 2015.

Comments

Kevin Myer | 01/30/2019

As an OPO that is actively involved in the very important OPTN/UNOS HOPE Act Variance, we totally support the inclusion of other organs in this project. We also encourage and support the increase in transplant center participation in this variance.

Region 7 | 02/08/2019

Region 7 vote-10 strongly support, 1 support, 1 abstain

Danielle Balbis | 02/11/2019

LifeQuest strongly supports the inclusion of other organs associated with the HOPE Act.

Robert Goodman | 02/12/2019

I am in agreement that the variance provided for in the past known as the HOPE Act should now be expanded to include other organs. I believe the safety and efficacy of what has thus far been shown speaks to the reason for expansion.

OPTN/UNOS Thoracic Committee | 02/15/2019

The OPTN/UNOS Thoracic Organ Transplantation Committee commends the Ad Hoc Disease Transmission Advisory Committee’s (DTAC) efforts to facilitate policy changes enacted by the OPTN/UNOS HOPE Act Variance to allow programs meeting the research and experience requirements to recover and transplant organs in addition to liver and kidney. Members thought this was appropriate, overdue and should be generally well-received within the thoracic organ transplantation community. One member asked about the experience requirements in the NIH research protocol. Programs may have experience caring for a larger volume of potentially eligible patients who have since moved on from receiving care from that program.[1] Would that program be eligible to apply? The presenter cited that the requirements were phrased in a way that allowed programs some latitude in how collective experience was accumulated.

Region 1 | 02/18/2019

Region 1 vote-8 Strongly support, 6 support, 0 abstain, 0 oppose, 0 strongly oppose