Plasma pathway

The Therapeutic Goods Administration (TGA) has approved a new ‘plasma pathway’ approach for Australian Red Cross Lifeblood to collect plasma donations for the manufacture of plasma medicines. Plasma is the pale yellow fluid part in human blood.

This approach removes most sexual activity wait times for plasma donations for the manufacture of plasma medicines. This means that many people, including gay or bisexual men, and anyone taking PrEP (a medication that prevents HIV) may become eligible to donate plasma.

WHY IS THIS CHANGE TAKING PLACE?

Demand for plasma is at a record high. Lifeblood has underlined that Australia has one of the safest blood supplies in the world – and the safety of blood and plasma products for patients will always be their top priority. They are aware that sexual activity exclusions have contributed to stigma and caused pain and frustration in some groups. So, Lifeblood has considered the alternatives carefully and proposed donation options that allow as many people as possible to donate while maintaining the safety of the blood supply.

SAFETY

HFA has consulted Lifeblood and the Australian Haemophilia Centre Directors’ Organisation (AHCDO) about the safety of the plasma pathway approach for people with bleeding disorders.

Lifeblood has confirmed that there will be no change to the HIV risk in plasma-derived treatment products with this approach because:

Lifeblood tests every blood and plasma donation for HIV, hepatitis B and hepatitis C.
There are multiple viral inactivation processes during the manufacture of these treatment products.

See the detailed Lifeblood responses below.

AHCDO is aware of and supportive of the proposed plasma pathway changes and confident that the infectious diseases and public health experts involved will progress the changes safely.

WHEN WILL THIS CHANGE TAKE PLACE?

Lifeblood is currently working with CSL Behring and the National Blood Authority on a timeline to start collecting plasma donations using the plasma pathway approach in 2025.

CSL Behring is the company in Australia that processes plasma from Lifeblood donations into medications for patients.

Visit the Lifeblood website for more information on the plasma pathway.

FAQS

Bleeding disorders are health conditions that occur when the blood does not clot properly and include haemophilia, von Willebrand disease, rare clotting factor deficiencies, inherited platelet disorders and other rare bleeding disorders.

What ARE plasma-derived medicines?

Plasma is the pale yellow fluid part in human blood.

Plasma can be made into 18 different plasma-derived medicines that help some people with bleeding disorders and people experiencing trauma, burns, cancer and blood diseases.

Some people with bleeding disorders have treatment with a type of medicine manufactured from plasma called a plasma-derived factor concentrate. Others have treatment with products that are not made from human blood, including recombinant factor concentrate and non-factor products.

Some plasma-derived factor concentrates are manufactured in Australia from Lifeblood plasma donations and include Biostate® (factor VIII[8]/VWF) and MonoFIX® (factor IX[9]).

Some plasma-derived products are manufactured overseas from plasma collected overseas and imported into Australia, including the bypassing agent FEIBA®, factor XI(9) and factor XIII(13) plasma-derived factor concentrates and fibrinogen concentrates. Products manufactured overseas are not affected by these changes.

Find out more about Australia’s supply of plasma-derived blood products (National Blood Authority).

What ARE NOT plasma-derived treatments?

These products are not made from human blood and are not affected by these changes:

Recombinant clotting factor concentrates – standard and extended half-life (EHL)
Recombinant bypassing agents, eg NovoSeven®
Non-factor products, eg Hemlibra®
Gene therapy
Tranexamic acid
Desmopressin (DDAVP)

Fresh blood treatments, including fresh frozen plasma and cryoprecipitate, are not affected by the plasma pathway changes.

Speak to your specialist treating doctor if you have any questions about your treatment product.

What are current safety approaches?

Lifeblood donors are screened with a series of questions to see if they are eligible to donate, including questions about sexual activity.

All Lifeblood plasma donations are tested for infections such as HIV, hepatitis B and C.

When they are manufactured at CSL Behring, plasma concentrates undergo several safety processes, including testing multiple times and virus inactivation.

What is different with the ‘plasma pathway’?

The plasma pathway will:

Allow anyone to donate plasma regardless of their sexual activity, as long as they meet all other eligibility rules.

Not permit people who have sexual contact with someone known to have HIV, hepatitis B or C, or HTLV to donate for 3 months or people who have these infections.

What is NOT changing?

Other screening questions for Lifeblood donors

Testing of Lifeblood donations for infectious diseases

Safety processes during manufacture at CSL Behring.

LIFEBLOOD RESPONSES

Lifeblood answered HFA’s specific questions about the plasma pathway approach.

HFA: Will there be any change to the Lifeblood blood testing process with the proposed plasma pathway approach, ie that it takes place as a first step after donation?

Lifeblood: The safety of blood and plasma products for patients will always be our number one priority. Lifeblood performs very sensitive testing for the presence of HIV, hepatitis B and hepatitis C on every blood and plasma donation and this testing requirement is not changing.

CSL Behring has expanded the in-process testing that they perform to include testing for hepatitis A and Parvovirus B19.

HFA: What are the implications for HIV risk with the proposed plasma pathway changes?

Lifeblood: Currently the chance that a blood component or plasma product will pass on HIV, hepatitis C or hepatitis B infection is extremely low, less than 1 in 1 million, and modelling performed independently by both Lifeblood and CSL Behring has shown that the plasma pathway does not change this risk.

The combination of very sensitive testing for HIV performed by Lifeblood and the pathogen inactivation processing steps performed by CSL Behring as part of the manufacture of plasma medicines, means that there is no change in the risk profile for HIV for plasma medicines.

Pathogen inactivation involves additional processing steps, for example, heat treatment to inactivate or kill viruses and viral filters as precision sieves to remove viruses, thereby effectively reducing the risk of an infection such as HIV being passed on to a patient.

Since CSL Behring introduced more intensive heat treatment (80oC for 72 hours) of plasma medicines in the early 1990s, there have not been any confirmed reports of transmission of HIV, hepatitis B or hepatitis C from any locally produced plasma medicine.

HFA: Why is Lifeblood confident that HIV risk will not increase when the plasma pathway changes are implemented?

Lifeblood: Lifeblood and CSL Behring both independently completed a risk assessment of the plasma pathway which concluded that there is no change in the risk profile for HIV for plasma medicines. A donation must test negative for HIV before it is released and with the additional pathogen inactivation that is sufficient to prevent HIV transmission. The risk assessments were also independently assessed and accepted by the Therapeutic Goods Administration.