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§ Current policy prohibits recovering or transplanting
an organ from a deceased donor with HIV
§ HIV Organ Policy Equity Act (HOPE Act)
§ Enacted 2013 § Permits research into transplanting organs from HIV
Addressing the Requirements Outlined in the HIV Organ Policy Equity - - PowerPoint PPT Presentation
Addressing the Requirements Outlined in the HIV Organ Policy Equity - - PowerPoint PPT Presentation
Addressing the Requirements Outlined in the HIV Organ Policy Equity Act Organ Procurement Organization Committee Spring 2015 The Problem Current policy prohibits recovering or transplanting an organ from a deceased donor with HIV
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To continue to amend OPTN policies to allow members to participate in a research study
Goal of the Proposal
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§ Unanimously supported by regions § Supported by all committees that reviewed/
commented
§ Supported by the ASTS, AST, the HIV Positive
Women’s Network, and the HIV Medicine Association
§ The AST and Kidney Transplantation Committee
expressed concerns about including living donors in research study
Fall 2014 Hope Act Proposal
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- Nov 2013:
Hope Act enacted
Sept-Dec 2014: first round public comment
- Jan-March
2015: second round public comment
June 2015: OPTN Board will consider initial changes
- Summer
2015: possible additional PC period
Nov 2015: Hope Act effective
HOPE Act Timeline
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§ Applies only to liver and kidney transplants § Initial proposal created a new section (Policy 15.3)
to address HIV transplants
§ New proposal creates an open variance for the
recovery and transplantation of HIV positive organs in a new section of policy (Policy 15.5)
¡ ¡
Current Proposal
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§ Variance establishes:
§ specific requirements for allocating HIV positive deceased
and living donor livers or kidneys
§ transplant hospital requirements for transplanting HIV
positive organs
§ Includes two-person verification process that
potential HIV positive candidate is willing to accept HIV positive liver or kidney
¡ ¡
Current Proposal
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§ Current proposal includes several terminology
changes
§ Policy 2.7.A – changes “informed authorization” to
“informed consent”
§ Policies 15.4.A, 16.7.C, and 16.7.E – changes
“serology results” to “infectious disease testing results”
¡
Current Proposal
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Proposed: living kidney and liver donors would be eligible to donate as part of the research study
§ The Committee is seeking requests for comments
regarding the inclusion of living donors in research study
Current Proposal
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Proposed change to Policy 5.4.F: HIV positive
- rgans will not be allocated to candidates who do
not appear on the match run
§ Restriction could negatively impact directed donation to
candidates who do not appear on the match run
§ Seeking specific feedback on how to handle directed
donations of HIV organs when the intended recipient does not appear on the match run based on ABO
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Current Proposal
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Other proposed changes:
§ Add “willing to accept an HIV positive liver” to
liver acceptance criteria policy (5.3.C)
§ Revise informed consent requirements in Policy
15.3 (Informed Consent of Transmissible Disease Risk) to include HIV
§ Revise previously proposed changes to the
vessel storage policy
Current Proposal
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§ The Disease Transmission Advisory Committee
(DTAC) will address in a separate proposal re- execution of match runs based on updated infectious disease testing results
§ Does not currently include changes to the organ
labels or infectious disease testing verification
Additional Info
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§ Allows recovery and transplantation of HIV positive
- rgans as part of research study; initial study
limited to kidney and liver
§ Provides protections and safeguards for donors
and recipients
How the Proposal Will Achieve its Goal
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§ OPOs will need to develop processes for allocating
HIV positive organs to HIV positive candidates
§ Transplant centers must notify the OPTN contractor
if participating in an IRB approved research protocol that meets the requirements in the Final Rule regarding the recovery and transplantation of HIV positive organs ¡
What Members will Need to Do
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§ Members must not store extra vessels from HIV
positive donors
§ Transplant centers must complete a two-person
reporting and verification process in order for HIV positive candidates to appear on the match run
§ Transplant programs must obtain specific informed
consent before transplant of HIV positive organs
What Members will Need to Do
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§ Sean Van Slyck
Committee Chair svanslyck@ctdn.org
§ Regional representative name (RA will complete)
Region X Representative email address
§ Robert Hunter