HIV residual risk in Canada under a three‐month deferral for men who have sex with men

Abstract

Background and objectives In Canada, the deferral for men who have sex with men (MSM) was decreased from a permanent deferral to a 5‐year then a 12‐month deferral. Current HIV testing can detect an HIV infection in donated blood within 2 weeks of exposure; thus, a 12‐month deferral may be unnecessarily restrictive. We aimed to estimate the residual risk of HIV if the deferral were further decreased to 3 months. Materials and methods Using a deterministic model with stochastic Monte Carlo simulation, residual risk of HIV was the sum of testing error, assay sensitivity and window‐period risks. Data inputs were estimated from donor surveillance, donor surveys and published data. Residual risk was modelled at baseline and using three scenarios: (1) most likely – non‐compliance, HIV prevalence and incidence rates of MSM are unchanged; (2) optimistic – non‐compliance improves by 50%; and (3) pessimistic ‐ non‐compliance, HIV prevalence and incidence rates of MSM all double. Results HIV residual risk at baseline was 1 in 36·0 million donations (95% CI 1 in 1 504 907 million, 10·5 million); in the most likely scenario 1 in 34·2 million (1 in 225 534 million, 8·7 million); in the optimistic scenario 1 in 36·0 million (1 in 282 618 million, 9·5 million); in the pessimistic scenario 1 in 16·7 million (1 in 39 469 million, 6·0 million). All confidence intervals overlapped. Conclusion With very low modelled risk under a 12‐month deferral, the additional risk with a 3‐month deferral is very low. This is true even with a pessimistic scenario.

Gender‐neutral donor deferral policies: experience in Argentina implementing individual risk‐assessment policies

“…Even though our data are in agreement with the mentioned reports [2,[4][5]7,8], local epidemiological context is complex and different. In this sense, during recent years, there has been an increase in the incidence of STI.…”

“…Moreover, a study by Suligoi et al [5] in 2013 demonstrated that after the change of donor screening criteria introduced in Italy in 2001, no significant increase in the proportion of MSM compared to heterosexuals was observed among HIV antibody-positive blood donors. Modelling studies performed in the US, Canada, UK and France evaluating several scenarios predicted negligible risk increments (less than 1 in 1 million units) when changing to a 12-month deferral period [2,8].…”

“…In December 2015, the U.S. Food and Drug Administration (FDA) released revised guidelines regarding deferral criteria for MSM blood donors, changing its policy from indefinite deferral to a 12-month postponement since the last sexual contact with another man [6]. In this sense, time-based deferrals have been already reduced from 12 months to 4 in the Netherlands, Denmark and France and to 3 months in England, Scotland, Wales and Canada [7,8].…”

The evolving blood donor deferral policy for men who have sex with men: impact on the risk of HIV transmission by transfusion in France

“…23 In Canada, 3-month deferral was introduced on June 3, 2019, after a similar analysis highlighted no increased risk to the safety of blood products intended for transfusion. 24,25 In S2, to estimate the number of additional MSM donors compliant with the selection criterion, we used the proportion of MSM with only one sexual partner in the previous 6 months reported in ERAS 2017 (30.4%). 10,11 This percentage would likely be higher for a shorter duration of 4 months, which would suggest an underestimation of the number of compliant MSM.…”

Men having sex with men and blood donation: is there a game changer on the horizon?

“…7 That same year, Canada also changed from a 12-month to a 3-month deferral, again based on a favorable risk assessment. 8 Although the data have not yet been published, it appears that this policy change has had, once again, no measurable impact on the prevalence of HIV in the donor population of these two countries. The predictions made by the Pillonel model are therefore in agreement with these preliminary observations.…”