1. A new evaluation of the risk of transfusion-transmitted HIV prevented by a 12-month deferral before donation for men who have sex with men
Josiane Pillonel, Aurélie Santos, Florence Lot, Christophe Martinaud,
Rachid Djoudi, Syria Laperche, Marie Jauffret-Roustide, Bruno Danic
for the “blood donor epidemiological surveillance study group”.
25th Regional Congress of the ISBT, London 2015

2. Background
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In France, Men who have Sex with Men (MSM) are permanently excluded from blood donation
This permanent exclusion is felt to be discriminatory and outdated
In addition, this criterion is not fully respected since some MSM do not report they have had sex with men
According to the European court of justice, this permanent exclusion of MSM is considered to be disproportionate compared to the risk of HIV transmission
 This permanent exclusion of MSM needs to be changed

3. Objectives
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– To estimate the excess risk of HIV transmission by transfusion associated with the lack of compliance of MSM with the current policy and to assess the rate of non-compliance
– To assess the impact on the risk of HIV transmission by transfusion of a new strategy in which men would be deferred for 12 months after their last sexual contact with a man

4. What is the current residual risk of transmitting HIV by transfusion in France (2011-2013)?
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HIV Residual Risk = HIV Incidence Rate among repeat blood donors x (Window Period/365)
0.89
(0.58 – 1.34)
1/3,450,000 donations
(0 - 1/11,000,000)
Incidence rate
per 105 D-Y
(95% CI)
HIV Residual Risk 24
HIV incidents
cases
2011 to 2013
2,710,846
Number of
Donor-
Years 12
Window period
(in days)
 This corresponds to less than one donation infected with HIV per year in France

5. Fraction of the current HIV residual risk attributed to MSM France, 2011-2013
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Of the 24 HIV incident cases observed during the study period: 22 men, 2 women During the post-donation medical interview, the mode of contamination was identified:
- 15 MSM
- 9 heterosexuals (7 men, 2 women)
Despite the permanent exclusion of MSM: two third (15/24) of the HIV residual risk is attributable to MSM who do not comply with the permanent deferral
Therefore, if all MSM had abstained from donating blood during the study period, the risk would have been 1 in 9,000,000 donations, a 2.6 fold reduction in the residual risk (1/3,450,000).

6. Assessment of non-compliance of MSM with the permanent deferral for MSM donors found to be HIV positive - France,
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Non-compliance rate = # of HIV infections among MSM new donors .
(first time donors) # of MSM living with HIV, but undiagnosed
= (on average each year between ) .
9200*
 MSM non-compliance rate for new donors = 0.054% [plausible interval: 0.045%-0.064%]
Non-compliance rate = # of new HIV infections among MSM repeat donors
(repeat donors) # of new HIV infections among MSM not diagnosed during the same year
= (on average each year during )
2220 (3320 HIV new infections in MSM** – 1100 diagnosed*** in the same year)
 MSM non-compliance rate for repeat donors = 0.32% [plausible interval: 0.29%-0.36%]
*Supervie et al. AIDS **Le Vu et al. The Lancet infect Dis *** Cazein C. et al BEH 2015

7. Assessment of non-compliance of MSM with the permanent deferral calculated over the entire male blood donor population ( )
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Best case scenario: Non-compliance of HIV negative MSM = Non-compliance of HIV positive MSM
Worst case scenario: MSM give blood at the rate of the male general population
Scenarios
New donors
Repeat donors
All donors
Best case
Non-compliance rate of HIV+ MSM (a)
0.054%
0.32% -
Number of HIV negative MSM (b)
794,000
Number of non compliant MSM (c = a*b)
429
2,541
2,970
Number of donors (average ) (d)
175,000
655,000
830,000
rate of non-compliant donors (c/d)
0.25%
0.39%
0.36%
Worst case
Proportion of male blood donors (18-70 years) (a’)
3.92%
Number of non compliant MSM (c’ = a’*b)
31,123
rate of non-compliant donors (c’/d)
3.75%
 Rate of non-compliance is in between 0.36% and 3.75%

8. Non-compliance in other countries
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Surveys among blood donor sample  denominator of non-compliance rate = # of male donors
Author
Journal
Year
Country
Study period N
% of non-compliance
lifetime
< 12 months
Sanchez
Transfusion
2005 US
1998
25,168 men
2.4%
0.4%
Goldman
2011
Canada
2008
18,108 men
1.4% in FTD
0.5% in FTD
1.0% in RD
0.1% in RD
Seed
Vox Sang
2014
Australia
14,473 men -
0.23%
0.16% in FTD
0.24% in RD
FTD = first time donors, RD = repeat donors
Non-compliance to lifetime exclusion in France : 0.36% to 3.75%

9. Impact of a new strategy in which men would be deferred for 12 months after the last sexual contact with a man ( )
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– If compliance to the new strategy was perfect, the HIV residual risk attributable to MSM would be zero (1 year > duration of the silent window period)
 HIV residual risk = 1/9,000,000
– Using published estimates of non-compliance among repeat donors: 0.1%* to 0.4%**
The new strategy would result in an overall HIV residual risk :
from 1 in 6,000,000 donations (with 0.1%)  1.7 times lower than the current risk
to 1 in 3,300,000 donations (with 0.4%)  close to the current risk
* Goldman et al, Transfusion ** Sanchez et al, Transfusion 2005

10. Sociological survey among blood donors found HIV positive
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As compliance is a key parameter, we decided to implement a sociological study among donors found to be HIV positive at the time of donation
Objective: To explore knowledge, attitudes and motivations of donors found HIV positive.
Methods: Qualitative interviews among 30 donors and ethnographic observations in blood donation units
This in-depth qualitative approach of the situation of donors found to be HIV positive will allow us to understand the social context of blood donation and elements leading to non- compliance
This should improve the pre-donation medical interview and, therefore, the blood safety
Results will be available at the beginning of 2016

11. Conclusion
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First study to assess the excess of HIV risk linked to the lack of compliance of MSM: 2/3 of the current risk is attributed to MSM
 this point raises the question of changing the current permanent deferral policy for MSM
A change from lifetime exclusion of MSM to a 12-month deferral does not seem to increase the risk of transfusion-transmitted HIV in France.
If, as already reported, compliance is better for a 12-month deferral than lifetime exclusion, then the number of HIV incident infections and HIV residual risk should decrease.

12. The blood donor epidemiological surveillance study group:
Acknowledgements
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The blood donor epidemiological surveillance study group:
Georges Andreu, Laurent Aostin, Frédéric Biget, Claude Chuteau, Bruno Danic, Gérald Daurat, Arlette Delbosc, Rachid Djoudi, Pierre Gallian, Syria Laperche, Marie-Françoise Leconte des Floris, Caroline Lefort, Claude Maugat, Nadra Ounnoughene, Josiane Pillonel, Elodie Pouchol, Céline Roche, Magalie Sillam, Pierre Tiberghien, Geneviève Woimant