Table 1.

Risk criteria	No. of donors associated with donor-derived transmission events
Risk criteria	HIV	HBV	HCV
No. of donors associated with transmission events	1	14	23
No. of donors with criteria resulting in IRD designation^†
Sex with a person known or suspected to have HIV, HBV, or HCV infection	0	0	2
Man who has had sex with another man	1	0	0
Woman who has had sex with a man who has had sex with another man	0	0	0
Sex in exchange for money or drugs	0	1	4
Sex with a person who had sex in exchange for money or drugs	0	4	2
Drug injection for nonmedical reasons	0	10	19
Sex with person who injected drugs for nonmedical reasons	0	5	4
Incarceration (confinement in jail, prison, or juvenile correction facility) for ≥72 consecutive hours	0	8	10
Newly diagnosed or treated syphilis, gonorrhea, chlamydia, or genital ulcers	0	1	0
Child (aged ≤18 months) born to a mother known to be infected with or at increased risk for HIV, HBV, or HCV infection	0	0	0
Child breastfed by a mother known to be infected with or at increased risk for HIV infection	0	0	0
Hemodialysis	0	0	0
Unknown medical or social history	0	1	2
Hemodiluted blood specimen used for donor HIV, HBV, or HCV testing	0	0	0

Table 1. Number of increased risk donors* and risk criteria associated with donor-derived human immunodeficiency virus, hepatitis B, and hepatitis C transmission events reported to the Organ Procurement and Transplantation Network Disease Transmission Advisory Committee — United States, 2008–2018

Source: Organ Procurement and Transplantation Network. Organ Procurement and Transplantation Network Disease Transmission Advisory Committee report database. Richmond, VA: US Department of Health and Human Services, Health Resources and Services, Organ Procurement and Transplantation Network; 2019. https://optn.transplant.hrsa.gov/members/committees/disease-transmission-advisory-committee.

Abbreviations: HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; IRD = increased risk donor.

* A total of 38 increased risk donors were identified. Each donor-derived transmission event was associated with a single virus only.

^† Increased risk donors could meet more than one risk criteria, and all criteria were included.

Box.

1. Initial transplant candidate informed consent discussion and vaccination
2. Risk assessment of living and deceased donors
3. Living and deceased solid organ donor testing
4. Transplant candidate informed consent discussion, including donor risk factors
5. Recipient testing
6. Collection and storage of donor and recipient specimens
7. Tracking and reporting of donor-derived disease transmission events

BOX. Steps in the organ transplantation process related to the U.S. Public Health Service guideline recommendations for assessing solid organ donors and monitoring transplant recipients for human immunodeficiency virus, hepatitis B virus, and hepatitis C virus infection

Table 2.

Recommendation category	2013	2020
Risk assessment of living and deceased donors	• OPOs should ascertain whether any of the following 14 risk criteria were present in potential organ donors.	• OPOs should ascertain whether any of the following 10 risk criteria were present in potential organ donors.
	• Donors with any risk criteria should be designated as IRDs for an acute HIV, HBV, and HCV infection.	• Remove any specific label (e.g., “increased risk donor”) to describe donors with risk factors for acute HIV, HBV, and HCV infection.
	• Risk criteria (during the 12 months before organ procurement): 1. Sex with a person known or suspected to have HIV, HBV, or HCV infection 2. Drug injection for nonmedical reasons 3. Man who has had sex with another man 4. Incarceration (confinement in jail, prison, or juvenile correction facility) for ≥72 consecutive hours 5. Sex in exchange for money or drugs 6. Sex with a person who injected drugs for nonmedical reasons 7. Sex with a person who had sex in exchange for money or drugs 8. Unknown medical or social history 9. Child aged ≤18 months born to a mother known to be infected with or at increased risk for HIV, HBV, or HCV infection 10. Child who has been breastfed by a mother who is known to be infected with or at increased risk for HIV infection 11. Woman who has had sex with a man who has had sex with another man 12. Newly diagnosed or treated syphilis, gonorrhea, chlamydia, or genital ulcers 13. Hemodialysis 14. Hemodilution of the blood sample used for infectious disease testing	• Risk criteria (during the 30 days before organ procurement): 1. Sex (i.e., any method of sexual contact, including vaginal, anal, and oral) with a person known or suspected to have HIV, HBV, or HCV infection 2. Man who has had sex with another man 3. Sex in exchange for money or drugs 4. Sex with a person who had sex in exchange for money or drugs 5. Drug injection for nonmedical reasons 6. Sex with a person who injected drugs for nonmedical reasons 7. Incarceration (confinement in jail, prison, or juvenile correction facility) for ≥72 consecutive hours 8. Child breastfed by a mother with HIV infection 9. Child born to a mother with HIV, HBV, or HCV infection 10. Unknown medical or social history
Living and deceased solid organ donor testing	• Test all potential organ donors (living and deceased) ○ HIV: anti-HIV-1/2 or HIV Ag/Ab combination assay ○ HBV: Anti HBc and HBsAg ○ HCV: NAT and anti-HCV ○ For IRD only, HIV NAT or HIV Ag/Ab combination	• Test all potential organ donors (living and deceased) ○ HIV: NAT and anti-HIV ○ HBV: NAT, anti-HBc, and HBsAg ○ HCV: NAT and anti-HCV
	• No time frame is specified for pretransplant deceased donor testing; however, results should be available at the time of transplant.	• For deceased potential donors, the donor specimen should be collected within 96 hours before organ procurement with results of these screening tests available at the time of organ procurement.
	• Living donors should be tested within 28 days before transplantation.	• For living potential donors, testing should be performed as close as possible to the surgery but at least within the 28 days before organ procurement.
Transplant candidate informed consent	• Transplant center to obtain separate, specific informed consent from transplant candidates when donors are designated as IRDs	• When donors with one or more of the criteria as specified under Risk Assessment of Living and Deceased Donors are identified, OPOs should communicate this information to the appropriate transplant centers. Transplant centers should include this information in informed consent discussions with transplant candidates or their medical decision-makers. No separate, specific informed consent is recommended.
Transplant candidate informed consent		• Transplant centers should contextualize these discussions by including that risk for undetected HIV, HBV, and HCV infection is very low but not zero; should transmission occur effective therapies are available, and accepting organs from donors with risk factors might increase the chance for survival.^†
Recipient testing and vaccination	• Pretransplant testing of transplant candidates for HIV, HBV, and HCV infections is recommended when the donor (living or deceased) is designated as IRD or infected with HBV or HCV. ○ Type of assay not specified ○ Timing: during hospital admission for transplant but before transplant	• Pretransplant testing for HIV, HBV, and HCV infections should be conducted for all recipients, regardless of donor risk criteria. ○ HIV: testing algorithm^§ ○ HBV: anti-HBc, anti-HBs, and HBsAg ○ HCV: NAT and anti-HCV ○ Timing: During hospital admission for transplant but before transplant
	• Regardless of 2013 guideline recommendations, Organ Procurement and Transplantation Network policy requires all transplant candidates to be tested for HIV, HBV, and HCV.
	• Posttransplant testing of organ recipients for HIV, HBV, and HCV infections should be conducted when the donor (living or deceased) is designated as IRD or infected with HBV or HCV. ○ Type of testing is not specified. ○ Timing: testing should be performed at 1–3 months posttransplant for HIV, HBV, and HCV and again at 12 months for HBV.	• Posttransplant testing for HIV, HBV, and HCV infections should be conducted for all recipients, regardless of donor risk criteria. ○ Type of testing: NAT for HIV, HBV, and HCV ○ Timing: 4–6 weeks posttransplant ○ Clinicians caring for liver recipients should maintain heightened awareness of the potential for delayed appearance of HBV infection and consider additional testing for HBV NAT at 1 year. ○ Recipients who develop signs or symptoms of liver injury after transplantation should be retested for viral hepatitis.
	• No previous PHS guideline recommendation exists for HBV vaccination of transplant candidates.	• All organ transplant candidates should be vaccinated against HBV infection.
Collection and storage of donor and recipient specimens	• OPOs should consider archiving a deceased donor blood sample for 10 years.	• OPOs and living donor recovery centers should archive donor blood specimens for at least 10 years. These specimens should be collected within 24 hours before organ procurement.
Collection and storage of donor and recipient specimens	• No specific time frame is given for collection of archived samples relative to organ procurement.
Tracking and reporting of donor-derived disease transmission events^¶

Table 2. Comparison of 2013 and 2020 U.S. Public Health Service guideline recommendations* for solid organ donor assessment and transplant recipient monitoring for human immunodeficiency virus, hepatitis B virus, and hepatitis C virus infection

Abbreviations: anti-HBc = antibodies to hepatitis B virus core antigen; anti-HCV= antibodies to hepatitis C virus; anti-HIV-1/2 = antibodies to HIV-1/2; HbsAg = hepatitis B surface antigen; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; IRD = increased risk donor; OPO = organ procurement organization; NAT = nucleic acid testing.

* Only recommendations that were substantially modified from 2013 to 2020 are included. Recommendations that have minor wording changes or have been reorganized are not shown.

^† Sources: Bixler D, Annambholta P, Abara WE, et al. Hepatitis B and C virus infections transmitted through organ transplantation investigated by CDC, United States, 2014–2017. Am J Transplant 2019;19:2570–82; Jones JM, Gurbaxani BM, Asher A, et al. Quantifying the risk of undetected HIV, hepatitis B virus, or hepatitis C virus infection in Public Health Service increased risk donors. Am J Transplant 2019;19:2583–93; US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Bethesda, MD: US Department of Health and Human Services, National Institutes of Health, Office of AIDS Research Advisory Council. https://aidsinfo.nih.gov/contentfiles/adultandadolescentgl.pdf; Chung RT, Ghany MG, Kim AY, et al; AASLD-IDSA HCV Guidance Panel. Hepatitis C guidance 2018 update: AASLD-IDSA recommendations for testing, managing, and treating hepatitis C virus infection. Clin Infect Dis 2018;67:1477–92; Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology 2018;67:1560–99; Bowring MG, Holscher CM, Zhou S, et al. Turn down for what? Patient outcomes associated with declining increased infectious risk kidneys. Am J Transplant 2018;18:617–24; Croome KP, Lee DD, Pungpapong S, Keaveny AP, Taner CB. What are the outcomes of declining a Public Health Service increased risk liver donor for patients on the liver transplant waiting list? Liver Transpl 2018;24:497–504.

^§ Source: CDC; Association of Public Health Laboratories. Laboratory testing for the diagnosis of HIV infection: updated recommendations. Atlanta, GA: US Department of Health and Human Services, CDC. https://stacks.cdc.gov/view/cdc/23447.

^¶ No recommendations in this category were substantially modified from 2013 to 2020.

Table 3.

Donor or recipient	Type of assay	Timing of testing
Deceased donor	Anti-HIV and HIV NAT; total anti-HBc, HBsAg, and HBV NAT; anti-HCV and HCV NAT	96 hours before organ procurement
Living donor	Anti-HIV and HIV NAT; total anti-HBc, HBsAg, and HBV NAT; anti-HCV and HCV NAT	As close as possible to the surgery but at least within 28 days before organ procurement
Transplant candidate (pretransplant)	CDC HIV testing algorithm*; total anti-HBc, HBsAg, and anti-HBs; anti-HCV and HCV NAT	Before transplantation during hospital admission for transplant
Transplant recipient (posttransplant)	HIV, HBV, and HCV NAT	4–6 weeks after transplant^†

Table 3. Testing recommendations for deceased and living donors and for transplant recipients, by type of assay and timing of testing

Abbreviations: anti-HBc = antibodies to hepatitis B virus core antigen; anti-HCV = antibodies to hepatitis C virus; anti-HIV-1/2 = antibodies to HIV-1/2; HbsAg = hepatitis B surface antigen; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; NAT = nucleic acid testing.

* Source: CDC; Association of Public Health Laboratories. Laboratory testing for the diagnosis of HIV infection: updated recommendations. Atlanta, GA: US Department of Health and Human Services, CDC. https://stacks.cdc.gov/view/cdc/23447.

^† Clinicians caring for liver recipients should maintain heightened awareness of the potential for delayed appearance of HBV infection and consider additional testing for HBV NAT at 1 year. Solid organ recipients who develop signs or symptoms of liver injury (e.g., jaundice or elevated liver function tests) after transplantation should be retested for viral hepatitis even if previous hepatitis B and hepatitis C testing was negative.

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Durand CM, Bowring MG, Brown DM, Direct-acting antiviral prophylaxis in kidney transplantation from hepatitis C virus-infected donors to noninfected recipients. Ann Intern Med 2018;168:533–40. 10.7326/M17-287129507971
Goldberg DS, Abt PL, Blumberg EA, Trial of transplantation of HCV-infected kidneys into uninfected recipients. N Engl J Med 2017;376:2394–5. 10.1056/NEJMc170522128459186
Reese PP, Abt PL, Blumberg EA, Twelve-month outcomes after transplant of hepatitis C-infected kidneys into uninfected recipients: a single-group trial. Ann Intern Med 2018;169:273–81. 10.7326/M18-074930083748
Reese PP, Abt PL, Blumberg EA, Goldberg DS. Transplanting hepatitis C-positive kidneys. N Engl J Med 2015;373:303–5. 10.1056/NEJMp150507426200976
Singh N, Neidlinger N, Djamali A, The impact of hepatitis C virus donor and recipient status on long-term kidney transplant outcomes: University of Wisconsin experience. Clin Transplant 2012;26:684–93. 10.1111/j.1399-0012.2011.01583.x22283142
Gasink LB, Blumberg EA, Localio AR, Desai SS, Israni AK, Lautenbach E. Hepatitis C virus seropositivity in organ donors and survival in heart transplant recipients. JAMA 2006;296:1843–50. 10.1001/jama.296.15.184317047214
McLean RC, Reese PP, Acker M, Transplanting hepatitis C virus-infected hearts into uninfected recipients: a single-arm trial. Am J Transplant 2019;19:2533–42. 10.1111/ajt.1531130768838
Woolley AE, Singh SK, Goldberg HJ, ; DONATE HCV Trial Team. Heart and lung transplants from HCV-infected donors to uninfected recipients. N Engl J Med 2019;380:1606–17. 10.1056/NEJMoa181240630946553
Molnar MZ, Nair S, Cseprekal O, Transplantation of kidneys from hepatitis C-infected donors to hepatitis C-negative recipients: single center experience. Am J Transplant 2019;19:3046–57. 10.1111/ajt.1553031306549
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CDC. Viral hepatitis surveillance—United States. Atlanta, GA: US Department of Health and Human Services, CDC. https://www.cdc.gov/hepatitis/statistics/SurveillanceRpts.htm
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CME / ABIM MOC / CE

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

Authors: Jefferson M. Jones, MD; Ian Kracalik, PhD; Marilyn E. Levi, MD; James S. Bowman III, MD; James J. Berger; Danae Bixler, MD; Kate Buchacz, PhD; Anne Moorman, MPH; John T. Brooks, MD; Sridhar V. Basavaraju, MD
CME / ABIM MOC / CE Released: 1/8/2021
THIS ACTIVITY HAS EXPIRED
Valid for credit through: 1/8/2022

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Target Audience and Goal Statement

This activity is intended for organ transplant physicians, infectious disease clinicians, hematologists/oncologists, nephrologists, hepatologists, laboratory medicine practitioners, and other clinicians involved in organ transplantation.

The goal of this activity is to describe new recommendations for reducing transmission of HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) through organ transplantation, according to US Public Health Service updated guidelines.

Upon completion of this activity, participants will be able to:

Describe rationale and principles for use of new USPHS recommendations for assessing donors for HIV, HBV, HCV risk and monitoring recipients for transmission of these infections through organ transplantation
Identify key changes in the 2020 USPH guideline recommendations compared to the 2013 guideline recommendations
Identify other recommendations for assessing donors for HIV, HBV, or HCV risk, reducing the risk of transmission to recipients, and mitigating poor outcomes as a result of disease transmission according to the updated Guideline

Disclosures

As an organization accredited by the ACCME, Medscape, LLC, requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.

Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.

Authors

Jefferson M. Jones, MD

Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention (CDC)
Atlanta, Georgia

Disclosures

Disclosure: Jefferson M. Jones, MD, has disclosed no relevant financial relationships.

Ian Kracalik, PhD

Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention (CDC)
Atlanta, Georgia

Disclosures

Disclosure: Ian Kracalik, PhD, has disclosed no relevant financial relationships.

Marilyn E. Levi, MD

Division of Transplantation, Healthcare Systems Bureau
Health Resources and Services Administration
Rockville, Maryland

Disclosures

Disclosure: Marilyn E. Levi, MD, has disclosed no relevant financial relationships.

James S. Bowman III, MD

Division of Transplantation
Healthcare Systems Bureau
Health Resources and Services Administration
Rockville, Maryland

Disclosures

Disclosure: James S. Bowman III, MD, has disclosed no relevant financial relationships.

James J. Berger

Office of Infectious Disease Policy
Office of the Assistant Secretary for Health
US Department of Health and Human Services
Washington, DC

Disclosures

Disclosure: James J. Berger has disclosed no relevant financial relationships.

Danae Bixler, MD

Division of Viral Hepatitis
Centers for Disease Control and Prevention (CDC)
Atlanta, Georgia

Disclosures

Disclosure: Danae Bixler, MD, has disclosed no relevant financial relationships.

Kate Buchacz, PhD

Division of HIV/AIDS Prevention
Centers for Disease Control and Prevention (CDC)
Atlanta, Georgia

Disclosures

Disclosure: Kate Buchacz, PhD, has disclosed no relevant financial relationships.

Anne Moorman, MPH

Division of Viral Hepatitis
Centers for Disease Control and Prevention (CDC)
Atlanta, Georgia

Disclosures

Disclosure: Anne Moorman, MPH, has disclosed no relevant financial relationships.

John T. Brooks, MD

Division of HIV/AIDS Prevention
Centers for Disease Control and Prevention (CDC)
Atlanta, Georgia

Disclosures

Disclosure: John T. Brooks, MD, has disclosed no relevant financial relationships.

Sridhar V. Basavaraju, MD

Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention (CDC)
Atlanta, Georgia

Disclosures

Disclosure: Sridhar V. Basavaraju, MD, has disclosed no relevant financial relationships.

CME Author

Laurie Barclay, MD

Freelance writer and reviewer
Medscape, LLC

Disclosures

Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

CME Reviewer/Nurse Planner

Hazel Dennison, DNP, RN, FNP, CHCP, CPHQ, CNE

Associate Director, Accreditation and Compliance
Medscape, LLC

Disclosures

Disclosure: Hazel Dennison, DNP, RN, FNP, CHCP, CPHQ, CNE, has disclosed no relevant financial relationships.

CE Reviewer

Esther Nyarko, PharmD

Associate Director, Accreditation and Compliance
Medscape, LLC

Disclosures

Disclosure: Esther Nyarko, PharmD, has disclosed no relevant financial relationships.

Medscape, LLC staff have disclosed that they have no relevant financial relationships.

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Medscape, LLC designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 2.0 MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

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Methods

PHS solicited feedback from its relevant agencies, subject-matter experts, additional stakeholders, and the public to revise recommendations. Data to support the development of revised recommendations were gathered during different phases by the following methods:

Original scientific studies were conducted by CDC to inform recommendation revisions related to donor risk assessment, donor testing, and recipient testing;
Data provided by OPTN related to organ donor risk assessment, donor testing, and HIV, HBV, or HCV transmission to recipients were reviewed;
A review of the literature was conducted to inform recommendations related to donor risk assessment;
Input was received from the Advisory Committee for Blood and Tissue Safety and Availability, a federal advisory committee that provides advice to the Secretary of U.S. Department of Health and Human Services (HHS) regarding blood, organ, and tissue policies; and
Input and feedback from the public solicited by posting draft recommendations in the Federal Register ^[42] for comment was reviewed.

Original Scientific Studies

CDC conducted scientific studies to determine HIV, HBV, and HCV infection donor laboratory screening practices and the proportion of donors classified as IRDs under policies implemented after publication of the 2013 PHS guideline ^[28]; estimate the risk for undetected HIV, HBV, or HCV infection in IRDs with negative laboratory screening test results ^[35]; characterize survival and graft function outcomes of organ recipients with donor-derived HBV or HCV infection ^[34]; and assess the impact of IRD designation on organ use ^[36]. These findings have been previously published and were presented to the Advisory Committee for Blood and Tissue Safety and Availability ^{[28],34–36,43}.

Review of OPTN Data and Review of Literature

The 2013 PHS guideline describes 12 medical or social criteria and two other criteria (unknown medical or social history and hemodilution of donor serum specimen used for testing) to assess the risk for recent HIV, HBV, or HCV infection among donors. These criteria were evaluated to determine whether their presence among organ donors was associated with a substantive risk for HIV, HBV, or HCV transmission to recipients despite negative donor serologic and nucleic acid screening test results because of an acute, undetected donor infection (i.e., a window period infection). For all criteria, two methods were used to assess this risk. First, CDC conducted a review of OPTN data on all donor-derived HIV, HBV, and HCV infections investigated, reviewed, and adjudicated by the OPTN ad hoc Disease Transmission Advisory Committee during 2008–2018 to identify reported donor risk criteria (Table 1). Second, CDC performed a review of published literature to determine which risk factors had previously been associated with donor-derived HIV, HBV, or HCV infection. The literature search resulted in 645 citations (Supplementary Appendix 1; https://stacks.cdc.gov/view/cdc/88644). All titles and abstracts were evaluated, and 86 articles that described transmission to recipients were reviewed in detail to ascertain donor risk factors for HIV, HBV, and HCV infections. In addition, the results of a systematic review performed to inform development of the 2013 PHS guideline were reviewed to identify pertinent transmission events ^[44]. Criteria that had been repeatedly reported to OPTN among donors who were associated with a HIV, HBV, or HCV transmission were not removed as risk criteria in the recommendations presented in this report. A review of the literature did not identify any articles that reported on donor criteria not already identified from a review of OPTN data or a previously known report on donor-derived HIV transmission resulting from hemodilution ^[10].

Four criteria were not described as donor risk factors in HIV, HBV, or HCV transmission events reported to the OPTN or identified through the literature search; two additional criteria had only been reported as donor risk factors once (Table 1). Of these six criteria, three (woman who has had sex with a man who has had sex with another man; child born to a mother known to be infected with or at increased risk for infection with HIV, HBV, or HCV; and child breastfed by a mother known to be infected with or at increased risk for HIV infection) have rarely been identified among donors and resulted in IRD designation ^[45]). The other three criteria (hemodialysis; newly diagnosed or treated syphilis, gonorrhea, chlamydia, or genital ulcers; and hemodilution of donor serum specimen used for testing) have frequently been identified among donors and resulted in an IRD designation ^[45] and were further evaluated.

Hemodialysis was included as a risk criterion in the 2013 PHS guideline because of reports of an association between HCV infection and outpatient dialysis ^[46,47]. To determine the extent to which hemodialysis increases the risk for acute HCV infection, data from additional sources, including the National Healthcare Safety Network Outpatient Dialysis Center Practices Survey, hepatitis C outbreaks reported to CDC, and the Dialysis Outcomes and Practice Patterns Study, were reviewed ^[48–50]. Newly diagnosed or treated syphilis, gonorrhea, chlamydia, or genital ulcers was included as a risk criterion in the 2013 PHS guideline as a marker primarily for potential acute HIV infection. Therefore, an additional literature search was conducted to ascertain the risk for acute HIV infection among persons with a recent diagnosis of a sexually transmitted disease (STD) in the United States (Supplementary Appendix 1; https://stacks.cdc.gov/view/cdc/88644).

Organ donors can receive infusions of crystalloid or colloid solution or blood products, resulting in a hemodiluted specimen, which can produce false-negative results for HIV, HBV, and HCV infection testing ^[1]. Hemodilution of a donor serum specimen used for testing has been reported only once before as a donor risk factor, when it resulted in a donor-derived HIV transmission event in 1986 ^[10,43]; the donor was screened with an HIV serology test. Hemodilution of donor serum has not been associated with donor-derived transmission of HIV, HBV, or HCV since then as new serologic tests, antigen tests, and NAT have been implemented. A man who has had sex with another man has been repeatedly reported as a risk factor for donor-derived HIV transmissions, most recently in 2009 ^[12].

Federal Advisory Committee Review and Recommendations

The Advisory Committee for Blood and Tissue Safety and Availability consists of 31 members, including subject-matter experts on blood, organ, or tissue safety; professional organization representatives; patient advocates; and nonvoting ex officio members from HHS ^[51]. All members are required to submit potential conflict of interest statements, which are reviewed by the Office of the Assistant Secretary of Health ethics office. No conflicts of interest were identified.

The committee was convened on April 15–16, 2019, to provide advice on revising the 2013 PHS guideline recommendations ^[43]. The committee considered epidemiologic data related to donor demographics and disease transmission events; scientific evidence pertaining to the efficacy of NAT (including in the setting of hemodilution) in identifying recently infected organ donors; current donor risk identification and HIV, HBV, and HCV infection screening methods; use of IRD organs; availability of effective therapies and transplant recipient outcomes for HIV, HBV, and HCV infections; and current practices for monitoring recipients for unexpected HIV, HBV, and HCV transmission. Members of external stakeholder groups presented opinions on the impact of the 2013 PHS guideline recommendations on organ safety, availability, and use and suggested revisions to the recommendations. The committee discussed the most appropriate terminology to characterize donors with risk factors for recent HIV, HBV, and HCV infections (e.g., IRD), which donor medical and social criteria are significantly associated with a risk for recent infection, and changes to donor and recipient testing recommendations. In addition, the committee provided specific input to improve transplant center and transplant candidate informed consent and decision-making and enhance organ use.

Among the committee’s pertinent recommendations were the following ^[43]:

Continue to recognize and designate a category of potential organ donors with an augmented chance of transmission of HIV, HBV, and HCV.
Screen all organ donors for HIV, HBV, and HCV infections using NAT in addition to serology.
Shorten the time frame during which donors are asked about risk criteria for recent HIV, HBV, or HCV infection from 12 months to 3 months.
Test all recipients using NAT, regardless of donor risk profile, for HIV, HBV, and HCV infections 2–4 weeks after transplantation.
Change the current “increased risk donor” terminology to reduce cognitive bias and improve decision making among clinicians and patients.
Remove the following as medical and social donor risk criteria:
- Woman who has had sex with a man who has had sex with another man
- Newly diagnosed or treated syphilis, gonorrhea, chlamydia, or genital ulcers
- Hemodialysis
- Hemodiluted blood specimen used for donor HIV, HBV, and HCV testing
- Child (aged ≤18 months) born to a mother at increased risk for HIV, HBV, or HCV infection
- Child breastfed by a mother at increased risk for HIV infection
Continue use of the following criteria that would result in augmented donor risk designation if present in the 3 months before organ procurement:
- Sex with a person known or suspected to have HIV, HBV, or HCV infection
- Man who has had sex with another man
- Sex in exchange for money or drugs
- Sex with a person who had sex in exchange for money or drugs
- Drug injection for nonmedical reasons
- Sex with a person who injected drugs for nonmedical reasons
- Incarceration (confinement in jail, prison, or juvenile correction facility) for ≥72 consecutive hours
- Unknown medical or social history
- Child born to a mother with HIV, HBV, or HCV infection
- Child breastfed by a mother with HIV infection
Support the development and use of tools and processes to educate transplant providers and enhance the process of transplant candidate counseling to increase organ use.

Public Comment on Proposed Revisions

The diversity of opinions expressed during the deliberations of the Advisory Committee for Blood and Tissue Safety and Availability were considered, including the use of a term to designate organ donors with HIV, HBV, or HCV infection risk factors. Proposed revisions to the 2013 PHS guideline recommendations were published in the Federal Register ^[42] on August 27, 2019, to solicit feedback from the public. During the comment period (August 27, 2019–October 10, 2019), 38 comments were received, including 21 from OPOs, eight from professional organizations, seven from transplant centers, and two from other organizations. These comments were reviewed and considered when developing and modifying recommendations.

Considerations for Transplanting Organs from Donors Infected with HCV

On August 27, 2019, a federal workshop was held to discuss transplantation of organs from HCV-viremic donors to HCV-negative recipients (Federal Workshop on Transplantation from Hepatitis C Infected Donors; unpublished data, 2019). Attendees included relevant representatives from federal agencies, transplant centers, and professional societies. Attendees gave presentations and discussed the epidemiology of HCV infections, ethics of transplanting organs from HCV-viremic donors to HCV-negative recipients, the use of direct acting antiviral (DAA) therapy as prophylaxis or treatment, and guiding principles for transplant centers to consider when transplanting organs from HCV-viremic donors to HCV-negative recipients. Considerations included in this guideline are based on this workshop and are not required to be incorporated into OPTN policy.

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Page 2 of 4

Recommendations

CME / ABIM MOC / CE Information

Table 1.

Box.

Table 2.

Table 3.

CME / ABIM MOC / CE

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

Target Audience and Goal Statement

Disclosures

Authors

Jefferson M. Jones, MD

Ian Kracalik, PhD

Marilyn E. Levi, MD

James S. Bowman III, MD

James J. Berger

Danae Bixler, MD

Kate Buchacz, PhD

Anne Moorman, MPH

John T. Brooks, MD

Sridhar V. Basavaraju, MD

CME Author

Laurie Barclay, MD

CME Reviewer/Nurse Planner

Hazel Dennison, DNP, RN, FNP, CHCP, CPHQ, CNE

CE Reviewer

Esther Nyarko, PharmD

Accreditation Statements

For Physicians

For Nurses

For Pharmacists

Instructions for Participation and Credit

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: Methods

Methods

Original Scientific Studies

Review of OPTN Data and Review of Literature

Federal Advisory Committee Review and Recommendations

Public Comment on Proposed Revisions

Considerations for Transplanting Organs from Donors Infected with HCV

Table of Contents

Table 1.

Box.

Table 2.

Table 3.

References

Faculty and Disclosures

Authors

Jefferson M. Jones, MD

Ian Kracalik, PhD

Marilyn E. Levi, MD

James S. Bowman III, MD

James J. Berger

Danae Bixler, MD

Kate Buchacz, PhD

Anne Moorman, MPH

John T. Brooks, MD

Sridhar V. Basavaraju, MD

CME Author

Laurie Barclay, MD

CME Reviewer/Nurse Planner

Hazel Dennison, DNP, RN, FNP, CHCP, CPHQ, CNE

CE Reviewer

Esther Nyarko, PharmD

CME / ABIM MOC / CE

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

Target Audience and Goal Statement

Disclosures

Authors

Jefferson M. Jones, MD

Ian Kracalik, PhD

Marilyn E. Levi, MD

James S. Bowman III, MD

James J. Berger

Danae Bixler, MD

Kate Buchacz, PhD

Anne Moorman, MPH

John T. Brooks, MD

Sridhar V. Basavaraju, MD

CME Author

Laurie Barclay, MD

CME Reviewer/Nurse Planner

Hazel Dennison, DNP, RN, FNP, CHCP, CPHQ, CNE

CE Reviewer

Esther Nyarko, PharmD

Accreditation Statements

For Physicians

For Nurses

For Pharmacists

Instructions for Participation and Credit

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: Methods

Methods

Original Scientific Studies

Review of OPTN Data and Review of Literature

Federal Advisory Committee Review and Recommendations

Public Comment on Proposed Revisions

Considerations for Transplanting Organs from Donors Infected with HCV

Table of Contents