November 17, 2022
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.