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HOPE Act Implementation: Words of Caution

In keeping with our recent tradition of inviting guest bloggers to comment on current topics of interest, I have invited Dr. Emily Blumberg to educate us on the implementation of the Hope Act. A recent advocacy success of the AST and other organizations, the HOPE Act permits the use of HIV-positive donor organs in transplantation. Like most things, "the devil is in the details," and the implementation of this new policy will be no different.

Dr. Blumberg is a Professor of Medicine at the Hospital of the University of Pennsylvania and a well-known expert in transplant infectious disease. She has served the AST in many capacities, including a recent term as a Councilor-at-Large on the AST Board of Directors. Her input on this issue is most valuable, and I hope everyone will feel free to add their own perspectives in the comment section.

HOPE Act Implementation: Words of Caution

Emily A. Blumberg, MD, FAST

Prompted by Dr. Elmi Mueller’s groundbreaking experiences in South Africa and supported by a diverse constituency of transplant professionals, HIV providers, and activists, Congress passed the HIV Organ Policy Equity Act (the HOPE Act) on November 12, 2013. This law, passed a year and a half ago, lifted the ban on using organs from HIV-positive donors for transplantation. With the passage of the HOPE Act, researchers began investigating the potential use of these donors in the United States. Studies have focused on determining the nature of the potential donor population: specifically, how many donors might be available, and what the quality of this available donor pool might be.

Researchers have determined that the potential donor pool may be substantial, with estimates ranging from 400 to 2,500 donors annually. What remains unknown is whether these donors are of sufficiently “high quality” to merit procurement. At least some preliminary research suggests that some HIV-positive donors have characteristics that may limit the longevity of the allograft. Regardless, the transplant community seems ready to move forward. Despite the transplant community’s enthusiasm, transplantation with HIV-positive donors has yet to occur. It will likely be a while before any of these donor organs are used.

Why the long delay? In part, this wait reflects the careful thought process of the National Institutes of Health (NIH) as this group works to determine the specific requirements for research. Once the NIH sets these requirements, the Organ Procurement and Transplantation Network (OPTN) will need to develop appropriate policy to safeguard the process. It is important to promote the safety of everyone involved, so careful scrutiny of the process is imperative before transplantation with HIV-positive donors commences. But what stipulations should be set?

Based on early presentations, the NIH appears to be moving towards implementing a more flexible approach, minimizing donor requirements, and potentially even allowing HIV-positive live kidney donors and donors with detectable viral loads. However, I am not sure we should make the initial requirements so flexible. Given the differences between the South African and the United States HIV “epidemics” and availability of dialysis options in the United States, it seems most reasonable to be more cautious with the first donors. For example, HIV-positive live kidney donors may be at increased risk for renal failure themselves. They should be excluded from any initial studies; rational medical judgment should supersede autonomy. Moreover, optimizing the initial donor choice by focusing on those with well-controlled HIV and limited infection and resistance issues (if this information is available) may be more likely to result in better outcomes.

The NIH should consider initially crafting a more cautious donation guideline, then require detailed data collection to best allow us to optimize the use of organs from HIV-positive donors. These organs may be an important addition to the donor pool for at least one segment of those on the wait list. It would be a shame to ultimately destroy the hope of donor pool expansion with HIV-positive donors who necessitate more difficult recipient management.


I want to "second" Dr. Blumberg's comments on the need for caution as the Hope Act is being translated into clinical research and eventually practice. In particular, I strongly support her concerns regarding the use of living donors during the first studies of HIV+ to HIV+ liver and kidney transplantation in the USA. While there likely are family members and friends and perhaps even unrelated donors with HIV who might step forward and offer themselves as potential donors for kidney or liver transplantation, it seems premature to have the initial research protocols include living donors given that we are still trying to learn if the successes in South Africa (where the vast majority of donors with HIV have never been treated with antiretrovirals and thus concerns for acquisition of additional strains of HIV that carry resistance mutations) translate into a similar level of success in the USA where many donors might have been undercare and previously have recieved anti-retroviral treatment. Even for our donors who have personally never been under treatment, their sources of HIV may have. Thus, it remains important to do the clinical research studies in the USA to determine the outcome of HIV+ to HIV+ donation in the USA. Pending these results, it would seem unwise to support research protocols where this might occur. The tentative NIH proposals for what an IRB approved protocol should look like will be released soon and will be subject to public comment as most Federal Initiatives and guidances are. I urge my fellow AST members to provide their comments-especially on key issues like allowing the using of living donors. Michael Green, MD, MPH Professor of Pediatrics, Surgery and Clinical & Translational Science University of Pittsburgh School of Medicine

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