In a Federal Register notice on Nov. 25, 2015, the U.S. Department of Health and Human Services published safeguards and criteria for research to assess the safety and effectiveness of solid organ transplantation from donors with HIV infection to recipients with HIV infection. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), led the development of the criteria, which provide the framework for clinical studies on transplantation of HIV-infected organs to begin in the United States as early as 2016.
The HIV Organ Policy Equity (HOPE) Act, signed into law on Nov. 21, 2013, allows scientists to carry out research into organ donations from one person with HIV infection to another and mandates development of safeguards and criteria for the conduct of such research. Prior to passage of this law, transplantation of organs from people with HIV infection was illegal in the United States.
Thanks to scientific advances that led to effective antiretroviral therapy for treating HIV infection, many people living with HIV have near-normal lifespans. However, people living with HIV are at risk for developing end-stage liver and kidney disease and, like people without HIV infection, can benefit from organ transplantation. In this regard, results from an NIAID-funded study of 275 people with HIV who received a kidney or liver from an uninfected donor showed that outcomes and survival rates were similar to those of transplant recipients without HIV.
The use of organs from donors with HIV infection for transplantation into recipients with HIV infection would increase the number of organs available for everyone on the transplant waiting list. However, little information about the outcome of using organs from people with HIV is available, and the HOPE Act stipulates that organ transplantation from one person with HIV infection to another must be conducted under a clinical research protocol. The safeguards and research criteria aim to ensure that such research is conducted safely and will provide a basis for evaluating the safety and effectiveness of organ transplantation between people with HIV infection. The criteria cover six broad categories: donor eligibility; recipient eligibility; transplant hospital criteria; organ procurement organization responsibilities; prevention of inadvertent transmission of HIV; and required outcome measures.
The safeguards and criteria were developed by representatives from NIAID, the NIH National Institute of Diabetes and Digestive and Kidney Diseases and the Centers for Disease Control and Prevention, with input from other federal agencies, transplantation experts and HIV medical professionals. Draft criteria published in the Federal Register on June 18, 2015, were open for public comment for 60 days. The final criteria reflect comments received from 13 individuals and organizations.
Publication of the HOPE Act research criteria opens the door for researchers to apply for institutional review board approval for clinical research protocols to assess transplantation of HIV-infected organs into recipients with HIV infection. Results of this research will be evaluated to determine whether and how national Organ Procurement and Transplantation Network standards for organ transplantation could be revised to address organ donors with HIV infection.