University of California San Diego (UCSD) Last Gift Team
We are writing in strong support of removing the research requirements for liver and kidney PWH-to-PWH transplants. We believe HIV transplants should become standard of care for PWH and end-stage organ disease. Transplanting PWH with organs from donors also diagnosed with HIV helps free up deceased donor organs for the next people in line awaiting organ transplants, regardless of their HIV status.
Currently, PWH in need of kidney and liver transplants can only go to 30 transplant centers (instead of 250).
These organ transplants should become standard of care to reach their maximum public health impact, and to benefit everyone needing an organ transplant – either living with or without HIV.
The HIV community is extremely altruistic and willing to help other PWH. We believe organ transplants should become standard of care as soon as possible.
Sincerely,
Karine Dubé, Sara Gianella and Jeff Taylor, UCSD Last Gift Team
San Diego, California
American Sexual Health Association
The American Sexual Health Association (ASHA) would like to submit our support for making HIV-to-HIV organ transplants standard of care for patients with HIV and end-stage organ disease. Transplanting HIV patients with organs from donors diagnosed with HIV helps free up deceased donor organs for the next person waiting, regardless of HIV status.
HIV patients in need of kidney or liver transplants can only currently go to 30-something centers (out of 250) for HOPE transplants, so taking them out of research and making them standard of care will benefit and increase HIV-to-HIV transplant implementation, and thus benefit everyone waiting on a kidney or liver transplant.
Please feel free to contact me if you have any questions.
Best,
Lynn Barclay
President and CEO
American Sexual Health Association
C. Todd Fuqua
I’m writing to support making HIV-to-HIV transplants standard of care for patients with HIV and end-stage organ disease.
I’m writing in as a person living with HIV who has seen how organ transplants can save lives through several national-level organ recipient activists in my community here in Indiana. I attended a fundraiser for the Indiana Donor Network and was moved by the stories shared.
I’ve also learned through the HOPE Act, individuals living with HIV are eligible to donate organs to other people living with HIV. However, the current arrangement comes with strings and barriers because of the research requirements of the HOPE Act.
Please remove the research requirements in favor of a standard of care.
Transplanting HIV patients with organs from donors diagnosed with HIV helps free up deceased donor organs for the next person waiting, regardless of HIV status. Making them standard of care will benefit and increase HIV-to-HIV transplant implementation, and thus benefit everyone waiting on an organ transplant, living with HIV or not.
Thank you for your consideration,
Sawubona,
C. Todd Fuqua
Indianapolis, IN
Dr. Carrie Foote
Hello,
I have been living with HIV for 34 years. It has been incredible watching the advances in HIV-science since I was diagnosed in 1988 that have transformed HIV from a terminal disease to a chronic manageable illness with minimal impact on life expectancy, when treated. I am alive today because of these advances. Especially groundbreaking has been the advances in organ donation for people living with HIV. The fact that we can save lives and increase the pool of organs available for people living with HIV, and indirectly, for all, is incredible. The HOPE act has been collecting data for years and has shown the safety of HIV+ to HIV+ organ donation. It is time to remove the research restrictions and allow this to become standard care for people living with HIV. Removing those restrictions is a win-win for everyone waiting for an organ regardless of whether they have HIV or not.
Thank you,
Dr. Carrie Foote
Woman living with HIV since 1988
Professor of Sociology, Indiana University-Indianapolis
Chair of the HIV Modernization Movement-Indiana
Nina Martinez
I am writing today, November 7, 2022, to comment in support of the draft recommendation put for discussion before the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) related to the implementation of the HIV Organ Policy Equity (HOPE) Act of 2013.
A survivor of transfusion-acquired human immunodeficiency virus (HIV) 39 years ago, I grew up to serve as a public health analyst at the Centers for Disease Control and Prevention after pursuing graduate studies in epidemiology at Emory University. I am now a public health consultant, the country's first living kidney donor with HIV, a registered deceased organ donor, and I completed a living partial liver donor evaluation in November 2021. I have previously been a community educator and recruiter for the Atlanta research site of both the HIV Vaccine Trials Network and the Vaccine and Treatment Evaluation Units. Lastly, I was fortunate to be a dedicated 19-year clinical research volunteer at the National Institutes of Health, having recently completed follow-up in a 10-year study of clinical outcomes in people who acquired HIV within the first decade of life.
There is no single source of publicly available information for people living with HIV, who are seeking to donate or receive an organ, that states any transplant program approved under the Organ Procurement and Transplantation Network (OPTN)’s HOPE Act variance is actively pursuing the recovery of organs from donors diagnosed with HIV or performing transplants with these organs. (optn.transplant.hrsa.gov/media/ex3bmasx/hope-act-hospitals.pdf, last updated October 2022) A news release or one-off promotional video by a transplant program posted to its own webpage is not evidence of, nor substitute for, current and active outreach, education, phone and clinical screening, and enrollment into a research study. The general public should know that people living with HIV can register and do become organ donors year-round, not just during Pride Month in June and World AIDS Day, December 1, when organ procurement organizations and transplant advocacy organizations can be bothered to mention it for inclusivity bonus points.
Championing the full implementation of the HOPE Act in clinical practice should increase the number of donors identified as having an HIV diagnosis and, with the cooperation of open-minded organ procurement organizations and transplant programs, increase access to organ transplants for everyone. All transplant candidates benefit when people living with HIV are transplanted because active HIV-to-HIV transplant programs free up the next available organ from a deceased donor not diagnosed with HIV, which then goes to the next patient waiting for a transplant. Every effort should be made to make information about the legality and real-time implementation of the HOPE Act available for public consumption at organdonor.gov.
Moreover, I want to explicitly advocate for the U.S. Department of Health and Human Services (HHS) to take HIV-to-HIV transplants out of research because it is about time we do so, particularly about reducing time for everyone waiting on a life-preserving transplant. Keeping HIV-to-HIV transplants restricted as “research” when many experimental questions have already been settled (at least for liver and kidney) has rendered these transplants optional, rather than imperative, at current programs selectively approved under the OPTN HOPE Act variance. People living with HIV looking to access the so-called expanded pool of donors at selected transplant programs – if they are lucky enough to find out about it in the first place – likely have to travel for it; I had to travel to Baltimore four times in total to donate. Combined with suboptimal implementation, this further reduces the transplant equity legalization was supposed to achieve.
Competing research priorities like the ongoing coronavirus pandemic response have indeed left HOPE Act-related research as an afterthought. It was originally estimated that legalizing HIV-to-HIV transplants could result in an additional 500–600 deceased donors per year. We know with certainty that we are nowhere close to meeting that potential after a nearly seven-year period of implementation, averaging currently maybe 50 donors per year. If the field of transplantation is not going to do the education and research they were supposed to do, at the scale in which it was predicted, then they need to stop pretending that passage of the HOPE Act was a move for transplant equity and admit they are currently offering a choice on how people living with HIV and end stage organ failure die while waiting: whether that is waiting on an HIV-positive organ offer or an HIV-negative organ offer.
Patients with HIV on a transplant waitlist want to know why the field of transplantation does not merit evolution of clinical practice, seemingly only for them, that keeps up with emerging science. With the evidence that has been gathered over the last fourteen years, HIV-to-HIV transplants have proven safe and acceptable for patients in South Africa and the U.S. How many more NIH-funded literature reviews on HIV-to-HIV transplants do we need that rehash the 2013 U.S. legalization effort, and why could those dollars not be used on creating and sustaining HIV community engagement, as well as referral and engagement of potential donors and recipients diagnosed with HIV? The idea that federal entities cannot change the transplant standard of clinical care to include people living with HIV and their federally-allowable, legally-binding, first-person authorizations vis-à-vis HIV-to-HIV transplantation is absurd when we have catastrophic organ waste.
The HHS-wide Advisory Committee on Organ Transplantation (ACOT)’s ”Recommendation 66” focused on HOPE Act implementation. Neither the United Network for Organ Sharing nor the Association of Organ Procurement Organizations made strides in adopting this ACOT recommendation, and I would insist that the HHS Secretary, the ACOT, and the OPTN put forth a public response, or at least one to ACBTSA, that includes how they plan to follow-up on this recommendation. (hrsa.gov/advisory-committees/organ-transplantation/recommendations/66-67). They have not scheduled a recent meeting, as of the time of this comment. (hrsa.gov/advisory-committees/organ-transplantation/meetings).
HIV-to-HIV transplants are little more than a possibility in name only, without much implementation by the research teams, organ procurement organizations, and transplant programs required to collaboratively conduct them. These HOPE Act variance approvals exist at less than 15% of transplant programs, for living and deceased donor transplants, combined. The proportion for living donation alone is less than 3%. The majority of approved centers, which may not be active, are east of the Mississippi River. Access to transplants for people living with HIV – who are nearly twice as likely to die while waiting for a kidney – is gatekept more than we already knew.
OPTN is responsible for the safety of the transplant system, regardless whether the HOPE Act variance existed. Yet, their view of safety does not discuss the people with HIV who die waiting on an organ transplant despite the existence of the HOPE Act, like my original intended kidney recipient. What is the value added of sequestering HIV-to-HIV transplants under research that we could not achieve by granting authorization to all transplant programs, as is done with donors diagnosed with Hepatitis C virus? Some transplant programs would be more willing to perform HIV-to-HIV transplants than those currently authorized to do so, were it not for the burdensome federally-mandated research stipulations. There are only three reasons someone would not be a proponent of HIV-to-HIV transplants becoming part of clinical care: 1) you do not have faith that the transplant system will get "right person, right organ" correct, 2) you would rather see people living with HIV and end-stage organ disease die, or 3) you enjoy being funded (to the tune of $24.7 million) for research you do not conduct. What is equitable is allowing transplant programs who want to do these HIV-to-HIV transplants to do them, and to allow the patients who want them to have them. That is equity. I thank the ACBTSA for considering this draft recommendation, and I hope you will support it.
Nina Martinez
Atlanta, Georgia
Organ Procurement and Transplantation Network
November 8, 2022
By Electronic Mail
Claudia Cohn, MD, PhD
Chair, Advisory Committee on Blood and Tissue Safety and Availability
Office of Infectious Disease and HIV/AIDS Policy
U.S. Department of Health & Human Services
330 C Street, S.W.
Suite L100
Washington, D.C. 20024
RE: Fifty Sixth ACBTSA Meeting, Written Public Comment – November 17, 2022 Meeting
Dear Dr. Cohn,
On behalf of the Organ Procurement and Transplantation Network (OPTN), thank you for the opportunity to offer comment on the proposed Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) recommendations to remove the statutory National Institutes of Health (NIH) research criteria for HIV-positive donor to HIV-positive recipient organ transplants performed under the HIV Organ Policy Equity (HOPE) Act in advance of the Committee’s November 17, 2022, meeting.
We are pleased to reiterate our support for the removal of the statutory “NIH Research Criteria” for all organs as first communicated in an October 21, 2022 letter to HHS Secretary Becerra. As noted in our initial letter, the data show these transplants are safe, effective and have the potential to expand the pool of eligible organ donors. We also support removing the IRB requirement for kidney and liver transplants.
We do have concerns with the proposed oversight that would direct the OPTN to develop policies requiring:
- OPTN organ-specific variance for each organ other than kidneys and livers
- Additional organ-specific candidate criteria and transplant program requirements analogous (but not “identical”) to the NIH Research Criteria developed specifically for the unique patient safety and outcomes monitoring characteristics of transplants other than kidneys and livers in HIV patients
- Additional organ-specific OPTN outcomes monitoring for candidates of organs other than kidneys and livers on the Waiting List and recipients following transplantation
- Each center/institution must have an IRB-approved protocol that will include measures of outcomes and safety
- When multiple organs are transplanted simultaneously, the default approach will be to use the guidelines of the organ with more conservative policies
We believe that the current model of the HOPE Act, based on the existing NIH criteria, is appropriate for continued research oversight of non-kidney or liver transplants. In addition, we believe that the OPTN structure and outcome data collected is sufficient in its current state to provide oversight for all organs. The OPTN favors keeping the status quo for non-kidney and non-liver organs if the clinical research and IRB requirements remain rather than creating and implementing new policies, criteria, and models that currently exist elsewhere.
We also hypothesize that the continued IRB requirement for other organs, including thoracic organs, will keep barriers in place that have resulted in the limited number of transplants done for HIV positive heart donors to HIV positive recipients. Removing the NIH Research Criteria and the IRB requirement for only kidneys and livers is likely to perpetuate inequities and disparities between HOPE Act organ program development and negatively impact access to organs for HIV infected recipients in need of a non-kidney or non-liver transplant. Further, HIV-positive individuals may be precluded from access to less common transplant types, such as solitary pancreas or vascular composite allografts not addressed in this proposal, as current experience to guide the development of research criteria and appropriate data collection is limited.
The current structure requiring formal protocol development and IRB approval by transplant programs is limiting in the context of the small number of non-kidney or liver transplants that are likely to be done at any one program. Maintaining an active program-specific research program for a very small number of transplants is not an effective use of transplant program resources and is not likely to generate sufficient data to provide a meaningful analysis of outcomes beyond individual case reports or limited series. In the two years since the HOPE Act variance was expanded by the OPTN to include all solid organs, only two programs have sought additional approval and only a single heart transplant has been done.
We feel that lack of program participation is a barrier to patient access and limits life-saving transplantation opportunities for a disadvantaged patient group.
As with any policy change, ending the HOPE Act transplant allocation variance and allowing HOPE Act transplants to occur as a component of standard OPTN policy will prompt standard OPTN assessments of the impact of the policy change. The OPTN would continue to monitor HOPE Act transplant activity, outcomes, and safety using the existing OPTN data and safety structures for at least five years. We believe this approach is in the best interests of the patients we serve.
We would also ask that the ACBTSA consider any potential unintended consequences of shifting the NIH-analogous functions for non-kidney and non-liver organs to the OPTN. Assuming this important and multifaceted role, would require additional resources and expertise to be successful. The proposed 15-month timeline would need to be extended to account for all steps in the OPTN policy development and implementation processes. The OPTN Contractor has agreed that data collected pursuant to the OPTN’s regulatory requirements in §121.11 of the OPTN Final Rule will be collected through federal government Office of Management and Budget (OMB) approved data collection forms and therefore subject to its approval process under the Paperwork Reduction Act of 1995. We would welcome further discussions on how to best proceed to effectively and safely expand access to transplant under the HOPE Act.
We appreciate the extraordinary efforts of the ACBTSA in evaluation of these complex questions.
Sincerely,
Jerry McCauley, MD, MPH
President, OPTN Board of Directors
Jeff Berry
Dear Advisory Committee members,
I am writing in support of the draft recommendation that is currently before the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) related to the implementation of the HIV Organ Policy Equity (HOPE) Act of 2013, in support of making HIV-to-HIV transplants standard of care for patients with HIV and end-stage organ disease. Transplanting HIV patients with organs from donors diagnosed with HIV helps free up deceased donor organs for the next person waiting, regardless of HIV status.
I am executive director of The Reunion Project, the national alliance of HIV long-term survivors. Over 50% of people living with HIV (PLHIV) are over the age of 50, and in a few years it will be 70%. While PLHIV are living longer due to the availability of more effective and tolerable treatments, we are experiencing a higher rate of comorbidities, at an earlier age and an accelerated rate. Thus the number of PLHIV requiring organ transplants will only grow larger as the absolute number of this population increases over the next few years.
HIV patients in need of kidney and liver transplants can only currently go to 30 transplant centers out of 250. I personally knew at least one person who died because they were being required to travel across the country because the center near them wasn't doing HOPE transplants. Making them standard of care will benefit and increase HIV-to-HIV transplant implementation, and thus benefit everyone waiting on an organ transplant, living with HIV or not.
Sincerely,
Jeff Berry
Executive Director
The Reunion Project
American Society of Transplantation
November 8, 2022
Advisory Council on Blood and Tissue Safety Availability
Office of Infectious Disease and HIV/AIDS Policy
U.S. Department of Health & Human Services
300 C Street, S.W.
Suite L 100
Washington, D.C. 20024
RE: Written Public Comment – November 17, 2022, Meeting – HOPE Act
Dear ACBTSA Members:
On behalf of the American Society of Transplantation (AST), representing a majority of medical professionals engaged in the field of solid organ transplantation, thank you for the opportunity to provide comments regarding implementation of the HIV Organ Policy Equity (HOPE) Act of 2013, pertaining to HIV-positive to HIV-positive organ transplantation. The AST is grateful for the ongoing leadership of ACBTSA and the organization’s strong commitment to organ transplantation. Almost a decade ago, AST worked tirelessly with key transplant stakeholder organizations and Congress to advance this important legislation, culminating in the Society’s President, Dr. Dan Solomon, proudly standing alongside President Obama as the HOPE Act was signed into law. AST is committed to the implementation of the HOPE Act and thanks ACBTSA for the opportunity to provide input into this process.
The AST reviewed the recommendation under review before the ACBTSA, with input from our Infectious Disease Community of Practice (IDCOP), and have the following comments:
- We feel that sufficient studies have been performed to support routine use of HIV+ donors without requirement of transplantation under an IRB for HIV+ liver and kidney transplant recipients. The AST is unanimously supportive of removing the regulations surrounding these transplants.
- Given the standard of care practices in place for evaluation for HIV+ heart and lung transplant candidates, the AST believes patients have sufficient scrutiny and clinical monitoring regardless of donor HIV status. Removing some of the regulations surrounding HIV+ donors should reduce barriers to donation and transplantation, including organ specific HIV transplant experience criteria. AST is also in favor of making data collection in these thoracic transplant cases as simple and straightforward as possible.
- Given the expected small numbers of such transplants, we want to emphasize the importance of ongoing data collection at the national level including variables currently collected by the NIH study. Ideally this data would be collected by the OPTN and include the currently collected fields. Concerns were raised that the OPTN Disease Transmission Advisory Committee (DTAC) may not be the best poised to collect this information. The AST IDCOP’s HIV Work Group members are happy to assist the ACBTSA in choosing variables as the data collection tool is developed. Adapting the data collection tool to support innovation is critical to advancing the field.
Again, thank you for this opportunity. Please do not hesitate to contact me directly if you have questions or require any additional information. Additionally, the AST Director of Government Relations, Bill Applegate, may be reached at [REDACTED].
Sincerely,
Deepali Kumar, MD, MSc, FRCPC, FAST
President
American Society of Transplantation
National Alliance of State and Territorial AIDS Directors (NASTAD)
November 9, 2022
Advisory Committee on Blood and Tissue Safety and Availability
Department of Health and Human Services
Tower Building, 1101 Wootton Parkway
Rockville, MD 20852
RE: HIV Organ Policy Equity Act Comments on Implementation
On behalf of NASTAD, a leading non-partisan non-profit association that represents public health officials who administer HIV and hepatitis programs in the U.S., I am writing to provide comments on the implementation of the HIV Organ Policy Equity (HOPE) Act of 2013.
At the federal level, the HOPE Act sought to support “research criteria relating to transplantation of HIV positive organs into HIV positive individuals” when the law was enacted back in 2013. The policy went into effect in November 2015. As of 2020, 223 transplants from individuals who identified as HIV-positive to people living with HIV were performed.
Since 2015, 21 states and the District of Columbia have adopted the legislation. Additionally, 36 hospitals and organ transplant centers that were approved through current Institutional Review Boards (IRB) processes established by the U.S. Department of Health and Human Services (HHS) are conducting organ transplantation for people living with HIV (PLWH).
NASTAD believes that further and more expedited implementation of the HOPE Act at the federal level is necessary to remove the remaining barriers that exist to HIV organ transplants for people living with HIV.
People living with HIV face a spectrum of stigma, including laws that actively work against their HIV diagnosis status, including HIV criminalization laws at the state level. PLWH may fear organ donor registers based on a lack of information around the legality of donating organs and stigma for members in the LGBTQ+ community in healthcare. Organ procurement and donation centers may also lack necessary education on HIV organ transplantation and community outreach for PLWH.
The drafted recommendations for the fifty-sixth Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) meeting represent an important step forward, including removing statuary “NIH Research Criteria and IRB” requirements for liver and kidney transplants.
Clinical research demonstrated the efficacy of certain organ transplants from identified HIV-positive individuals to PLWH since 2015. Furthermore, organ transplants that are still considered under “NIH Research Criteria and IRB” requirements in the recommendations should have a threshold of efficacy to remove the statuary requirement or a timeline to demonstrate efficacy from existing or new centers. These recommendations have the potential to broaden access to safe and life-saving organs for PLWH.
However, the recommendations do not go far enough to provide state level implementation that creates the healthcare infrastructure to provide more readily accessible organ donations and transplants for PLWH. Additionally, the states where centers and hospitals are performing transplants only capture a fraction of the populations in the Ending the Epidemic (EHE) initiative. Furthermore, there is disparate access to a variety of solid organ transplants across the different states.
Aging populations are more likely to need necessary life-saving organ transplants. Currently, over half of adults living with HIV are over the age of 50, and by 2030 over 70 percent of PLWH in the United States will be over 50. With an aging population of PLWH – who often face unique health challenges – there is a heightened need to leverage organ transplant and donation systems and policies.
NASTAD supports pragmatic efforts to ensure the holistic health of PLWH across the United States, especially with living saving opportunities for organ donations and transplants.
Sincerely,
Stephen Lee MD, MBA, DHSM
Executive Director
NASTAD
Komal Kumar
I am writing today, November 9, 2022, to comment in support of the draft recommendation put for discussion before the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) related to the implementation of the HIV Organ Policy Equity (HOPE) Act of 2013.
From 2017-2018, I was privileged to serve as a Fulbright Scholar in South Africa under the mentorship of Dr. Elmi Muller (https://en.wikipedia.org/wiki/Elmi_Muller). Prior to my arrival, what I knew of the pioneering procedure was limited to the scarce reports by the media and a handful of publications in the literature. But when Elmi first told me her journey, I knew that there was more to this story that people needed to hear.
14 years ago, a fearless surgeon performed the world’s first transplant of an HIV+ kidney into an HIV+ recipient at Groote Schuur Hospital in South Africa (https://www.theguardian.com/world/2008/oct/25/aids-south-africa-hiv-barnard). Where many in her place would step back, she stepped forward. When institutions built walls around her, she broke them down. When government officials threatened her career, she persevered. At a time of HIV denialism in South Africa, where patients with end-stage renal disease and HIV had no option but to die, she pioneered an established procedure on a stigmatized population.
Dr. Muller's perseverance in pushing this life saving innovative approach forward in the absence of evidence and in the face of resistance is nothing less than commendable. She has laid the foundation for scientific discovery, impacted legislation beyond the borders of her country, and has made a significant contribution towards health equity. With over 150 surgeries in 5 countries and over 100 research citations in her repertoire, the ‘Muller Effect’ has only just begun.
Thus, I have started filming a documentary, In Absence of Evidence, in order to raise awareness of this landmark procedure, promote organ donation among people living with HIV, and most importantly, honor her laudable contribution. I have been uniquely suited to make this film since I have been on both sides of the Atlantic Ocean working with these HIV-to-HIV kidney transplants. Not only have I worked side by side with pioneering transplant teams in both South Africa and the United States and with the organ donation community, I live and thrive at the crossroads of public health and social justice (https://www.inabsenceofevidence.com/).
Reflecting on my experience conducting patient interviews in Baltimore and Cape Town, I recognized how easily research findings could stay enclosed within scientific journals without reaching patients. Research, though progressive and critical, is limited if not described to patients in a language they can understand. I view this documentary as an extension of my research. I chose to create a film as part of the solution to educating and informing people living with HIV that they too can be organ donors.
Since the first HIV-to-HIV kidney transplants were performed in 2008, multiple countries have followed suit, namely Switzerland, US, UK, India, and most recently Denmark. It is due time to consider taking HIV-to-HIV transplants out of research. I thank the ACBTSA for considering this draft recommendation, and I hope you will support it.
American Society of Nephrology
November 9, 2022
Advisory Committee on Blood and Tissue Safety and Availability
Office of Infectious Disease and HIV/AIDS Policy
U.S. Department of Health & Human Services
330 C Street, S.W.
Suite L100
Washington, D.C. 20024
Dear Members of the Advisory Committee on Blood and Tissue Safety and Availability:
On behalf of the more than 37,000,000 Americans living with kidney diseases and the 21,000 nephrologists, scientists, and other kidney health care professionals who are members of the American Society of Nephrology (ASN), thank you for the opportunity to comment on the proposal to the Fifty-Sixth ACBTSA Meeting: November 17, 2022, related to the implementation of the HIV Organ Policy Equity (HOPE) Act of 2013, pertaining to HIV-positive to HIV-positive organ transplantation. ASN is committed to creating a world without kidney diseases, including by continuing to drive improvements in transplantation and ensuring every American who could benefit from a transplant has access to this critical therapy.
ASN advocated vociferously for the passage of the HOPE Act and remains a staunch supporter of the objectives this important legislation, now enshrined in law. As the society wrote at the time the law was enacted in 2013:
“This legislation would end a medically outdated 1980s-era federal ban on the transplantation of organs from deceased HIV+ donors to people with HIV who are on the waitlist. Research shows that lifting this ban could add up to 600 organs per year for HIV-infected transplant candidates. That means patients with HIV could get faster access to a new supply of HIV+ organs—significantly shortening the wait list for individuals without HIV who are currently waiting for a transplant.”
ASN believes a strong and equitable transplant system is essential to meet the needs of the more than 800,000 Americans living with kidney failure. Of the more than 100,000 people currently on the transplant waiting list, there are nearly 90,000 people waiting to receive a kidney, the largest subset of any organ. Devastatingly, the national organ shortage means that 13 people die every day while on the kidney transplant waitlist. While a kidney transplant is the optimal therapy for most people living with kidney failure, transplantation remains out of reach for too many people.
The promise of the HOPE Act remains that patients with HIV could utilize previously-discarded HIV+ organs should they and their care teams so choose—potentially shortening both their wait time to receive a transplant and potentially shortening the wait list for individuals without HIV waiting for a transplant.
Notably, however, the full potential of that promise has yet to be realized. As authors of the editorial “Maximizing HIV Organ Policy Equity for transplant candidates with HIV,” wrote in 2022 “In the first 4 years of the HOPE clinical trials, there were 92 HOPE donors who donated 177 organs (131 kidneys, 46 livers) to recipients with HIV at 24 centers. In more recent years, there have been about 35 donors per year, still falling far short of the numbers predicted by Woods et al” in original their estimates of how bill passage might increase HIV+ organ transplantation to HIV+ recipients. Nonetheless, recent estimates suggest there are indeed likely more available organs from HIV+ donors that meet donation criteria than has been realized in current practice. Notably, line with more than a decade of research and evaluation with other countries where HIV+ organ transplants have been performed for longer, no concerns about the safety and efficacy of this procedure have surfaced since the passage of the HOPE Act in the United States.
Research indicates that institutional-level barriers to establishing IRB-approved studies to perform HIV+ transplants (as currently required) may be limiting the number of transplants that could be provided to interested HIV+ individuals. While there is a need to provide more education to health professionals and to patients about the changes that the HOPE Act made possible, ending the requirement that HIV+ kidney transplantation can only be performed in the context of IRB-approved studies is a timely and important step to realizing the unfulfilled potential represented by the HOPE Act. Accordingly, ASN unequivocally supports the draft recommendation to be discussed at the upcoming November 17 meeting:
“Kidneys and Livers – remove statutory ‘NIH Research Criteria and IRB’ requirement (with no special restrictions other than the applicable Organ Procurement Transplant Network [OPTN] kidney and liver policies).” ASN also supports the timeline for review and re-evaluation of criteria two years after implementation of the recommendations under consideration.
ASN stands ready to assist the Advisory Committee in any way possible to increase patient access to safe transplantation for people living with HIV (PLWH). To discuss these recommendations further, please feel free to contact David White, ASN Regulatory and Quality Officer, at [REDACTED].
Sincerely,
Roslyn B. Mannon, MD, FASN
Chair, ASN Policy and Advocacy Committee
Scott D. Bieber, DO
Chair, ASN Quality Committee
Infectious Diseases Society of America, HIV Medicine Association
November 9, 2022
James Berger
Designated Federal Officer for the ACBTSA
Office of Infectious Disease and HIV/AIDS Policy
Office of the Assistant Secretary for Health
Department of Health and Human Services, Tower Building
1101 Wootton Parkway
Rockville, MD 20852
Submitted via email: ACBTSA@hhs.gov
Dear Mr. Berger:
On behalf of the Infectious Diseases Society of America and its HIV Medicine Association, thank you for the opportunity to comment on the recommendations being considered on November 17 by the Advisory Committee on Blood and Tissue Safety and Availability related to the IRB and NIH Research Criteria requirements associated with the HIV Organ Policy Equity (HOPE) Act of 2013. IDSA is a community of more than 12,000 infectious diseases (ID) physicians and other health care professionals who specialize in infectious diseases. IDSA’s HIVMA represents more than 5,000 physicians and other health care professionals working on the frontlines of the HIV epidemic in communities across the country.
We write in support of the ACBTSA recommending that the Department of Health and Human Services remove the:
- IRB and NIH Research Criteria requirements for liver and kidney HOPE Act transplantations; and
- NIH Research Criteria requirements for non-liver and non-kidney HOPE Act transplantations with the adoption of special policies to be developed by the Organ Procurement and Transplantation Network as outlined in the recommendation.
These important next steps in the implementation of the HOPE Act are appropriate given the recently published multi-site study data providing evidence of the safety and efficacy of liver and kidney HOPE Act transplantations in practice. The removal of the IRB and Research Criteria requirements will help to improve timely access to kidney and liver organ transplantations for people with HIV.
Saving Lives by Reducing Barriers to Transplantation for People with HIV
People with HIV with access to HIV care and treatment can live long and healthy lives. The high rates of kidney and liver disease among people with HIV can now be a greater threat to their quality of life and to their health than HIV. Barriers to accessing and receiving transplantations contribute to the significant impact of kidney and liver disease on people with HIV affected by these conditions. One study found that people with HIV were 32% less likely to be wait listed for kidney and 25% less likely to receive a kidney transplant. For liver transplantation, HIV status has been associated with a 43% risk of mortality while on the wait list and a 41% lower rate of transplantation.
As one of our members noted, with the highly effective treatments available for HIV today “we cannot let people die on an organ waiting list without offering this option.” With only 30 of the 250 transplant centers currently participating in the HOPE Act clinical trials, access to HOPE Act transplantations has been limited for people with HIV not in close proximity to participating centers. Removing the IRB and research requirements will encourage more centers to perform HOPE Act transplantations, and also help to generate more clinical data and experience to inform practice.
Supporting the Next Phase of HOPE Act Implementation
IDSA and HIVMA applaud the HOPE Act investigators for their contributions to science and to improving the lives of people with HIV. We were early and strong proponents of legislation to allow for the study of organ transplantation between HIV positive donors and recipients to advance transplant medicine and in doing so reduce morbidity and mortality due to liver, kidney or other organ disease among people with HIV. We appreciate the important and ongoing work of the HOPE Act researchers and of federal partners at HHS, the National Institutes of Health and the Health Resources and Services Administration Organ Procurement and Transplantation Network to support and fund HOPE Act research and implementation.
To help inform the next phase of HOPE Act transplantations, we highlight the following issues of importance recognizing that this is not a comprehensive list of future considerations and that the issues may not fall under the purview of the ACBTSA:
- In the OPTN guidance, informed consent for a HOPE Act organ donation should be maintained, and people with HIV who forgo a HOPE Act organ donation should maintain the option of receiving an HIV negative organ.
- Physicians with infectious diseases or HIV expertise should be involved in patient vetting and selection as members of the transplant team or through consultation.
- The experience of patients who have received HOPE Act transplants should be translated into future research questions.
Now that clinical trials have demonstrated the safety and efficacy of HOPE Act transplantations, we are optimistic about the potential to save lives by expanding access to organ transplantations for more people with HIV. While additional research will be important, this critical step will save lives and generate more opportunities for further study. We look forward to partnering with HHS, NIH and HRSA on the next phase of HOPE Act implementation. Please contact the HIVMA Executive Director Andrea Weddle at [REDACTED] or the IDSA Director of Public Policy Eli Briggs at [REDACTED] with questions regarding our comments.
Sincerely,
Carlos del Rio, MD, FIDSA
President, IDSA
Michelle Cespedes, MD, MS
Chair, HIVMA
Human Rights Campaign
Submitted via acbtsa@hhs.gov
November 9, 2022
Re: Written Public Comment – November 17, 2022 Meeting
To Whom It May Concern:
On behalf of the Human Rights Campaign’s more than three million members and supporters nationwide, I write in response to the Department of Health and Human Services Advisory Committee on Blood Tissue Safety & Availability (Committee) request for public comments regarding the Committee’s proposal to the implementation of the HIV Organ Policy Equity (HOPE) Act of 2013, pertaining to HIV-positive to HIV-positive organ transplantation published in the Federal Register on October 5, 2022. HIV has a disproportionate impact on the LGBTQ+ community as well as racial and ethnic minorities. HRC is committed to ensuring that those living with HIV continue to receive quality healthcare. As the nation’s largest organization working to achieve equal rights for the lesbian, gay, bisexual, transgender and queer (LGBTQ+) community, we strongly support the proposed recommendations to the HOPE Act implementation, and we thank the Committee for proposing these recommendations.
The HIV Organ Policy Equity Act provided standards to ensure that organs infected with HIV may be transplanted into individuals who were already HIV positive. Those receiving an HIV organ transplant must also participate in clinical research approved by an institutional review board under the criteria, standards, and regulations regarding organs infected with HIV. The HOPE Act was passed with the intention to mitigate the organ shortage by allowing donors with HIV to donate to people with HIV also experiencing end stage organ disease. Initially HHS imposed requirements to limit the use of HIV positive donors to IRB-approved protocols. These requirements were well intentioned and have provided valuable data demonstrating the safety and efficacy of this source of donor organs. However, now there is sufficient data to lift this requirement to allow the HOPE Act to be more effective.
Since the HOPE Act was enacted, transplant clinicians have not observed the large number of organs from donors with HIV that were expected. The original aims of increasing the donor population and increasing donor recipients were not met due to the restrictive requirements imposed by the implementation of the HOPE Act. This has dire consequences because people living with HIV are nearly twice as likely to die while waiting on an organ compared to the standard transplant waitlist candidate who doesn't have HIV. Only 35 transplant centers have protocols in place to perform transplantation between people with HIV. The regulatory impediments related to initiating IRB approved trials as dictated by the HOPE Act prevent many centers from providing transplants using organs with HIV, despite having candidates with HIV on their transplant waiting lists. These factors have created such a high burden that has reversed the equity that the legislation was supposed to provide. It is time to update the recommendations and allow the HOPE Act to effectively serve HIV positive individuals.
The proposed recommendation to remove statutory “NIH Research Criteria and IRB” requirements for kidney and liver transplantations, as well as the recommendation to removing the statutory “NIH Research Criteria” requirement for all other organs while recommending the Secretary direct the OPTN to develop and implement the new special policies, provide important steps in the right direction. These recommendations would honor the original purpose of the HOPE Act of increasing the accessibility of organ transplants. With fewer hurdles, we believe more transplant centers would initiate HIV organ transplants. This would noticeably reduce waiting times for recipients of the HOPE transplants, while also boosting utilization of the insufficient resource of donor organs. Access to organ donations would increase, helping to prevent many HIV positive individuals from dying while waiting for an organ transplant. The proposed recommendation would also be consistent with the most recent and up to date scientific research, as multiple studies continue to demonstrate the safety and efficacy of organ transplants between people with HIV.
The Human Rights Campaign strongly applauds and welcomes the proposed recommendations to the HOPE Act. We appreciate that the proposed recommendations better meet the original purpose of the HOPE Act, create more accessibility and access to HOPE transplants, and reflect the current scientific research regarding HIV positive transplants. Finally, we believe that the proposed recommendations will benefit everyone waiting on an organ transplant, living with HIV or not.
American Society of Transplant Surgeons
November 9, 2022
Dear Members of the Advisory Committee on Blood and Tissue Safety and Availability:
The American Society of Transplant Surgeons (ASTS) is pleased to have the opportunity to comment on the Advisory Committee on Blood and Tissue Availability (ACBTSA) recommendations for revisions in the requirements applicable to HIV+/ HIV+ transplants. ASTS is a medical specialty society representing approximately 1,900 professionals dedicated to excellence in transplantation surgery. Our mission is to advance the art and science of transplant surgery through patient care, research, education, and advocacy.
For kidney and liver transplants, the ACBTSA’s proposal would remove statutory “NIH Research Criteria and IRB” requirements (with no special restrictions other than the applicable OPTN kidney and liver policies). For all other organs including thoracic organs, the ACBTSA’s proposal would remove statutory “NIH Research Criteria” requirements but require the OPTN to develop and implement several new policies intended to ensure the safety and efficacy of these transplants. Among other things, the under the proposal, for organs other than kidneys and livers, the OPTN would be required to establish an organ-specific variance for each organ; implement organ-specific candidate criteria and transplant program requirements analogous (but not “identical”) to the NIH Research Criteria implement additional organ-specific OPTN outcomes monitoring; require each center/institution have an IRB-approved protocol that will include measures of outcomes and safety; and, for multiple organ transplants, require adherence to the guidelines of organs with more conservative policies.
ASTS believes that the ACBTSA’s approach strikes an appropriate balance between the need to maintain the safety of HIV+/HIV+ transplants while expanding the availability of such transplants by reducing bureaucratic obstacles. According to a November 2021 review article, as of July 2021, there have been 300 kidney and 87 liver transplants within HOPE research studies in the USA. Early HIV+ /HIV+ kidney transplant outcomes show excellent patient survival (100%) and graft survival (92%).
Unfortunately, the number of HOPE donors continues to grow annually but remains lower than projections, and the availability of HIV+/HIV+ transplantation remains geographically limited. As of July 2021, 35 transplant centers in 21 states had been approved to perform HIV-to-HIV transplants; 19 of these centers are clustered in the eastern United States, and Region 6 still does not have any HOPE-approved transplant centers.
The potential to increase access to these life-saving procedures is substantial. A 2018 survey of 114 US transplant centers regarding planned practice of HIV+ / HIV+ transplantation indicated that fifty transplant centers (43.8%) were planning to perform such transplants, and one survey found that respondents from transplant centers that had already performed a HOPE transplant were more willing to accept HIV + deceased donor organs, suggesting that willingness to accept HIV + organs will likely increase as more HIV+/ HIV+ transplants are performed. For these reasons, we believe that there is significant potential for increased performance of HIV+/ HIV+ transplants. The removal of the current NIH Research Criteria has the potential to significantly expand the availability of these life-saving transplants, especially in areas of the country where access is currently limited or non-existent.
We thank you for the opportunity to comment on these draft recommendations. If you have any questions, please contact Emily Besser at [REDACTED].
Sincerely,
William Chapman, MD
President, American Society of Transplant Surgeons
National Kidney Foundation
November 9, 2022
James Berger, MS, MT (ASCP), SBB
DFO, Advisory Committee of Blood and Tissue Safety Availability
Office of Infectious Disease and HIV/AIDS Policy
Office of the Assistant Secretary for Health
Department of Health and Human Services
Tower Building
1101 Wootton Parkway
Rockville, MD 20852
Re: Fifty-Sixth ACBTSA Meeting regarding HIV Organ Policy Equity (HOPE) Act of 2013
Dear Mr. Berger:
The National Kidney Foundation (NKF) supports the HOPE Act of 2013 and firmly believes human immunodeficiency virus (HIV)-positive patients deserve access to kidney transplantation. We applaud the Advisory Committee of Blood and Tissue Safety Availability (ACBTSA) for its recommendation to remove the NIH research criteria and IRB requirement for the transplantation of kidneys from HIV-positive donors to HIV-positive recipients. Kidney transplantation provides a significant survival benefit for HIV-positive patients compared to dialysis treatment for end-stage renal disease (ESRD). It is well-known within the healthcare community that HIV is a clinically manageable disease, making HIV-positive organ availability a standard of care for HIV-positive kidney failure patients. This step is imperative to improve the quality of life for this patient population.
With the implementation of this recommendation, we ask ACBTSA to collaborate with the Organ Procurement and Transplantation Network (OPTN) to maximize each opportunity for HIV-positive kidney donation and transplantation by working with the 57 organ procurement organizations (OPO) to ensure that they educate donor hospitals about the HOPE Act of 2013, evaluate referrals for suitability without an automatic rule-out, and make substantial and compassionate efforts to seek authorization for kidney donation. Transplant centers should not use the HIV-positive diagnosis alone to discriminate against potential living donors or deny transplant listing for kidney failure patients with HIV.
We also urge ACBTSA to partner with the Centers for Medicaid and Medicare Services to ensure donor hospitals recognize every opportunity for organ donation for patients with an HIV-positive diagnosis and make referrals to the local OPO for an organ donation evaluation as mandated by the Conditions of Participation set forth by CMS.
Achieving health equity is an organizational priority for NKF. We advocate for strategies and policies that advance social justice and access to transplantation for all, including patients with positive HIV status. Like chronic kidney disease, HIV disproportionately affects populations of color. We are committed to being a voice for all kidney patients and appreciate ACBTSA’s dedication to making HIV-positive organs available for transplant for HIV-positive kidney failure patients.
Thank you for your consideration of this request. If you have questions or need additional information, please contact Morgan Reid, Director of Transplant Policy and Strategy, at [REDACTED].
Sincerely,
Kevin Longino
CEO and Transplant Patient
Sylvia E. Rosas MD, MSCE
President
GLMA: Health Professionals Advancing LGBTQ+ Equality (GLMA)
To whom it may concern,
I am writing on behalf of GLMA: Health Professionals Advancing LGBTQ+ Equality in response to the call for comments in preparation for the November 17th committee meeting to consider a recommendation related to the implementation of the HIV Organ Policy Equity (HOPE) Act of 2013, pertaining to HIV-positive to HIV-positive organ transplantation.
GLMA: Health Professionals Advancing LGBTQ+ Equality (GLMA) is the world largest and oldest association of lesbian, gay, bisexual, transgender, and queer (LGBTQ) and ally healthcare professionals in existence today. Initially established in 1981 as the American Association of Physicians for Human Rights, GLMA's mission is to ensure equality in healthcare for LGBTQ individuals and healthcare professionals. With a membership that includes representatives from all aspects of the healthcare industry—including but not limited to physicians, nurses, behavioral health professionals, advanced practice providers, allied health service professionals, students and trainees—our organization is dedicated to advancing LGBTQ equality and improving the health and well-being of all LGBTQ individuals. Throughout our decades of service to the LGBTQ community and the practice of healthcare, GLMA has strived to be a leader in influencing public policy and advocacy. As the Interim Executive Director of GLMA, I attest that I am authorized to submit comment on behalf of the organization.
GLMA was an original supporter of the HOPE Act and the organization remains committed to policies that increase the pool of available organs for transplant. As such, GLMA supports establishing HIV-to-HIV transplants as a standard of care for patients living with HIV and end-stage organ disease. The need is evident: seventeen people die each day waiting for a suitable organ to become available while the national waiting list for donor organs continues to grow. Increasing the number of suitable organs available will improve the lives of countless individuals, including both those living with HIV and those not living with HIV.
Thank you for your leadership and commitment to ensuring that laws and regulations reflect current medical science in efforts to advance organ donation and, most importantly, save lives.
Signed,
Alex Sheldon
Interim Executive Director
GLMA: Health Professionals Advancing LGBTQ+ Equality
Sarah Kiskadden-Bechtel
As a bioethicist and non-profit leader in end-of-life patient advocacy and education, I am a stalwart proponent of empowering all persons to make healthcare decisions that align with their personal beliefs, in such a way that honors their individual dignity and defends their right to decisional autonomy. Upholding a person’s values in healthcare decision-making, whether in regard to organ donation or a plan for the end of life, is a key component to honoring the dignity of each and every person.
For the past nearly 9 years, people living with HIV have been able to make their end-of-life preferences known through donor registration; however, many diagnosed with HIV do not know this legal right exists. I suspect that this may stem from original 2015 HHS regulations that restricted the performance of HIV-to-HIV transplants to voluntary research. Currently, only 30 transplant centers have necessary approval through the Organ Procurement and Transplantation Network, when there are eight times as many eligible transplant centers in the United States. Most of these are located east of the Mississippi River, leaving a substantial population who are eligible to register for organ donation without the means to have their donations fulfilled.
With these considerations in mind, I write to fully support the draft recommendation, increasing opportunities for organ donation from people living with HIV to other people living with HIV as legally permitted by the HIV Organ Policy Equity Act of 2013. Being HIV-positive does not change the fact that organ donation is a generous and kind final act after death. Those diagnosed with HIV who desire to give the gift of life through donation can and should, with the passage of the currently drafted recommendation, join the rest of the population in knowing their first-person authorization will be honored.
Thank you so much for your consideration.
Sarah Kiskadden-Bechtel, MBe
Program Director, Completed Life Initiative (www.completedlife.org);
Associate Faculty in the Columbia University Masters Program in Bioethics
New York, New York, United States
The RID-HIV Martin Delaney Collaboratory for HIV Cure Research Community Advisory Board
We, the Community Advisory Board for RID-HIV, are writing to comment in support of the draft recommendation put for discussion before the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) related to the implementation of the HIV Organ Policy Equity (HOPE) Act of 2013. The RID-HIV Collaboratory “Reversing Immune Dysfunction for HIV-1 Eradication” is part of the Martin Delaney Collaboratories for HIV Cure Research, the flagship NIH program on HIV cure research. RID-HIV is exploring the underlying basis of immune dysfunction in people living with HIV and the impact it has on HIV persistence and viral control. The Collaboratory will also identify pharmacological methods to enable reversal of this immune dysfunction caused by HIV-1 infection. The role of the Community Advisory Board is to help ensure the research agenda of the collaboratory addresses the needs of people living with HIV.
We know clinical adoption of HIV-to-HIV transplantation provides the means to preserve life for people living with HIV and end-stage organ disease. These transplants also can provide additional scientific understanding of HIV reservoirs, which is a central question in HIV cure research (https://insight.jci.org/articles/view/162968[1]). Every transplant center has the capability to preserve and ship blood and/or tissue collection that occurs during the transplant process to other research centers examining the topic of an HIV cure. There is precedent for this kind of collaboration through the Last Gift tissue donation study (http://lastgift.ucsd.edu). Making HIV-to-HIV transplantation standard of care will benefit and increase implementation of these life-saving procedures, and when someone living with HIV is transplanted and removed from the waitlist, this benefits everyone waiting for an organ transplant, living with HIV or not. Increased and full implementation of the HIV Organ Policy Equity Act of 2013 as standard of care can also lead us closer to an HIV cure.
We thank the ACBTSA for having this meeting to discuss this draft recommendation and lend our support.
Sincerely,
The RID-HIV Martin Delaney Collaboratory for HIV Cure Research Community Advisory Board: Danielle Campbell, Adam Castillejo, Paul Edmonds, Tim Hoeffgen, Andy Kaytes, Michael Louella, Nina Martinez, Michael Meulbroek, Rob Newells, Kevin Packer, Raquelle Paulsen, Bridgette Picous, Tom Villa, Lisa Diane White.
Jeff Taylor, HIV+Aging Research Project-Palm Springs
The HIV+Aging Research Project Palm Springs is writing in support of the draft recommendation before the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) related to the implementation of the HIV Organ Policy Equity (HOPE) Act of 2013. The HIV+Aging Research Project-Palm Springs is a nonprofit community-based research organization dedicated to improving the quality of life of those aging with HIV through research, education of both older PLH as well as HIV providers, and research advocacy.
Clinical adoption of HIV-to-HIV transplantation can save the lives people living with HIV and end-stage organ disease. These transplants also can provide additional scientific understanding of HIV reservoirs, which is a central question in HIV cure research. Transplant centers have the capability to preserve and ship blood and/or tissue from the transplant process to other research centers doing HIV cure research. There is a precedent for this through the Last Gift tissue donation study (http://lastgift.ucsd.edu). Making HIV-to-HIV transplantation standard of care will benefit and increase implementation of these life-saving procedures.
When someone living with HIV is transplanted and removed from the waitlist, this benefits everyone waiting for an organ transplant, living with HIV or not. Increased and full implementation of the HIV Organ Policy Equity Act of 2013 as standard of care can also benefit research toward an HIV cure.
We thank the ACBTSA for having this meeting to discuss this draft recommendation and lend our support.
Sincerely,
Jeff Taylor
HIV+Aging Research Project Palm Springs
Treatment Action Group
Hello ACBTSA Members:
Treatment Action Group (TAG) is submitting this public comment in response to the request for comment to inform ACBTSA’s (hereafter “the Committee”) upcoming November 17, 2022 discussion and voting on the recommendation related to implementation of the HIV Organ Policy Equity (HOPE) Act of 2013, specifically pertaining to HIV-positive to HIV-positive organ transplantation and pertaining to the following draft recommendation under consideration regarding removal of the statutory “NIH Research Criteria and IRB” requirement.
Founded in 1992, TAG is an independent, activist, and community-based research and policy think tank comprised of a team of science-based activists working to expand and accelerate vital research and effective community engagement for an end to the HIV, tuberculosis (TB), and hepatitis C (HCV) pandemics. TAG catalyzes open collective action by affected communities, scientists, and policymakers to ensure that all affected communities — especially communities of color and other marginalized communities — receive life-saving prevention, diagnosis, treatment, care, and information.
In accordance with TAG’s mission of promoting universal and equitable access to opportunities to participate in research and the benefits of products stemming from biomedical research, we were among numerous HIV advocacy and policy organizations that championed repeal of the prior federal ban on transplanting organs from HIV+ donors to benefit HIV+ recipients, and we endorsed passage and adoption into law of the HOPE Act statute (Public Law No: 113-51) — which represented a groundbreaking and long-overdue effort to expand access to organ donations and transplantation for people living with HIV (PLWH). We believe that reducing all barriers to the transplantation of organs
from, between, and to people living with HIV constitutes a commitment to Right to Science — a framework through which it is recognized that “States as duty bearers are obligated to ensure that everyone can share in the benefits of scientific advancement” (https://www.treatmentactiongroup.org/wpcontent/uploads/2022/02/tag_ohchr_submission_resolution_47_17.pdf).
Without a doubt, the ability of PLWH to donate and receive organs from other PLWH represents such a benefit of scientific advancement; and now in 2022, nearly a decade since passage of the HOPE Act, there is no justifiable reason not to maximize federal, state and local investments in expansion of this benefit beyond the statutory “NIH Research Criteria and IRB” requirement through which PLWH are currently able to participate as donors in the HIV-to-HIV organ transplantation process. To maintain the current research designation over PLWH’s participation in the organ donation process only further undermines an already proven effective intervention that to-date far too many people remain unaware is even possible — including PLWH who serve to benefit the most from either knowing that designation as a living and/or deceased organ donor is available or knowing that receipt of an organ donated by another person with HIV is an option in the event they should find themselves diagnosed with end-stage organ disease. As we noted in 2004 regarding the harmful impacts of organ shortages on PLWH: “We must increase educational initiatives on the urgency of the organ shortage in the United States. Conversations about organ donation should become a routine part of health education and medical care…” (https://www.treatmentactiongroup.org/publication/chronic-shortage-of-donor-organs-threatens-peoplewith-hiv-2004). This rings true even today, nearly a decade after initial passage of the HOPE Act. In combination with robust education campaigns and community engagement programs that are geared toward medical providers, people living with HIV and the general population, removal of the research requirement from the HIV-to-HIV organ donation intervention will undeniably allow for more transparent and medically accurate communication between patients, their families and providers regarding their health care options.
Despite a steady increase in the number of kidney and liver transplants performed among PLWH and the fact solid organ transplantation has become the treatment of choice for organ failure among this population, we are dismayed at low awareness of the HOPE Act’s stipulations, persistent challenges in regards to its implementation, and slow expansion of the ability of PLWH who are in need of donated organs to access its benefits. HIV stigma and low donor registration rates pose barriers to expanded awareness and access to benefits of the HOPE Act. So, too, do systemic barriers (e.g., inefficient protocols and suboptimal community engagement activities) and structural barriers (e.g., laws that criminalize organ donation by PLWH). It is imperative that we address systemic and structural barriers in order to ensure more efficient, equitable access to organ donation for PLWH. Removing the research designation over organ transplantations made possible by the HOPE Act has the potential to dramatically further transform the landscape of health equity for PLWH by combating structural HIV stigma, while concomitantly reducing inequities for racial and ethnic minoritized populations who are disproportionately affected by HIV and other chronic illnesses that imperil organ longevity in the first place.
In 2022, it is unacceptable that any person living with HIV who wishes to become a live and/or deceased donor is unaware of their ability to do so. It is also unconscionable for any PLWH who needs to receive an organ donation to be denied this medical intervention due to suboptimal education about their options or due to organ waste resulting from barriers presented by the statutory research designation. As Nina Martinez, an organ transplantation and HIV advocate, and the first PLWH living kidney donor has poignantly noted, also in response to this request for public comment: “All transplant candidates benefit when people living with HIV are transplanted because active HIV-to-HIV transplant programs free up the next available organ from a deceased donor not diagnosed with HIV, which then goes to the next patient waiting for a transplant.”
We firmly agree with her and other advocates that removal of the research requirement will only serve to increase the availability and access to organ transplantation for both PLWH and for individuals who are not living with HIV. Furthermore, we also concur with her that it is absolutely essential to ensure that information about the legality and real-time implementation of the HOPE Act (e.g., the number of successful HIV-to-HIV transplantation procedures) is made available for public consumption on the organdonor.gov website and via as many government-supported organ donation education outlets for patients and providers as possible. Accordingly, we strongly endorse the draft recommendation currently under consideration for voting by ACBTSA as a critical step toward achieving more equitable access to organ donation for PLWH.
