2024-31265. Final Revised Human Immunodeficiency Virus (HIV) Organ Policy Equity Act Safeguards and Research Criteria for Transplantation of Organs From Donors With HIV

AIDS	Acquired Immunodeficiency Syndrome.
ART	Antiretroviral Therapy.
CD4	Cluster of differentiation 4.
D−	Donor Human Immunodeficiency Virus negative.
D+	Donor Human Immunodeficiency Virus positive.
HBV	Hepatitis B virus.
HCT/Ps	Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).
HCV	Hepatitis C virus.
HIV	Human Immunodeficiency Virus.
HIV-	Human Immunodeficiency Virus negative (using serology and/or nucleic acid testing using FDA-licensed, approved or cleared devices).
HIV+	Human Immunodeficiency Virus positive (using serology and/or nucleic acid testing using FDA-licensed, approved or cleared devices).
HOPE Act	HIV Organ Policy Equity Act.
HRSA	Health Resources and Services Administration.
IRB	Institutional review board.
NIH	National Institutes of Health.
NPRM	Notice of proposed rule making.
OI	Opportunistic infection.
OPO	Organ procurement organization.
PML	Progressive multifocal leukoencephalopathy.
R−	Recipient HIV negative.
R+	Recipient HIV positive.
RNA	Ribonucleic acid.
SOPs	Standard operating procedures.

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Definitions

Antiretroviral therapy (ART) resistance	When an HIV strain develops drug resistance and/or genetic mutations associated with drug resistance.
HIV superinfection	Systemic HIV superinfection is defined as the detection of HIV viral sequences that phylogenetically cluster with the donor's viral population at two or more time points in circulating blood cells, plasma, or recipient tissues other than the allograft.
Suppressed viral load	HIV RNA below 50 copies per mL with current technology at time of publication of this research criteria document.

The NIH Research Criteria are set forth in six broad categories (Donor Eligibility, Recipient Eligibility, Transplant Hospital Criteria, Organ Procurement Organization (OPO) Responsibilities, Prevention of Inadvertent Transmission of HIV, and Study Design/Required Data Elements and Outcome Measures). Table 1 summarizes the Final Revised HOPE Act Research Criteria in each category and compares them to the 2015 Research Criteria.

Table 1—Final Revised Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs From Donors With HIV ¹

Category	Previous criteria	Revised criteria [No longer pertains to kidney and liver transplants 1 ]
Donor Eligibility:
All deceased donors with HIV	No evidence of invasive opportunistic complications of HIV infection	No evidence of invasive opportunistic complications of HIV infection.
	Pre-implant donor organ biopsy	There is no requirement for a pre-implantation biopsy.*
	Viral load: no requirement	Viral load: no requirement.
Deceased donor with known history of HIV and prior antiretroviral therapy (ART)	The study team must describe the anticipated post-transplant antiretroviral regimen(s) to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable, and effective	The study team must describe the anticipated post-transplant antiretroviral regimen(s) to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable, and effective.
Living donor with HIV	Well-controlled HIV infection defined as: • Cluster of Differentiation 4 (CD4) + T-cell count ≥500/µL for the 6-month period before donation • HIV-1 ribonucleic acid (RNA) <50 copies/mL • No evidence of invasive opportunistic complications of HIV infection Pre-implant donor organ biopsy.	Thoracic Organs Exception: The living donor standards are not relevant for thoracic organ transplant except in the rare instances of living donor lung transplant or “domino” heart transplant. In such circumstances, the deceased donor eligibility criteria should be followed. Other Organs: If a living donor with HIV donates another type or organ (other than kidney and liver), the deceased donor eligibility criteria should be followed.*
Recipient Eligibility	CD4+ T-cell count ≥200/µL (kidney) CD4+ T-cell count ≥100 µL (liver) within 16 weeks prior to transplant and no history of opportunistic infection (OI); or ≥200 µL if history of OI is present.	CD4+ T-cell count: no minimum threshold when all other recipient eligibility criteria are met.*
	HIV-1 RNA <50 copies/mL and on a stable antiretroviral regimen	HIV-1 RNA <50 copies/mL and on a stable antiretroviral regimen.
	No evidence of active opportunistic complications of HIV infection	No evidence of active opportunistic complications of HIV infection.
	No history of primary central nervous system (CNS) lymphoma or progressive multifocal leukoencephalopathy (PML)	No history of primary central nervous system (CNS) lymphoma or progressive multifocal leukoencephalopathy (PML).
Transplant Hospital Criteria	Transplant hospital with established program for care of subjects with HIV	Transplant hospital with established program for care of patients with HIV.
	HIV program expertise on the transplant team	HIV program expertise on the transplant team.
	Organ-specific experience with transplants of organs from donors without HIV to recipients with HIV (5 D−/R+ transplant cases over 4 years)	There is no longer a center specific case experience requirement with transplants of organs from donors without HIV to recipients with HIV.* Transplant patients with organs from donors with HIV must be managed with a multidisciplinary team before, during, and after transplant. The multidisciplinary team must include transplant surgeons, physicians, HIV specialists, nurses, social workers, and pharmacists capable of therapeutic drug monitoring to minimize drug-drug interactions.
	Standard operating procedures (SOPs) and training for the organ procurement, implanting/operative, and postoperative care teams for handling subjects with HIV, and organs and tissues from individuals with HIV	Standard operating procedures (SOPs) and training for the organ procurement, implanting/operative, and postoperative care teams for handling HIV-infected subjects with HIV, and organs and tissues from individuals with HIV.
	IRB-approved research protocol for transplantation of organs from donors with HIV in recipients with HIV	IRB-approved research protocol for transplantation of organs from donors with HIV in recipients with HIV for the applicable organs.*
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	Institutional biohazard plan outlining measures to prevent and manage inadvertent exposure to and/or transmission of HIV	Institutional biohazard plan outlining measures to prevent and manage inadvertent exposure to and/or transmission of HIV.
	Provide each living donor with HIV and recipient with HIV with an “independent advocate”	There is no longer a requirement to provide an HIV independent advocate beyond standard site practices.*
	Policies and SOPs governing the necessary knowledge, experience, skills, and training for independent advocates	Policies and SOPs governing the necessary knowledge, experience, skills, and training for independent advocates.
OPO Responsibilities	SOPs and staff training procedures for working with deceased donors with HIV and their families in pertinent history taking; medical chart abstraction; the consent process; and handling blood, tissues, organs, and biospecimens	SOPs and staff training procedures for working with deceased donors with HIV and their families in pertinent history taking; medical chart abstraction; the consent process; and handling blood, tissues, organs, and biospecimens.
	Biohazard plan to prevent and manage HIV exposure and/or transmission	Biohazard plan to prevent and manage HIV exposure and/or transmission.
Prevention of Inadvertent Transmission of HIV	Each participating Transplant Program and OPO shall develop an institutional biohazard plan for handling organs from HIV-positive donors that is designed to prevent and/or manage inadvertent transmission or exposure to HIV	Each participating Transplant Program and OPO shall develop an institutional biohazard plan for handling organs from HIV-positive donors that is designed to prevent and/or manage inadvertent transmission or exposure to HIV.
	Procedures must be in place to ensure that human cells, tissues, and cellular and tissue-based products (HCT/Ps) are not recovered from donors with HIV for implantation, transplantation, infusion, or transfer into a human recipient; however, HCT/Ps from a donor determined to be ineligible may be made available for nonclinical purposes	Procedures must be in place to ensure that human cells, tissues, and cellular and tissue-based products (HCT/Ps) are not recovered from donors with HIV for implantation, transplantation, infusion, or transfer into a human recipient; however, HCT/Ps from a donor determined to be ineligible may be made available for nonclinical purposes.
Required Data Elements and Outcome Measures **
Wait List Candidates	HIV status	HIV status.
	CD4+ T-cell counts	CD4+ T-cell counts.
	Co-infection (hepatitis C virus [HCV], hepatitis B virus [HBV])	Co-infection: • Hepatitis C (HCV RNA). • Hepatitis B (HBV deoxyribonucleic acid, HBV antibody). • Cytomegalovirus (CMV immunoglobulin G [IgG]).*
	HIV viral load	HIV viral load.
	ART resistance	ART resistance.
	Removal from wait list (death or other reason)	Removal from wait list (death or other reason).
	Time on wait list	Time on wait list. Renal dysfunction.* Liver dysfunction.*
		Indication for transplant.* Use of mechanical circulatory devices.* Use of extracorporeal membrane oxygenation, intra-aortic balloon pump, ventricular assist device.*
Donors (all)	Type (Living or deceased)	Type Donation after Brain Death vs. Donation after Circulatory Death vs. Living Donor.*
	HIV status (new diagnosis of HIV, or known diagnosis of HIV)	HIV status (new diagnosis of HIV, or known diagnosis of HIV).
	CD4+ T-cell count	CD4+ T-cell count.
	Co-infection (HCV, HBV)	Co-infection (HCV, HBV).
	HIV viral load	HIV viral load.
	ART resistance	ART resistance.
		Ex-vivo perfusion.*
		• Duration.
		• Warm and cold ischemia time.
		Normothermic regional perfusion.*
		• Duration.
		• Warm and cold ischemia time.
Living Donors	Progression to renal insufficiency in kidney donors	These data elements no longer apply since kidney or liver donation from a living donor with HIV no longer falls under the Research Criteria except that these data elements apply to simultaneous multiple organ transplants.
	Progression to hepatic insufficiency in liver donors.
	Change in ART regimen as a result of organ dysfunction	Change in ART regimen as a result of organ dysfunction.
	Progression to acquired immunodeficiency syndrome (AIDS)	Progression to AIDS.
	Failure to suppress viral replication (persistent HIV viremia)	Failure to suppress viral replication (persistent HIV viremia).
	Death	Death.
Transplant Recipients	Rejection rate (annual up to 5 years)	Rejection rate (annual through 5 years).
	Progression to AIDS	Progression to AIDS.
	New OI	New OI.
	Failure to suppress viral replication (persistent HIV viremia)	Failure to suppress viral replication (persistent HIV viremia).
	HIV-associated organ failure	HIV-associated organ failure.
	Malignancy	Malignancy.
	Graft failure	Graft failure.
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	Mismatched ART resistance versus donor	Mismatched ART resistance versus donor.
	Death	Death.
		Type of rejection (antibody mediated versus cellular rejection).*
		Chronic heart allograft vasculopathy.*
		Chronic lung allograft dysfunction.*
		Hospitalized infections.*
		Estimated glomerular filtration rate.*
		HIV superinfection.*
		Re-transplantation.*
		Simultaneous multiple organ transplants.
* Denotes a revision of the 2015 Research Criteria.
** The previous category of outcome measures (from the original 2015 Research Criteria) is modified to also include data elements.