Revisions to Human Immunodeficiency Virus (HIV) Policies to Align with Federal Regulatory Updates

At a glance

Current Policy

The 2013 HIV Organ Policy Equity (HOPE) Act has allowed organ transplantation from donors with HIV (human immunodeficiency virus) to candidates living with HIV. These transplants could only be performed by transplant programs that met and followed research protocol guidelines published by the Department of Health and Human Services (HHS) through the National Institutes of Health (NIH). In 2024, the HHS modified the OPTN Final Rule to remove research requirements for transplantation of kidneys, livers, and liver-kidneys from donors with HIV to candidates living with HIV.

Proposed changes

• Removes variance requirements for kidney, liver, and liver-kidney HIV transplants.
• Adds additional patient safety measures for kidney, liver, and liver-kidney HIV transplants.
• Ensures that policy language consistently and appropriately refers to individuals with HIV.
• Eliminates an exception to HIV screening that may be inconsistent with patient safety goals and unnecessary because of improved organ preservation techniques.
• Clarifies that the OPTN may request data safety monitoring reports from transplant programs participating in the HOPE Act variance.

Anticipated impact

• What it's expected to do
  • Expand organ access to candidates living with HIV.
  • Maintain patient safety for all candidates regardless of HIV status.

• What it won't do
  • Organs from donors with HIV will still only be available to candidates living with HIV.
  • Participation in the HOPE Act variance is still required for programs in order for their non-kidney and non-liver candidates living with HIV to receive offers for organs from donors with HIV.

Terms to know

• HIV: Human immunodeficiency virus. The virus destroys cells in the immune system, which makes it difficult for the body to fight off infections; toxins, or poisons; and diseases. HIV causes AIDS, a late stage of the virus characterized by serious infections, malignancies and neurologic dysfunctions.
• NIAID: National Institute of Allergy and Infections Diseases. Federal agency that conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.
• NIH: National Institutes of Health. The primary federal agency for conducting and supporting medical research.
• Final Rule: A federal regulation that either creates a new regulation or removes or modifies existing federal regulation.
• Research Protocol: A document that establishes the parameters of a scientific study.
• Variance: An OPTN Board-approved, time-limited experimental OPTN policy designed to test a hypothesis that the change will improve allocation by more effectively addressing fairness, utility, efficiency, need and/or supply. A variance must have a research plan that addresses performance measures, data collection and analysis.

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Read the full proposal (PDF)