1. Ad-hoc Disease Transmission Advisory Committee
Guidance on Explaining Risk Related to Use of Increased Risk Donor Organs When Considering Organ Offers
Ad-hoc Disease Transmission Advisory Committee

2. What problem will the proposal solve?
OPTN data show that increased risk donors have increased substantially over time
Reluctance to use organs from increased risk donors due to perceptions that it may translate to poor outcomes
In July 2013, the U.S. Public Health Service (PHS) published new guidelines for reducing HIV, HBV, and HCV transmission through organ transplantation.
OPTN data shows that Increased Risk donors has gone up substantially over time
Some transplant programs are reluctant to use organs from deceased donors that meet increased risk criteria due to perceptions that it may translate to poor recipient or graft survival.

3. What are the proposed solutions?
The transplant community has requested assistance how to best explain relative risk of disease transmission involving increased risk organ donors to potential organ recipients
A guidance document for providers which includes:
Executive Summary with speaking points for transplant program staff
Risk of disease transmission versus risk of death from other causes
Risk of declining an organ from a donor that met PHS guidelines for increased risk of HIV, HBV and HCV infection versus remaining on the waiting list
Consequences of transmission of HIV, HBV, and HCV
Risk of acquiring HCV on hemodialysis
Limitations of current screening technology
Goal – transplant organs that would otherwise be discarded and reduce the amount of time for organ allocation efforts
The transplant community requested assistance how to best explain relative risk of disease transmission involving increased risk organ donors to potential organ recipients. During the summer and fall of 2016, DTAC & representatives of AST, ASTS, and NATCO created a guidance document for transplant providers and OPOs. By educating providers, they will be better informed to counsel patients during transplant evaluations as well as consider risk when receiving organ offers.
The guidance includes:
Executive Summary with speaking points for transplant program staff
Graphic renderings to describe the risk of disease transmission compared to the risk of death from other causes
Risk of declining an organ from a donor that met PHS guidelines for increased risk of HIV, HBV and HCV infection versus remaining on the waiting list
Consequences of transmission of HIV, HBV, and HCV
Risk of acquiring HCV on hemodialysis
Limitations of current screening technology
This document is expected to impact transplant programs and OPOs. The goal is enhanced understanding that disease transmission risk involving organs from increased risk donors may lead to a greater number of organ transplants that may otherwise be discarded, increase the number of organs recovered per donor, or reduce the amount of time for organ allocation efforts.

4. Supporting Evidence
The number of deceased donors that met either CDC High Risk (pre-October 2013), or U.S. Public Health Service (post-October 2013) has increased over time. The red line in this slide denotes the transition to the new criteria. The Committee does not believe the change in definition is the central factor in the increase in increased risk donors. The current opioid epidemic and increased prevalence of risk behaviors has played a role in this increase as well.
Based on OPTN data as of May 27, 2016

5. Estimated risk of window period infection (per 10,000 donors)
Supporting Evidence
Estimated risk of window period infection (per 10,000 donors)
Risk per 10,000 donors
HIV ELISA
HIV NAT
HCV ELISA
HCV NAT
Men who have sex with men
10.2 (0.10%)
4.2 (<0.1%)
32.5 (0.33%)
3.5 (<0.1%)
IV drug users
12.1 (0.12%)
4.9 (<0.1%)
300.6 (3%)
32.4 (0.32%)
Hemophiliacs
0.086 (<0.01%)
0.035 (<0.01%)
0.26 (<0.1%)
0.027 (<0.01%)
Commercial sex worker
6.6 (<0.1%)
2.7 (<0.1%)
114.9 (1.2%)
12.3 (0.12%)
Sex with a partner in above categories
0.7 (<0.1%)
0.3 (<0.1%)
Blood product exposure
1.5 (<0.1%)
0.6 (<0.1%)
4 (<0.1%)
0.4 (<0.1%)
Incarceration
2.3 (<0.1%)
0.9 (<0.1%)
7.2 (<0.1%)
0.8 (<0.1%)
A literature review was performed to gather current information on the risk of HIV or HCV transmission in the window period of prevalent testing used in donor screening. Though not based on actual case data, the mathematical projections of risk from deceased donors tested during the respective window periods vary based on risk behavior. As you can see from the data on the slide, the risk of undetected infection for differs dramatically between ELISA and NAT testing, with the lowest risk of missing an infection associated with NAT testing. The calculated risk is shown both as a ratio (per 10,000 donors) and as a percentage.
I would like to discuss the risk associated with two behaviors often reported in deceased donors, men with same-sex partners and IV drug users.
Kucirka, LM, Bowring,,MG, Massie, AB, Luo, X, Nicholas, LH, Segev, DL, "Landscape of Deceased Donors Labeled Increased Risk for Disease Transmission Under New Guidelines. "American Journal of Transplantation 15, no. 12 (2015):
Kucirka, LM, Sarathy, H, Govindan, P, Wolf, JH, Ellison, TA, Hart, LJ, et al, "Risk of Window Period Hepatitis-C Infection in High Infectious Risk Donors: Systematic Review and Meta-analysis," American Journal of Transplantation 11, no. 6 (2011):

6. Estimated risk of window period infection (per 10,000 donors)
Supporting Evidence
Estimated risk of window period infection (per 10,000 donors)
Risk per 10,000 donors
HIV ELISA
HIV NAT
HCV ELISA
HCV NAT
Men who have sex with men
10.2 (0.10%)
4.2 (<0.1%)
32.5 (0.33%)
3.5 (<0.1%)
IV drug users
12.1 (0.12%)
4.9 (<0.1%)
300.6 (3%)
32.4 (0.32%)
Hemophiliacs
0.086 (<0.01%)
0.035 (<0.01%)
0.26 (<0.1%)
0.027 (<0.01%)
Commercial sex worker
6.6 (<0.1%)
2.7 (<0.1%)
114.9 (1.2%)
12.3 (0.12%)
Sex with a partner in above categories
0.7 (<0.1%)
0.3 (<0.1%)
Blood product exposure
1.5 (<0.1%)
0.6 (<0.1%)
4 (<0.1%)
0.4 (<0.1%)
Incarceration
2.3 (<0.1%)
0.9 (<0.1%)
7.2 (<0.1%)
0.8 (<0.1%)
The red highlighted content reflects the risk for an organ from a male donor who had sexual contact with other men. With ELISA testing, the risk of undetected HIV infection is 10.2 per 10,000, or 0.1 percent. With NAT testing for HIV, this risk drops to 4.2 per 10,000 or less than 0.1 percent. The risk of undetected HCV showed a similar drop in risk of undetected infection; 32.5 per 10,000 donors or 0.33 percent with ELISA, and 3.5 per 10,000 donors or less than 0.1 percent with NAT.
Kucirka, LM, Bowring,,MG, Massie, AB, Luo, X, Nicholas, LH, Segev, DL, "Landscape of Deceased Donors Labeled Increased Risk for Disease Transmission Under New Guidelines. "American Journal of Transplantation 15, no. 12 (2015):
Kucirka, LM, Sarathy, H, Govindan, P, Wolf, JH, Ellison, TA, Hart, LJ, et al, "Risk of Window Period Hepatitis-C Infection in High Infectious Risk Donors: Systematic Review and Meta-analysis," American Journal of Transplantation 11, no. 6 (2011):

7. Estimated risk of window period infection (per 10,000 donors)
Supporting Evidence
Estimated risk of window period infection (per 10,000 donors)
Risk per 10,000 donors
HIV ELISA
HIV NAT
HCV ELISA
HCV NAT
Men who have sex with men
10.2 (0.10%)
4.2 (<0.1%)
32.5 (0.33%)
3.5 (<0.1%)
IV drug users
12.1 (0.12%)
4.9 (<0.1%)
300.6 (3%)
32.4 (0.32%)
Hemophiliacs
0.086 (<0.01%)
0.035 (<0.01%)
0.26 (<0.1%)
0.027 (<0.01%)
Commercial sex worker
6.6 (<0.1%)
2.7 (<0.1%)
114.9 (1.2%)
12.3 (0.12%)
Sex with a partner in above categories
0.7 (<0.1%)
0.3 (<0.1%)
Blood product exposure
1.5 (<0.1%)
0.6 (<0.1%)
4 (<0.1%)
0.4 (<0.1%)
Incarceration
2.3 (<0.1%)
0.9 (<0.1%)
7.2 (<0.1%)
0.8 (<0.1%)
The blue highlighted content reflects the risk for an organ from a potential donor who has a history of IV drug use. As with the prior risk behavior, a similar reduction in risk is noted between ELISA and NAT for undetected HCV transmission; 12.1 per 10,000 or 0.12 percent for HIV with ELISA, or 4.9 per 10,000 or less than 0.1 percent with NAT. For HCV, the risk is per 10,000 or 3 percent with ELISA, or 32.4 per 10,000 or 0.32 percent for NAT.
This donor’s risk behavior needs to be carefully considered by the transplant team when evaluating organ offers. This data shows the risk of missing a HIV or HCV infection due to testing within the window periods of ELISA or NAT is very low.
Kucirka, LM, Bowring,,MG, Massie, AB, Luo, X, Nicholas, LH, Segev, DL, "Landscape of Deceased Donors Labeled Increased Risk for Disease Transmission Under New Guidelines. "American Journal of Transplantation 15, no. 12 (2015):
Kucirka, LM, Sarathy, H, Govindan, P, Wolf, JH, Ellison, TA, Hart, LJ, et al, "Risk of Window Period Hepatitis-C Infection in High Infectious Risk Donors: Systematic Review and Meta-analysis," American Journal of Transplantation 11, no. 6 (2011):

8. Supporting Evidence
In light of the current opioid epidemic, the U.S. Centers for Disease Control and Prevention examined the risk of HIV or HCV despite negative nucleic acid testing among increased-risk organ donors. Their modeling noted a very low risk that declines with the passage of time from the most recent risk behavior.
Modified from: Annambhotla PD, Gurbaxani BM, Kuehnert MJ, Basavaraju SV, “A model to estimate the probability of human immunodeficiency virus and hepatitis C infection despite negative nucleic acid testing among increased-risk organ donors”. Transplant Infectious Disease, 2017 Feb 8. doi: /tid.12676

9. Supporting Evidence
Risk of getting HIV or HCV from a “PHS increased risk” organ versus risk of dying from a traffic accident
The Committee decided to convey the risk of disease transmission relative to other risks that patient may encounter in the course of their lives. This graphic from the guidance document illustrates the risk relative to death from a traffic accident.
Kucirka, LM, et al, Risk of Window Period HIV Infection in High Infectious Risk Donors: Systematic Review and Meta-Analysis”, American Journal of Transplantation 11, no 6 (2011): Images created by Iconarray.com. Risk Science Center and Center for Bioethics and Social Sciences in Medicine, University of Michigan. Accessed November 22, 2016
Kucirka, LM, “Risk of Window Period Hepatitis-C Infection in High Infectious Risk Donors: Systematic Review and Meta-Analysis”, American Journal of Transplantation 11, no 6 (2011): Images created by Iconarray.com. Risk Science Center and Center for Bioethics and Social Sciences in Medicine, University of Michigan. Accessed November 22, 2016

10. How will members implement this proposal?
Transplant hospitals may use this as a resource for staff at their transplant programs
Optional resource to help with patient discussions
Transplant hospitals may elect to use this as a resource for staff at their transplant programs. Use of this guidance document is optional, and is intended to provide information that can be used in discussions with patients.

11. How will the OPTN implement this proposal?
Board consideration in June 2017
If approved, instructional program will be developed
Guidance from the OPTN does not carry the weight of policies or bylaws
The target for consideration by the OPTN/UNOS Board of Directors is June If approved by the Board, this guidance will be made available to the community shortly after the meeting on the OPTN and TransplantPro websites.
Due to community interest and the complexity surrounding this topic, an instructional program will be developed once the guidance is approved by the Board. The OPTN anticipates that there will be questions from the community related to information within the guidance, and thus will provide an opportunity for subject matters experts to speak on the topic and answer those questions. The OPTN will communicate this new information through TransplantPro and the OPTN website.
With regard to evaluating member compliance, guidance documents from the OPTN do not carry the weight of policies or bylaws. Therefore, members will not be evaluated for compliance with this document.

12. Questions? Cameron R. Wolfe, M.D. Committee Chair
Christopher L. Wholley, M.S.A.
Committee Liaison