Lifeblood sexual activity and PrEP deferrals

On 25 May 2023 the Therapeutic Goods Administration (TGA) approved applications submitted by Australian Red Cross Lifeblood (Lifeblood) to remove most of the sexual activity ineligibility criteria for plasma donors used for fractionated products only. Lifeblood refers to this approach as ‘the plasma pathway’.

In Australia, there is currently a 3-month deferral period for Lifeblood donors whose sexual practices put them at increased risk of acquiring infectious diseases that can be transmitted by blood, cells, or tissues. This deferral period is applied to donor groups with sexual activity-based risk factors, including sex work and male-to-male sex.

Lifeblood also applied to remove the 3-month donor deferral period for plasma donors receiving Pre-exposure Prophylaxis treatment (PrEP) to prevent HIV in higher risk individuals.

The Lifeblood applications were evaluated by specialist scientific and medical evaluators within the TGA.

The TGA’s decision was made based on the evidence provided in the Lifeblood submissions and the scientific, epidemiological, and clinical assessment conducted by the TGA. The Lifeblood submissions and TGA assessment determined that recipient safety remains within accepted risk tolerance parameters and ensures the ongoing safety of the Australian blood supply.

The implementation of any changes based on this approval will require further actions from CSL Behring (who process plasma into medication for patients) and state and territory governments, who have legal responsibility for the donor questionnaire in their jurisdictions. Further information about the timeframe for the implementation of changes should be referred to Lifeblood.

Further information can be found on the Lifeblood website.

The existing donor deferral periods for transfusible components such as whole blood are unaffected by this change to the deferral period for plasma donors. The scope of any change in donor deferrals resulting from this submission is restricted to Lifeblood and does not apply to other sponsors/products.

Sexual activities covered by the change in eligibility criteria

The Lifeblood submission proposed to allow plasma for fractionation donation for anyone reporting the following activities in the past 3 months:

• for male donors: male-to-male sex
• for female donors: sex with a man who has ever had sex with a man
• for transgender donors: sexual contact with a male
• sex work
• sexual contact with a sex worker (male or female)
• overseas sexual contact with a resident of a HIV high prevalence country
• sexual contact with a new partner from a HIV high prevalence country
• sexual contact with an injecting drug user (current or past)

Additional donor groups

Plasma donors currently receiving pre-exposure prophylaxis HIV prevention (PrEP) treatment will also be able to donate without a deferral period, subject to meeting other Lifeblood eligibility requirements.

Exceptions to this change in deferral

• Donors who have sexual contact with a partner known to be infected with a blood-borne virus (HIV, hepatitis B virus, hepatitis C virus or human T-lymphotropic virus) are outside the scope of the proposal and the deferral period for those donors remains unchanged.