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Criteria Published for Research into Organ Transplantation from One Person with HIV to Another

Ronald Valdiserri

Dr. Ronald Valdiserri

Federal partners recently took two important steps that will allow scientists to carry out research on organ donations from HIV-positive donors into HIV-positive recipients as authorized by the HIV Organ Policy Equity (HOPE) Act. As required under the Act, the Organ Procurement and Transplantation Network (OPTN) and the National Institutes of Health (NIH) have each finalized and published safeguards and criteria for research to assess the safety and effectiveness of these transplants.

While the HOPE Act doesn’t currently permit HIV-positive organ transplantation as standard care, it does allow its implementation at research centers with a research protocol approved by their Institutional Review Board. The actions taken by federal partners in November will help guide and make that research possible, eventually providing us with lifesaving information about HIV-positive to HIV-positive organ donation and transplantation.

OPTN and NIH Actions

In the first important step, on November 19 and 21, 2015, OPTN made policy and data system changes to allow the recovery and transplantation of kidneys and livers from HIV-positive donors, with specific patient safety measures intended to assure that these organs are only used for HIV-positive candidates.  (Read more about the OPTN changes.)

The second important step was taken last week by NIH when it published Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected with HIV. The criteria are grouped into six broad categories: Donor Eligibility, Recipient Eligibility, Transplant Hospital Criteria, Organ Procurement Organization Responsibilities, Prevention of Inadvertent Transmission of HIV, and Study Design/Required Outcome Measures. These criteria provide the framework for clinical studies on transplantation of HIV-infected organs to begin in the United States as early as 2016.

The focus of the research criteria is limited to transplants involving livers and kidneys.  This limitation is based on the fact that researchers and clinicians already have a substantial experience base with HIV-negative to HIV-positive transplantation of these organs, which NIH believes is an important prerequisite to the performance of HIV-positive to HIV-positive transplants. The intent of this limited focus is not to exclude the possibility of HIV-positive to HIV-positive transplantation of other organs. However, the experts who developed the criteria believe that organ-specific transplant teams for other organs must first gain experience with HIV-negative to HIV-positive transplantation before embarking on HIV-positive to HIV-positive transplantation. According to the published research criteria, the minimum combined experience required of the transplant physician and HIV physician on the team is five organ-specific cases over four years.

An interagency work group led by NIH’s National Institute of Allergy and Infectious Diseases developed the criteria. The process included input from CDC, HRSA, and NIH’s National Institute of Diabetes and Digestive and Kidney Diseases as well as the transplantation community, and the HIV medical communities.  (Read the related NIAID Bulletin.)

These developments in implementation of the HOPE Act are further strides in responding to National HIV/AIDS Strategy’s call to ensure that the nation’s laws and policies reflect current public health best practices for preventing and treating HIV. They will also, ultimately, help us address the Strategy’s second goal of improving access to care and health outcomes for people living with HIV given that, with effective HIV treatment, individuals are living longer and now experiencing other conditions, including liver failure and end-stage renal disease, which may require organ transplantation.

The HOPE Act

The HOPE Act was signed into law on November 21, 2013, amending the National Organ Transplant Act to remove the prohibition of transplantation of organs procured from HIV-positive donors and to permit transplantation of organs from HIV-positive donors only into recipients who have been previously infected with HIV.  The Act initially limits these transplants to the context of clinical research.  The HOPE Act required that the research criteria and the necessary changes to regulation and OPTN policy be published within two years of its date of enactment (i.e., by November 21, 2015).

The HOPE Act requires that by November 21, 2017, and each year thereafter, the HHS Secretary review the results of scientific research in conjunction with the OPTN to determine whether the results warrant further revision to OPTN policy. Ultimately, if the research demonstrates that transplants from HIV-positive donors to HIV-positive recipients can be done safely, the HHS Secretary would have the authority to direct the OPTN to establish policies to ensure the safety of such transplants outside of a research protocol, which could potentially expand the supply of life-saving organs available for transplantation.