January 10, 2023
ADM Rachel L. Levine, MD
Assistant Secretary for Health
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
RE: Recommendations of the Advisory Committee on Blood and Tissue Safety and Availability
Dear Admiral Levine:
The Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) met on November 17, 2022 to hear updates on the implementation of P.L. 113-51, the Human Immunodeficiency Virus Organ Policy Equity (HOPE) Act of 2013, which provided for HIV-positive to HIV-positive organ transplantation in research settings approved by an institutional review board (IRB) under criteria delineated by the National Institutes of Health as they relate to the Public Health Service Act (45 CFR 46). Specifically, the HOPE Act called for the development and publication of research criteria relating to transplantation of HIV-positive organs into HIV-positive individuals, which was published by the National Institutes of Health in 2015.
Significant work under the auspices of the HOPE Act has resulted in particular success with kidney and liver transplants and no significant safety concerns. According to subject matter experts and based on the collected data, there is excellent patient and graft survival and no signal of increased HIV-related complications such as superinfection or opportunistic infection. As you well know, due to this success, on October 29, 2021, the Organ Procurement and Transplantation Network (OPTN) wrote a letter to Secretary of Health and Human Services Xavier Becerra recommending the removal of the research requirement for organ transplants from HIV-positive organ donors to HIV-positive transplant recipients as prescribed by the HOPE Act.
The ACBTSA subsequently formed HOPE Act Working Group which brought together stakeholders from the organ transplantation, HIV medicine, and infectious disease communities to review the current policy and to make recommendations on the expansion of the HOPE Act. The Working Group developed revised recommendations on the transplantation of other organs for ACBTSA to consider. Given the limited number of HIV-positive to HIV-positive organ transplants other than kidneys and livers, the Working Group felt as though additional research is needed and that these organ transplants should remain under a research protocol and that additional steps should be in place to ensure safety.
The recommendation pertaining to HIV positive to HIV positive organ transplantation adopted by the ACBTSA is as follows:
For the transplantation of organs from HIV-positive donors into HIV-positive recipients
Kidneys and Livers – remove statutory “NIH Research Criteria and IRB” requirement (with no special restrictions other than the applicable OPTN kidney and liver policies).
All other organs, including thoracic organs, – remove statutory “NIH Research Criteria” requirement BUT recommend the Secretary direct the OPTN to develop and implement the following new special policies:
- 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
The OPTN should develop and implement the above-listed new special policies within 15 months of receiving this request from the Secretary of Health and Human Services.
These criteria will be reviewed and re-evaluated 2 years after implementation.
Eleven members of the ACBTSA voted to approve this recommendation. Following ACBTSA consideration, the Blood, Organ, and Tissue Senior Executive Council (BOTSEC), met to deliberate the recommendations. I was pleased to see that the BOTSEC approved the ACBTSA’s HOPE Act recommendation at its meeting on December 15, 2022.
As you are aware, this recommendation will now need the approval of Secretary Becerra before it can be formally implemented. I appreciate your leadership on this issue and am standing by should you need any assistance in your presentation of this proposed recommendation to the Secretary.
Please let me or Mr. Jim Berger, Designated Federal Officer of the ACBTSA, know if you have any follow up questions for the committee or if you would like to meet to discuss these recommendations.
Claudia Cohn, MD, PhD
HHS Advisory Committee for Blood and Tissue Safety and Availability
CC: Mr. Jim Berger, Designated Federal Officer of the ACBTSA