Notice2022-02389
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
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Published
February 4, 2022
Issuing agencies
Health and Human Services Department
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.
Full Text
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<title>Federal Register, Volume 87 Issue 24 (Friday, February 4, 2022)</title>
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[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Notices]
[Pages 6611-6613]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-02389]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Request for information.
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SUMMARY: 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
[[Page 6612]]
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.
DATES: To be assured consideration, comments must be received at the
address provided below no later than 5:00 p.m. ET on March 7, 2022.
ADDRESSES: Electronic responses are strongly preferred and may be
addressed to <a href="/cdn-cgi/l/email-protection#b6f7f5f4e2e5f7f6dedec598d1d9c0"><span class="__cf_email__" data-cfemail="d392909187809293bbbba0fdb4bca5">[email protected]</span></a>. Please include in the subject line of the
email: ACBTSA-RFI.
FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Designated Federal
Official, Office of Infectious Disease and HIV/AIDS Policy, 202-795-
7608.
SUPPLEMENTARY INFORMATION: Background: Since the emergence of the human
immunodeficiency virus (HIV) epidemic in the 1980s, the U.S. Public
Health Service (PHS) has made recommendations to reduce the risk of HIV
transmission associated with organ transplantation (3, 4).
Historically, recommendations included identifying risk factors among
organ donors associated with HIV infection to minimize risk of
potential transmission to recipients. Recommendations also included
laboratory screening of donors using anti-HIV antibody testing, with
additional testing recommendations added as technologies such as
nucleic acid testing (NAT) were developed. In 2013, based on donor-
derived transmission events and reports of poor recipient outcomes from
hepatitis B virus (HBV) and hepatitis C virus (HCV) transmission, the
PHS released a revised guideline. The 2013 Guideline added organ donor
screening recommendations for HBV (hepatitis B surface antigen [HBsAg]
and total antibody to hepatitis B core antigen [total anti-HBc]) and
HCV (antibody to hepatitis C [anti-HCV] and HCV RNA by NAT), in
addition to HIV, to reduce the risk of unintended transmission through
transplantation (5). This revised Guideline was enhanced by
recommending specific recipient informed consent and post-transplant
recipient monitoring for evidence of possible disease transmission.
In 2020, the Guideline was updated to reflect changes in the
epidemiology of HIV, HBV, and HCV infections, advances in testing, and
the widespread availability of highly effective (for HIV and HBV) and
curative (for HCV) treatment. In addition to several other updated
recommendations, the 2020 Guideline specified that all transplant
candidates should be tested prior to surgery for HIV, HBV, and HCV
infections, with testing to occur during hospital admission for
transplant but before transplantation (1). This recommendation was
implemented in order to more accurately assess pre-transplant infection
status and to enable the investigation of whether infectious disease
transmission may have occurred through transplantation. Based on the
feedback from members of the public that this requirement for repeat
screening at the time of transplantation might pose potential harm to
some pediatric patients due to blood volume loss, HHS (including CDC
and HRSA) conducted additional analyses of surveillance data.
Additionally, CDC and HRSA also participated in a work group convened
by the OPTN and which included members of the OPTN Disease Transmission
Advisory Committee and Pediatric Committee.
CDC surveillance data for the years 2015-2019 pertaining to
incident HIV infections among pediatric populations in the United
States were reviewed. Briefly, 524 children <13 years of age in the
United States and 6 U.S. territories and freely associated states
received a new diagnosis of HIV infection from 2015-2019. Overall, 181
(35%) of these 524 children received their diagnosis of HIV infection
between 0-5 months of age; an additional 23 (4%) were diagnosed between
6-11 months of age. With effective perinatal elimination efforts,
prevalence and incidence of HIV infection in children <13 years of age
in the United States have been steadily decreasing (6). Children <13
years of age are among the lowest risk group for new HIV infections in
the United States. Estimated prevalence of HIV infection in children
<13 years of age in the United States is <2,000; incidence in this age
group is <100 cases per year, and most of these are perinatally
acquired (6). With perinatal testing and clinical follow-up of exposed
children, it is unlikely that a transplant candidate <=10 years of age
would have an undiagnosed HIV infection at the time of organ
transplantation.
CDC surveillance data for 2019 pertaining to incident HBV and HCV
infections among pediatric populations in the United States were also
reviewed. Incident HBV and HCV infections are similarly low among
children in the United States. The rate of acute HBV infection in
persons <20 years in the United States was 0.0 per 100,000 population
as of 2019 (7). Additionally, more than 90% of 2-year-olds and
adolescents in the United States have been vaccinated against HBV (8,
9). The rate of acute HCV infection in persons <20 years in the United
States was 0.1 per 100,000 population as of 2019 (7). Perinatal
exposure is the most common mode of transmission for HCV infection in
children.
In December 2021, HHS convened the Advisory Committee on Blood and
Tissue Safety and Availability (ACBTSA) to receive expert input on
whether, and if so, how, the current PHS Guideline recommendation
pertaining to pre-transplant testing of pediatric candidates should be
revised (<a href="https://www.hhs.gov/oidp/advisory-committee/blood-tissue-safety-availability/meetings/2021-12-01/index.html">https://www.hhs.gov/oidp/advisory-committee/blood-tissue-safety-availability/meetings/2021-12-01/index.html</a>). Additionally, HHS
solicited input from this committee on the specific question as to
whether available data support exempting solid organ transplant
candidates who are <=10 years of age at the time of transplant (and who
have received postnatal infectious disease testing) from the
recommendation for HIV, HBV, and HCV testing during hospital admission
[[Page 6613]]
for transplant but prior to anastomosis of the first organ. The
committee voted unanimously in favor of the change.
Potential revision to the 2020 Guideline: HHS has reviewed the
ACBTSA recommendations and other available information and is
considering the following revision to current recommendations in the
2020 Guideline.
Exempt solid organ transplant candidates who are <=10 years of age
at the time of transplant (and who have received postnatal infectious
disease testing) from the recommendation for HIV, hepatitis B virus,
and hepatitis C virus testing during the hospital admission for
transplant but prior to anastomosis of the first organ.
HHS is not considering changes to any other 2020 Guideline
recommendations. We seek informed feedback regarding this proposed
change to the recommendations in the 2020 Guideline.
Dated: January 25, 2022.
James J. Berger,
Designated Federal Officer, Advisory Committee on Blood and Tissue
Safety and Availability, Office of Infectious Disease and HIV/AIDS
Policy.
Footnotes
1. Jones JM, Kracalik I, Levi ME, et al. Assessing Solid Organ Donors
and Monitoring Transplant Recipients for Human Immunodeficiency Virus,
Hepatitis B Virus, and Hepatitis C Virus Infection--U.S. Public Health
Service Guideline, 2020. MMWR Recomm Rep 2020;69(No. RR-4):1-16. DOI:
<a href="http://dx.doi.org/10.15585/mmwr.rr6904a1">http://dx.doi.org/10.15585/mmwr.rr6904a1</a>.
2. OPTN Policy 15.2: Candidate Pre-Transplant Infectious Disease
Reporting and Testing Requirements. Available: <a href="https://optn.transplant.hrsa.gov/media/eavh5bf3/optn-policies-effective-as-of-dec-6-2021-e-signature.pdf">https://optn.transplant.hrsa.gov/media/eavh5bf3/optn-policies-effective-as-of-dec-6-2021-e-signature.pdf</a>.
3. CDC. Guidelines for preventing transmission of human
immunodeficiency virus through transplantation of human tissue and
organs. Centers for Disease Control and Prevention. MMWR
Recommendations and reports: Morbidity and mortality weekly report
Recommendations and reports/Centers for Disease Control. 1994;43(RR-
8):1-17.
4. CDC. Testing donors of organs, tissues, and semen for antibody to
human T-lymphotropic virus type III/lymphadenopathy-associated virus.
MMWR Morbidity and mortality weekly report. 1985;34(20):294.
5. Seem DL, Lee I, Umscheid CA, Kuehnert MJ. PHS guideline for reducing
human immunodeficiency virus, hepatitis B virus, and hepatitis C virus
transmission through organ transplantation. Public health reports
(Washington, DC: 1974). 2013;128(4):247-343.
6. Centers for Disease Control and Prevention. HIV Surveillance Report,
2019; vol.32. <a href="http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html">http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html</a>. Published May 2021.
7. Centers for Disease Control and Prevention. 2019 Viral Hepatitis
Surveillance Report. <a href="https://www.cdc.gov/hepatitis/statistics/SurveillanceRpts.htm">https://www.cdc.gov/hepatitis/statistics/SurveillanceRpts.htm</a>. Published July 2021.
8. FastStats--Immunization (<a href="http://cdc.gov">cdc.gov</a>): <a href="https://www.cdc.gov/nchs/fastats/immunize.htm">https://www.cdc.gov/nchs/fastats/immunize.htm</a>.
9. Elam-Evans LD, Yankey D, Singleton JA, et al. National, Regional,
State, and Selected Local Area Vaccination Coverage Among Adolescents
Aged 13-17 Years--United States, 2019. MMWR Morb Mortal Wkly Rep
2020;69:1109-1116. DOI: <a href="http://dx.doi.org/10.15585/mmwr.mm6933a1">http://dx.doi.org/10.15585/mmwr.mm6933a1</a>.
[FR Doc. 2022-02389 Filed 2-3-22; 8:45 am]
BILLING CODE 4150-28-P
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