Request for Information: Regarding a Revision to U.S. Public Health Service Guideline: Assessing Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection

Issuing agencies

Abstract

The Office of the Assistant Secretary for Health in the Department of Health and Human Services (HHS) seeks public comment regarding a proposed revision to the 2020 PHS Guideline Assessing Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection (1). The Organ Procurement and Transplantation Network (OPTN) implemented a policy change related to organ transplant candidate assessment and testing on March 1, 2021, to align OPTN policy with the new Guideline recommendations (2). Previous PHS Guideline recommendations did not include a specific timeframe during which pre- transplant testing for HIV, HBV, and HCV infections among organ transplant candidates should occur. In order to more accurately assess pre-transplant infection status and to enable the investigation of possible solid organ donor transmission of infection, the 2020 Guideline specified that pre-transplant HIV, HBV, and HCV testing of transplant candidates should occur during hospital admission for transplant surgery but prior to the implantation of the organ. In May 2021, HHS reviewed communications from members of the public to the OPTN, outlining concerns that the additional amount of blood drawn for infectious disease testing (when added to the relatively large amount of blood required for immediate preoperative laboratory testing) during the admission for transplantation poses potential risks for some pediatric organ transplant candidates. Potential risks due to blood volume loss include those related to preoperative low body weight (and low blood volume), anemia, or exacerbation of underlying co-morbid conditions. HHS conducted a review of the most recent HIV, HBV, and HCV surveillance data in the United States as stratified by age group. Additionally, HHS engaged with relevant stakeholders during May- November 2021, to understand implications of policy changes on organ transplantation and organ utilization. In December 2021, findings from these analyses were presented to the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). The committee considered whether a revision to the Guideline recommendation pertaining to pre- transplant testing of candidates <=10 years of age is warranted. Based on feedback from the ACBTSA and analyses specified above, HHS is proposing changes pertinent to the timing of pre-transplant testing for candidates <=10 years of age. HHS is asking respondents to review the proposed revision to the current Guideline (listed in the Supplementary Information section of this notice) and provide assessments on updating the Guideline, whether this change is achievable in the clinical setting, or if there are potential barriers to implementation. In addition, impact on organ allocation and utilization should be considered. Other comments pertinent to this proposed revision are welcome.