HIV residual risk in Canada for apheresis source plasma donation without deferral for men who have sex with men

Abstract

Background and Objectives In Canada, men having sex with men (MSM) are deferred for 3 months from last sexual contact to reduce human immunodeficiency virus (HIV) risk to recipients. The aim of this paper was to model the Canadian residual risk of HIV‐positive source plasma incorporating pathogen inactivation (PI) under no MSM deferral scenarios for apheresis plasma donations. Materials and Methods A combined Bayesian network (BN) and Monte Carlo approach were implemented to estimate the HIV residual risk under 3‐month deferral compared with no deferral without quarantine scenarios for MSM donors. Models involve the stochastic generation of donation and its infection status based on its corresponding simulated donor profile. Viral load reduction conferred by PI used by source plasma fractionators was simulated. Model parameters were derived from Héma‐Québec and Canadian Blood Services data, viral loads in a large sample of HIV‐positive US blood donors, CSL Behring documentation and from published data. Results In the most likely scenario for the 3‐month deferral model, there were 2.71 positive donations per 1,000,000 donations (95% confidence interval [CI] 2.63–2.78). For the no‐deferral model, there were 3.01 positive donations per 1,000,000 donations (95% CI 2.94–3.09). For both scenarios, the risk of having an infectious pool was 0 in 300,000 pools (95% CI 0–0.0000123) after consideration of PI. Conclusion Based on simulation results, there would be a negligible HIV residual risk associated with the removal of a time‐based MSM deferral without quarantine for source plasma incorporating PI.

Risk of transfusion‐related acute lung injury and human immunodeficiency virus associated with donations from trans donors in Quebec, Canada

“…Trans female donors were assumed to have sexual behaviours similar to those of MSM in the last 3 months. Therefore, HIV incidence for trans female donors was assumed to be the same as that for MSM plasma donors who did not comply with the current 3‐month deferral, as reported by Aubé et al [11]. Uncertainty about the difference in HIV incidence for trans female donors versus MSM donors was addressed in the scenarios (see further below).…”

“…For donations made outside the window period, the risk of HIV infection was calculated as follows, based on the prevalence of HIV among trans female donors: The prevalence of HIV among trans female donors was derived from the results of Aubé et al for non‐compliant MSM plasma donors [11].…”

“…The prevalence of HIV among trans female donors was derived from the results of Aubé et al for non-compliant MSM plasma donors [11].…”

Validation of new, gender‐neutral questions on recent sexual behaviors among plasma donors and men who have sex with men

“…Source plasma was considered a prudent initial step for transitioning to a gender-neutral questionnaire given its negligible risk of human immunodeficiency virus (HIV) transmission. 7 Gender-neutral questions are already used in countries such as the United Kingdom, where donors are asked "if they had a new sexual partner or more than one sexual partner in the last 3 months." 8 Such compound question (i.e., >1 item) is generally considered suboptimal for reading comprehension and would typically be broken down into separate questions.…”

Staff perspectives on barriers and enablers to implementing alternative source plasma eligibility criteria for gay, bisexual, and other men who have sex with men

“…[2][3][4][5] Several countries have now eased restrictions from lifetime bans to progressively shorter time-based deferrals 2 without compromising safety. 6,7 Calls for more inclusive and equitable criteria, 3,7 and evidence suggesting deferral periods are no longer necessary, 7,8 have led Canadian Blood Services (CBS) to explore further changes to blood and plasma policies. In May 2021, CBS submitted a proposal to Health Canada, the regulatory body, to change the criteria for source plasma donation 9 given the low risk of transmission of blood-borne infections in plasma-derived products.…”