Blood donation: moving toward greater inclusion of men who have sex with men

Following risk assessments of two scenarios for expanding blood donation eligibility to men who have sex with men, conducted by Santé publique France and published today, the Minister of Health has announced her decision.

The Minister has come out in favor of reducing the period of abstinence from sex between men prior to donation from 12 months to 4 months. As a reminder, in July 2016, men who have sex with men (MSM)—who had been excluded from donating blood since 1983 due to a high risk of HIV infection—were authorized to donate blood provided they had not had sex with another man in the 12 months prior to donation.

2018: Evaluation of the July 2016 decision to allow MSM to donate blood

In November 2018, Santé publique France published the results of the Complidon survey, conducted among blood donors, showing that the eligibility criteria for blood donation were largely followed, but that in rare cases they might not be met when they were not understood or accepted. In particular, 0.73% of male blood donors reported having had sex with men in the past 12 months without disclosing this during their last donation. Despite this, and according to epidemiological surveillance data on blood donors analyzed by SpFrance, opening blood donation to MSM who had not had sex with men in the past year did not increase the risk of HIV transmission through transfusion. The residual risk is estimated at one undetected HIV-positive donation out of 6,380,000 donations between July 10, 2016, and December 31, 2017, which corresponds to approximately one HIV-positive donation every two years. This theoretical risk remains extremely low.

These results provide new evidence for public health authorities to consider a broader opening of blood donation to MSM. Two scenarios have been considered by health authorities:

  • Opening blood donation to men who have not had sex with men in the 4 months prior to donation (reducing the current 12-month period to 4 months);

  • Opening blood donation to MSM who have had a single partner in the 4 months prior to donation (the same criterion as for other donors).

The goal was to determine the residual risk of HIV transmission associated with these two scenarios.

2019: Risk analyses of two scenarios for broader access to blood donation for MSM

The report “Evolution of blood donor selection criteria regarding men who have sex with men: impact on the risk of HIV transmission through transfusion,” published by Santé publique France, now provides estimates of this residual risk.

Scenario 1: Opening blood donation to men who have not had sex with men in the 4 months prior to donation

In this scenario, the residual HIV risk was estimated at one undetected HIV-positive donation out of 6,300,000 donations, which is therefore no different from the current risk.
The sensitivity analysis showed that this estimate was robust and remained the same even under the maximum assumption where the number of additional MSM donors and the incidence of HIV among these donors were increased by 50%.

Scenario 2: Opening blood donation to MSM who have had a single partner in the 4 months prior to donation

For this scenario, which would allow MSM to donate blood under the same criteria as other donors, the residual HIV risk was estimated at 1 undetected HIV-positive donation per 4,300,000 donations, or 1.5 times the current residual risk.
A sensitivity analysis, identical to the one conducted for Scenario 1, showed that this estimate was less robust than for the first scenario, with a residual risk reaching a maximum of 1 in 3 million donations—twice the current risk.
This risk remains very low, however, as it corresponds to approximately one undetected HIV-positive donation per year.

What is residual transfusion risk?

The safety of blood products relies on two essential steps: the screening of blood donors prior to donation and the biological qualification of the donation.
The first step ensures that individuals with risk factors for bloodborne infections are excluded from donating.
The second step ensures that any infected donation is excluded from therapeutic use. Biological screening is performed through systematic testing of every blood donation for infections related to HIV, HCV, HBV, or Treponema pallidum (the causative agent of syphilis), or for HTLV in donations from first-time donors. However, there is a delay of several days between infection and the point at which markers of infection become detectable by available biological tests. This “window period” constitutes the primary component of residual transfusion risk.

Learn more

rapport/synthèse

22 January 2020

Changes in blood donor eligibility criteria regarding men who have sex with men: impact on the risk of HIV transmission through blood transfusion