Addressing the Requirements Outlined in the HIV Organ Policy Equity Act Organ Procurement Organization Committee Spring 2015

 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 positive donors to HIV positive recipients The Problem

To continue to amend OPTN policies to allow members to participate in a research study Goal of the Proposal

 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

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

 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

 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

 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

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

Proposed change to Policy 5.4.F: HIV positive organs 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 Current Proposal

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

 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

 Allows recovery and transplantation of HIV positive organs 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

 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

 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

 Sean Van Slyck Committee Chair  Regional representative name (RA will complete) Region X Representative address  Robert Hunter Committee Liaison Questions?