88. Public Health Service (PHS) Increased-Risk Factors in Organ Donors: A Review of the OPTN Ad hoc Disease Transmission Advisory Committee (DTAC)

Abstract

BackgroundIn the United States, all deceased donors (DD) are evaluated for behavioral risk factors for human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection during the past 12 months. DD with behavioral risk factors or hemodilution are designated as PHS increased risk donors (IRD). Since 2013, the number of IRD has increased from 13.4% of DD to 27% in 2018. Despite a low residual risk of disease transmission after a negative nucleic acid test for HIV/HBV/HCV, the considerable underutilization of IRD has driven an interest in revising the PHS IRD 2013 guidelines. The objective of this study was to describe the epidemiology of IRD with the goal of guiding policy change and maximize organ use.MethodsThis is a retrospective cohort study of DD during 2018. Characteristics of IRD were compared with non-IRD. A random 10% sample of IRD was selected for manual review of text narratives and donor questionnaires submitted by organ procurement organizations to determine specific PHS IRD factors. Categorical variables were compared using the χ 2 test and continuous variables were compared using a 2-sample t-test for independent samples.ResultsAmong 10,721 DD in 2018, 2,904 were designated IRD (27.1%) with regional variability noted (Figure). Compared with non-IRD, IRD were younger (median age 35 vs. 45 years, P < 0.001) and more often died from drug intoxication (33.2 vs. 5.6%, P < 0.001). Hemodilution was found in 6.8% of all IRD and was the only factor for IRD designation in 60% of pediatric donors <12 years old. The random sample of IRD (N = 288) was similar to IRD population for age, gender, ethnicity, cause of death, and region of recovery (table). Descriptive analysis of the random sample showed that intravenous drug use was the most common behavioral risk factor (N = 124, 43.1%), followed by incarceration (N = 108, 37.5%). Most DD met only 1 criterion (N = 179, 62%); 21% met 2 criteria; and 17% had >3 criteria.ConclusionThis study represents the most detailed description of PHS IRD factors since the adoption of the new guidelines in 2013. Understanding the prevalence of factors that lead to IRD designation will help inform future policy development, optimize safe DD use, and increase the number of transplants. Disclosures All Authors: No reported Disclosures.

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

“…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.…”

“…Although OPTN does not routinely collect data on specific criteria resulting in IRD designations, a recent analysis was conducted to determine the criteria resulting in IRD designation among a random sample of IRDs during 2018 (45). Among 179 IRDs with only one risk factor resulting in designation, 12% had received outpatient hemodialysis, 12% were designated IRDs because of hemodilution of the specimen used for infectious disease testing, and 6% had a recent diagnosis of an STD or recent treatment for an STD (45).…”

“…Although OPTN does not routinely collect data on specific criteria resulting in IRD designations, a recent analysis was conducted to determine the criteria resulting in IRD designation among a random sample of IRDs during 2018 (45). Among 179 IRDs with only one risk factor resulting in designation, 12% had received outpatient hemodialysis, 12% were designated IRDs because of hemodilution of the specimen used for infectious disease testing, and 6% had a recent diagnosis of an STD or recent treatment for an STD (45). In addition, no donors were designated as IRDs because they were a woman who had had sex with a man who had had sex with another man or because they were a child breastfed by a mother with or at risk for HIV; only 0.6% were designated an IRD because they were a child born to a mother infected with or at increased risk for infection with HIV, HBV, or HCV (45).…”

Cost-effectiveness of Kidney Transplantation From Donors at Increased Risk of Blood-borne Virus Infection Transmission

“…56 As of 2018, 27% (2904) of all the deceased donors in the United States were increased-risk donors. 57 In the United Kingdom, between 2003 and 2015, donors with increased risk behaviors provided 694 kidneys with transplant outcomes similar to recipients of organs from donors without increased risk behaviors. 53 However, higher decline rates and subjective perception of the higher risk of BBV transmission to kidney transplant recipients result in the underutilization of this valuable resource.…”

Successful Implementation of an Increased Viral Risk Donor Waiting List for Preconsented Kidney Transplant Candidates in Victoria, Australia

“…[4][5][6][7][8][9][10][11] This has led to kidneys from IVRDs being increasingly utilized in countries including the United States of America (USA), where IVRDs have risen to 27.1% of deceased donors in 2018. 12,13 At the time of writing, the last reported cases of HIV transmission from deceased 14 or living 15 donors in the USA was in 2007 and 2009, respectively. The availability of hepatitis B virus (HBV) vaccination and antiviral agents, and the highly effective and well-tolerated direct-acting antivirals for hepatitis C virus (HCV), also substantially reduce the consequences of potential disease transmission.…”