This document discusses HIV transmission through organ transplantation from donors with risk factors. It provides data on cases of HIV transmission from donors with various risk factors like homosexual activity, intravenous drug use, and hemophilia. It also summarizes guidelines from 1994 from the CDC classifying high-risk donors and discusses the magnitude of high-risk donors based on various organ donation databases. Newer NAT testing has reduced but not eliminated residual risk of transmission from high-risk donors, and there remains a lack of data on the real incidence of transmission from average and high-risk donors.

1. Donor risk-HIV
Jacinto Sánchez Ibáñez
Director of the Regional Transplant Office in Galicia. Spain

5. NEJM

6. HIV
All cases before 2007
occurred before 1987
1981 1985 1987 1988-1992 2007 2010-2011
First cases described
first test available
first 7 cases reported
7 cases reported
6 cases reported
4 cases reported
7 organs transplanted
from HIV + donors

7. Cases of HIV transmission. Donor risk factor
Homosexual male: 3 donors, 6 organs transmitted
Hemodilution: 1 donor, 3 organs
Hemophilia: 1 donor 2 organs
(The “H” risk factor)
Intravenous drug abuse: 2 donors. 6 organs
Unknow: 3 donors, 7 organs

8. High-risk donor. CDC 1994
1. Men who have had sex with another man in the preceding 5
years
2. Persons who report nonmedical intravenous, intramuscular or
subcutaneos injection of drug in the preceding 5 years
3. Persons with hemophilia or related clotting disorders who
have received human-derived clotting factors concentrates
4. Men and women who have engaged in sex in exchange for
drugs or money in the preceding 5 years
5. Persons who have had sex in the preceding 12 months with
any person described in items 1-4 above or with a peerson
known or suspected to have HIV infection
6. Persons who have been exposed in the preceding 12 months
to know or suspected HIV-infected blood through
percutaneous inoculation ot through contact within an open
wound, nonintact skin or mucous membrane.
7. Inmates of correctional systems

9. High-risk donor
1. Children born to mothers with HIV infection or mothers who
meet the behavioral or laboratory exclusionary criteria for
adut donor unless HIV infection can be definitely excluded
2. Persons who cannot be tested for HIV because of
hemodilution.
3. Person whose history, physical exam, medical records or
autopsy records reveal others evidence of HIV infection or
high-risk behaviour, such us a diagnosis of AIDS, unexplained
lymphadenopathy lasting > 1 month, unexplained temperature
> 38,5ºC for > 10 days, unexplained persistent cough and
shorteness of breath, opportunistic infections, unexplained
persistent diarrhea, male-to-male sexual contact, sexually
transmitted diseases or needle tracks or others signs of
parenteral drug abuse.

11. What is the magnitude of high risk donors?
• UNOS database: CDC donors (no separation, IV drug = prisoner)
• CDC donors provided 7,3 % of all transplanted kidneys in USA
• 75 % of renal transplant teams use CDC donors
Am J Transplant 2009; 9 (10): 2338-2345

12. What is the magnitude of high risk donors?
ONT. Quality assurance of the donation process
• 1999-2009: 23,354 brain death
• IV Drug abusers and other risk factors: 368 (1.6%)
• Active viral infections: 424 (1.8%)
Galicia. Quality assurance of the donation process
• 2006-2010: 811 brain deaths
• IV Drug abusers and other risk factors: 9 (1.1%)
• HIV positive: 6 (0.7%)

13. Blood banking USA:
Add NAT test (RNA) prevent transmission of 5 HIV-1 infection
and 56 HCV infections annually.
Residual risk: 1/2.000.000 blood units
NEJM: 2004,351;8:760-768
Blood banking Spain:
Add NAT test (RNA) prevent transmission less than 1 HIV-1
infection and 6 HCV infections annually.
Eurosurveillance: 2005,vol 10, issue 2
Self exclusion

14. Tissue donors Australia:
1993-2004:
Estimated probability of viremia (add NAT test):
HIV: 1/128.000 (1/315.000)
HBV: 1/189.000 (1/385.000)
HCV: 1/55.000 (1/500.000)
Cost-benefit analysis is required
Am J of Transp: 2007;7:2723-2726

15. •Case of blood donor with primary HIV-1 infection in whom HIV
NAT screening was negative (genetic variation in the gag region)
•Circulating recombinant forms of HIV-1 are responsible for a
growing proportion of infectious thoughout the world (18% in
2004)
Transfusion: 2011;51(4):719-730

16. Serological diagnosis
Objectives of HIV antibodies detection test:
1. Biological security: blood, organ, tissue donors
2. Diagnosis of HIV infection
3. Biovigilance
4. Research
EIA/ELFA 4th generation, antibodies against HIV-1, HIV-2,
HIV-1 “O” and detection of HIV-p24 antigen

17. Sensibility of different HIV diagnosis methods in the acute infection
Days

18. Limitation of HIV DNA
12 February 2004: HIV DNA negative
Porno films: 13 female negative, later 3 +
17 March 2004: HIV DNA negative
9 April 2004: HIV DNA positive

19. How is this problem managed?
• UNOS database: July 2004-May 2008 (donors from whom at least
one organ was transplanted
• High risk donor from 2.3% to 26.1% (not correlate with AIDS
prevalence)
• 51,7% of all OPOs performed HIV NAT in all donors,
• 24% never test HIV NAT
• 10.3% only in HRDs, 12.1% selected HRDs, 1.7% only when requested
• Those that performed HIV NAT, only 36.4% the results are always
available before transplant, 6.8% never
• Average between 4-8 hours, significant number more than 24 hours
• Kidneys and liver were the most frequently transplanted organs in
HRDs.
• How many HRDs were positive?
Am J Transplant 2009; 9: 620-628

20. Lack of data: real incidence
Average risk donors (ARDs): donors with no identified risk factors.
Increase risk (IRDs): donors with identified risk factors (HRDs)
No performed NAT in ARDs
In IRDs NAT reduces the residual risk:
Intravenous drug users:residual risk for HIV with serology 0.48-2.11
Using NAT: 0.15-0.67
The highest yield NAT is for HCV infection (14.2-65.2 to 1.4-6.5)
NAT limitations: testing volume; training; competence; experience
Recipient information and follow-up (biovigilance)
Review HRDs definitions

21. Median waiting time:
liver heart lung
USA (2007) 584 days 210 days 912 days
Spain (2010) 165 days 111 days 222 days
Risk- benefit

22. Organ donor
Risk factors
No risk factors (depend on your
WL)
Conventional More than one
serology (eg, IVDA + NAT
Reject
4th generation hemodilution) Risk management
No NAT Risk management
General WL?
Reject
Special WL?

27. • What does high risk mean?: review (high, medium, low risk?)
• NAT can reduce the risk but never eliminate to zero
• Risk factors can be different in different areas or countries
(know the epidemiology, incidence and prevalence, high risk groups,
do not forget the partner)
• If you use HRDs, recipients have be tested at periodic intervals
(don’t wait until symptoms appear)
• More studies are needed to compare new test generation and
NAT.
• Incidence of potential organ donor with risk factors with positive
serology or negative with NAT positive.
•Society doesn’t accept even a very low level of risk

28. We only could investigated the risk that we know