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Modify HOPE Act variance to include other organs

Proposal Overview

Status: Board Approved

Sponsoring Committee: Ad Hoc Disease Transmission Advisory Committee

Strategic Goal: Increase the number of transplants

View the policy notice (PDF; 6/2019)

View the Board report (PDF - 477 K; 6/2019)

Read the proposal (PDF; 1/2019)

Contact: Emily Ward

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

LifeGift | 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.

Anonymous | 02/08/2019

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

LifeQuest | 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.

Anonymous | 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

Anonymous | 02/21/2019

Region 5 Vote: 13 strongly support, 20 support, 1 abstain

Anonymous | 02/21/2019

Region 2 Vote: 11 strongly support, 15 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 02/26/2019

Region 8 vote: 8 strongly support, 13 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 02/28/2019

Region 10 Vote: 14 strongly support, 10 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 03/13/2019

UNOS/OPTN currently allows kidneys and livers donated by HIV-positive donors to be given to HIV-positive patients in need of a transplant. This program requires an Institutional Review Board-approved research protocol to evaluate the safety and effectiveness of these donor organs. Short term analyses suggest organ transplant outcomes in HIV patients are comparable to outcomes in non-HIV infected recipients. Therefore, UNOS/OPTN is proposing to expand this program to allow other organs to be transplanted, including the heart and lungs. STS supports this proposal. It would increase the donor pool, addressing the critical shortage of donors for heart and lung waitlist patients who are HIV positive. Experience from centers within our membership suggests that heart and lung transplant outcomes in HIV infected recipients have been favorable. As OPTN/UNOS expands the program, STS reiterates the need to use the Universal Precautions to avoid harm to caregivers both during the donor and recipient operations and that OPTN/UNOS continually review policies and practices to ensure safe utilization of HIV-positive organ donors.

Anonymous | 03/14/2019

The Organ Procurement Organization (OPO) Committee is in support of this proposal. OPO Committee Vote: 6 Strongly Support, 2 Support

Anonymous | 03/15/2019

The OPTN/UNOS Patient Affairs Committee (PAC) appreciates the Ad Hoc Disease Transmission Advisory Committee’s (DTAC) efforts to increase the number of transplants by expanding the HOPE Act variance to include other organs. The PAC noted the following: • All candidates stand to benefit from this proposal. Those eligible to receive an organ from a donor with HIV will likely experience decreased waiting time; particularly significant because people with HIV are often from underserved and vulnerable populations. • Expanding the pool of available organs decreases waiting time for all recipients. Although the full scope of impact is unknown as data is not currently collected, more HIV-positive recipients will have the opportunity to realize the gift of life and the proposal would allow OPTN/UNOS to identify trends across varied research studies and identify potential patient safety factors. • There was no specific language in the proposal that addresses HIV-positive living donors and it was unclear whether living donors were included in the original 2015 HOPE Act variance language. • Family members of candidates may experience a decreased caregiver burden if their loved experiences a shorter waiting time to transplant and improved quality of life. Indirectly, families of donors with HIV may benefit from increased hope and purpose to their desire to donate. Honoring each gift regardless of HIV status increases equity for these families and allows them to share equally from the opportunity to donate organs. • There is a long list of acronyms that should be explained for the general patient population in more detail, rather than just simply spelling them out once. The PAC recommends footnoting ALL of these acronyms along with brief explanations of what these organizations do. The general public cannot be expected to understand the proposal without defining these acronyms and clarification on why they are in the proposal to begin with. Additionally, a lay public audience will be confused without clearly defined terminology for words such as “vessels” & “en-bloc”, as well as by referrals to established policy without direct links to the referred policy. The PAC commends the DTAC for professional society outreach and noted that those numerous stakeholder organizations supported the proposal. However, it does not appear the DTAC collaborated with or reached out to any specific patient advocacy groups, although the impetus for this proposal did originate from the HIV+ community to expand the current variance. The PAC asked the following questions, which were answered by the sponsoring committee’s presenter to the satisfaction of the Committee: Q: Why pediatric populations weren’t considered within the HOPE Act; will these patients also be able to benefit from this proposal? A: The speaker theorized that the NIH document excluded references to HIV positive pediatric transplants due to a lack of experience in current HIV pediatric recipients receiving HIV negative pediatric donor organs. The speaker agreed to provide further details to Committee members as to why the public comment proposal did not reference pediatric candidates at a later date. Q: Why was living donation not referenced in the proposed policy language? A: The public comment proposal intentionally excluded language regarding living donation because there was a sense from the Ethics Committee that living donors would be willing to come forward and donate to HIV positive candidates. The only obvious limitation for living donors would be that except for liver and kidneys, there are few other organs that could be livingly donated. Q: What is the future viability of the current HOPE Act variance if approved after 2020? A: The speaker highlighted that comparative outcomes data from HIV negative and HIV positive donors will be presented to the HHS Secretary. From there, the Secretary would have authority as to whether the HOPE Act remains a research initiative or becomes a new standard of care (similar to Hepatitis C transplantation now). However, there is a lack of knowledge on the measurements that will be used to judge the HOPE Act as a program worth continuing in the future. Q: How will OPTN members achieve transparent reporting of HOPE Act outcomes & research back to the community, patients and donor families? A: There are two pathways in which this may be accomplished: transplant programs presenting outcomes data through public forums (such as symposiums) and the OPTN releasing their own data (such as research abstracts). The speaker noted that a lack of transparency with the public and OPTN community was a fair criticism, and that transplant programs should foster more robust reporting mechanisms in the transplant community. Q: What procedures are in place to not only notify and consent candidates beyond acceptance of an HIV-positive organ, but also acknowledge of continued participation as a research subject with full knowledge of patient rights in participating in an IRB sanctioned study? A: To be approved for the HOPE Act, the candidate needs to have met the requirements set forth by the research institution. For example, once a research institution’s IRB has approved participation within the HOPE Act, then that institution will analyze the consent process and institute their own research guidelines. The speaker did not necessarily think that the OPTN needed to become involved in the process of research consent. Q: Identification credentials were undefined for the second person to verify the candidate’s willingness to accept an HIV positive organ. Is this a verified family member, patient advocate, or a medical transplant center professional as witness? A: Currently, there is a lack of standardization with verification amongst transplant centers participating in the HOPE Act. The only stipulation made by the NIH is that the second person verifying must have experience and understanding of HIV transplant and not be on the study team. For example, the presenter’s center employs an independent HIV advocate separate from the living donor team. However, the speaker acknowledged that the strict standards for second person verification may result in few qualified people. Q: Will there be any special organ labeling and handling that OPOs must do? Is there a benefit to having special packaging and labeling of HIV positive organs? A: Part of the NIH guidelines specify that OPOs must have their own protocols and operation manuals in place (such as for needle-stick injuries). In theory there should be specific labels for HIV positive organs, but the OPTN already has policies in place dealing with disease transmission and organ handling (such as with Hepatitis C organs). Furthermore, since the transplantation of HIV positive organs is so rare, there is heightened awareness in the handling of these organs when such a transplant does occur. However, if these organ transplants increase in the future, then speaker noted that the OPTN should consider how safety precautions can be maintained. Q: Living Donors should be considered as human participants during these research trials. As such, are there any special requirements for them in the HOPE Act? A: The speaker agreed that living donors are human participants during research trials, and that transplant centers have independent consents stating such. Furthermore, built into the original NIH guidelines are clear pre-transplant and post-transplant follow-up protocols for living donors. The speaker went on to note that there have been no living donor HIV positive transplants that occurred in the U.S. and only one in South Africa. Q: Are HOPE Act programs informing the community (both living donors and those potential recipients) that there are different strains of HIV? A: Transplant centers do inform living donors and recipients on receiving an HIV positive organ during the informed consent process, however more focus is placed on which HIV medications the donor and recipient are on. The reasoning behind this is that viruses may have different antibiotic resistance, though the research behind which resistance pattern takes precedence is still being researched. Lastly, it was noted that the HIV 2 strain is rare in the U.S. Q: How do patients know which centers have better outcomes under the HOPE Act? What is the transparency level for each center participating? A: The speaker responded that outcomes data for HIV positive organ transplantation is difficult to ascertain because the sample size is too small per center. It would be a challenge for patients to find center-specific data, and the outcomes for each center. Q: What patient population would benefit from this policy proposal, specifically in regards to Waitlist? A: The speaker did not specifically know the benefits, because there is no current Waitlist for HIV positive candidates and they are not required to report their HIV status when registering for an organ. In Summary, • The appropriate measurements are in place to guide the evaluation of this policy • Candidates maintain the option to opt in or refrain from participating • It could decrease the waitlist for all candidates • May allow some recipients & their caregivers to attain a higher-level quality of life For these reasons, the PAC unanimously supported this proposal as it creates a valuable new source of organs and can save lives. It prevents the discard of HIV false-positive organs and provides increased opportunity to candidate populations who are typically underserved.

Anonymous | 03/15/2019

Vote: 16 strongly support, 12 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Valinda Jones | 03/15/2019

I fully agree with and support all of the comments previously submitted by the Patient Affairs Committee and other professional groups.

Donor Alliance | 03/15/2019

Donor Alliance strongly supports the expansion of the HOPE Act to include additional organs for transplantation.

AOPO | 03/17/2019

The Association of Organ Procurement Organizations support the expansion of the OPTN/UNOS HOPE Act Variance to allow programs meeting the requirements to recover and transplant organs in addition to liver and kidney. We are pleased to be able to maximize the gift of life through organ donation to those testing positive for HIV, provide additional lifesaving organs for HIV positive candidates and subsequently expand access to all who wait.

HOPE in Action Multicenter Consortium | 03/19/2019

The HOPE in Action team fully supports modification to the HOPE Act variance which allows additional HOPE donor organ transplants beyond kidney and liver. We applaud UNOS/OPTN for this important step forward. With the expansion of HOPE to include more organs for transplant, ensuring utilization of these donor organs is critical. Transplant centers need further guidance regarding the experience requirement for combined kidney-pancreas transplant. The NIH has informed us that UNOS/OPTN is qualified to determine whether HIV+ kidney transplant experience would qualify a center to perform HIV+ donor combined kidney-pancreas transplantation. Our multicenter team of HIV transplantation experts feels strongly that centers with sufficient HIV+ kidney transplant experience should also be allowed to perform HIV+ donor kidney-pancreas transplant. Christine Durand MD, Dorry Segev MD PhD, Peter Stock MD PhD, and Sander Florman MD On behalf of the HOPE in Action Multicenter Team

Anonymous | 03/19/2019

To Whom it May Concern, On behalf of the American Nephrology Nurses Association (ANNA), thank you for allowing us the opportunity to comment on the Organ Procurement and Transplantation Network (OPTN) Public Comment Proposals 01/22/19- 03/22/19. Our comments for several of the current policy proposals are as follows: OPTN Standards for Public Comment 01/22/19 – 03/22/19 Modify HOPE Act variance to include other organs: ANNA supports.

American Society of Transplantation | 03/19/2019

The American Society of Transplantation is supportive of this policy change, and offers the following comments: • Consideration of future inclusion of testing for Donor HIV drug resistance. Although results will not likely be available at the time of allocation, it would be helpful in the management of the recipient after organ transplantation. • Suggestion to include in the policy of the exact number of “NIH required number of HIV- to HIV+ transplants” per organ over which time frame rather than referring to another resource document. • Given the small volume of transplants anticipated under this policy, the impact on outcomes monitoring is likely able to be managed with current resources. Budgetary impact on participating centers is more difficult to access.

American Society of Transplant Surgeons | 03/21/2019

The American Society of Transplant Surgeons (ASTS) strongly supports expansion of the HOPE Act variance to other organs. To date there have been approximately 110 transplants performed using organs from HIV+ donors into HIV+ recipients. In addition, there have been approximately 25 transplantations done using organs from donors who initially tested positive for HIV and found later to be a false positive (an event also facilitated by the HOPE Act). These organs were transplanted into HIV+ recipients as they are the only individuals that appear on these match runs (see: AJT 2018;18:2579-2586). Early outcomes appear excellent, with one graft failure and one patient death reported to OPTN as of mid-2018. Expansion of the HOPE Act to thoracic organ candidates is a logical extension of this policy. There are no obvious unique aspects of heart or lung transplantation that would make use of HIV+ donor organs (including their procurement, transplant, and outcomes monitoring) substantially different from liver or kidney transplantation. There are likely fewer HIV+ heart and lung candidates, although the true need for thoracic organ transplantation is not known as HIV infection has been considered by most centers as a contraindication to heart and lung transplantation. There are in fact rare but unique examples of thoracic end-organ damage (HIV cardiomyopathy, and HIV-associated COPD) that occur in HIV infected individuals for which future access to transplant would be essential.

International Society for Heart and Lung Trasplantation | 03/21/2019

The International Society for Heart and Lung Transplantation (ISHLT) is a multidisciplinary, professional membership society dedicated to improving the care of patients with advanced heart or lung disease through transplantation, mechanical support and innovative therapies via research, education and advocacy. The nearly 4000 members of the Society include professionals from over 45 countries, representing 15+ different disciplines involved in the management and treatment of end-state heart and lung disease in both children and adults. Approximately 70% of the society’s members practice in the United States. The OPTN proposed modification to the HIV Organ Policy Equity (HOPE) Act to allow programs meeting the research and experience requirements to recover and transplant thoracic organs from HIV-positive donors into HIV-positive candidates. The Federal HOPE Act, originally passed in 2013, allows organ transplantation from HIV-positive donors into HIV-positive recipients. The current proposal expands this to thoracic organs, which is consistent with the original intent of the Act. ISHLT is fully supportive of this modification. We believe that this will improve access to transplantation for a traditionally underserved and vulnerable patient population. We agree with the stipulations that thoracic transplants from HIV-positive donors into HIV-positive recipients should be performed at programs with appropriate clinical experience in transplantation and HIV care and sufficient research infrastructure to report detailed outcomes and expand the knowledge base for the heart and lung transplant community. While access to HIV-positive donors and broadening the donor pool for HIV-positive recipients are the centrals aims of the HOPE Act, we believe that safe guards must be maintained such that HIV positive recipients also have equal access to non-HIV positive donors. We believe that with appropriate donor and recipient selection, outcomes after transplantation of HIV-positive donor organs into HIV-positive recipients would likely be equivalent to outcomes after traditional heart and lung transplantation. Nevertheless, appropriate reporting of these data will be necessary such that future clinical decisions will be evidence-based. ISHLT appreciates the opportunity to respond to the proposed policy and to provide feedback that we anticipate will contribute to the development of a meaningful improvement in organ transplantation.

Carolina Donor Services | 03/22/2019

Carolina Donor Services strongly supports the expansion of the Hope Act variance to include transplantation of organs beyond kidney and liver.

Anonymous | 03/22/2019

25 strongly support, 17 support, 1 abstain

Anonymous | 03/22/2019

13 strongly support, 12 support, 3 abstain

Anonymous | 03/22/2019

Vote: 9 strongly support, 13 support, 1 abstain, 0 oppose, 0 strongly oppose

Anonymous | 03/22/2019

The American Society for Histocompatibility and Immunogenetics (ASHI) strongly supports this proposal.

Anonymous | 03/22/2019

The Transplant Coordinators Committee reviewed the proposal during a conference call on March 20, 2019. The members support the initiative to expand the Variance to include other organs as this directly contributes to the OPTN’s Strategic Goal of increasing organ transplants. Members supported the development of a prominent visual cue in DonorNetSM for human immunodeficiency virus (HIV) positive organ donors in order to clearly identify the donor’s HIV sero-status. This visual cue, akin to the prominent visual cue currently in use to denote a donor’s blood type, would serve a patient safety role to transplant staff that the offered organs are from a HIV positive deceased donor and are being offered to similar sero-status potential recipients at a transplant program. Also, this cue would serve as a reference and save time navigating to other tabs or attachments in DonorNet to identify the donor’s HIV sero-status. The Committee appreciates the opportunity to provide feedback to the Disease Transmission Advisory Committee.

S Little | 03/23/2019

After proposal review, I support the proposed modification to the HOPE Act variance, which would allow for additional HOPE donor organ transplants. This would ensure more utilization of such a sacred gift. This is critical – if possible, using resources to the fullest potential overall helps more individuals. I do agree with the comments made about maintaining HIV-positive recipients must also have equal access to non-HIV positive donors.

Joseph Hillenburg | 03/23/2019

This proposal is a positive step for the reasons mentioned by many above (including the Patient Affairs Constituent Council). Just making use of organs classified as false positives alone is an important step in increasing utilization, but this proposal is also important from an equity standpoint.

E. Rubinstein | 03/23/2019

I strongly support the expansion of the HOPE Act to allow transplantation of other HIV organs (heart, lungs, all organs) in addition to currently allowed kidney and liver HIV-positive organs. Having participated in the evaluation of the proposal within the OPTN Patient Affairs Committee, the value of utilization of HIV positive organs with noted suggestions from the PAC evaluation (Please see Public Comment Posting) opens equitable access to a greater HIV population and fulfills the original intent of the HOPE act.

Anonymous | 03/26/2019

Vote: 6 strongly support, 16 support, 0 abstain, 0 oppose, 0 strongly oppose