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

Background 2/12 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with Men (MSM) are permanently excluded from blood donation This permanent exclusion is felt to be discriminatory and outdated In addition, this criterion is not fully respected since some MSM do not report they have had sex with men According to the European court of justice, this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

Objectives 3/12 – 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

What is the current residual risk of transmitting HIV by transfusion in France (2011-2013)? 4/12 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

Fraction of the current HIV residual risk attributed to MSM France, 2011-2013 5/12 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).

Assessment of non-compliance of MSM with the permanent deferral for MSM donors found to be HIV positive - France, 2011-2013 6/12 Non-compliance rate = # of HIV infections among MSM new donors . (first time donors) # of MSM living with HIV, but undiagnosed = 5 (on average each year between 2011-2013) . 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 = 7 (on average each year during 2011-2013) . 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 2014 **Le Vu et al. The Lancet infect Dis 2010 *** Cazein C. et al BEH 2015

Assessment of non-compliance of MSM with the permanent deferral calculated over the entire male blood donor population (2011-2013) 7/12 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 2011-2013) (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%

Non-compliance in other countries 8/12 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 2012-13 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 2011-13: 0.36% to 3.75%

Impact of a new strategy in which men would be deferred for 12 months after the last sexual contact with a man (2011-2013) 9/12 – 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 2011 ** Sanchez et al, Transfusion 2005

Sociological survey among blood donors found HIV positive 10/12 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

Conclusion 11/12 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.

The blood donor epidemiological surveillance study group: Acknowledgements 12/12 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