More people now able to donate plasma

Filip Vukasin

9/06/2023 3:45:19 PM

TGA approves ‘plasma pathway’, which is expected to see an increase of 14,000 donations per year and allows MSM to donate.

A man using his phone while donating blood.
Lifeblood expect to see an increase of at least 14,000 plasma donations per year as a result of the new pathway.

In a world first, Australia will allow anyone currently deferred from donating plasma due to sexual risk factors to do so via a ‘plasma pathway’.
This means men who have sex with men (MSM) and those on pre-exposure prophylaxis (PrEP) for HIV will be able to donate plasma for the first time.
The Therapeutic Goods Administration (TGA) made the announcement on 30 May, with the Federal Assistant Health and Aged Care Minister Ged Kearney welcoming the move.
‘This decision by the TGA is a welcomed step in enabling more people to donate plasma, including gay and bisexual men,’ she said.
‘It is an important decision in providing life-saving plasma to people who need it and one based on the best of medical evidence.’
Plasma can be used for a range of medical conditions, including severe burns, kidney and liver disease, haemophilia, tetanus, chicken pox and immune deficiencies.
Professor Iain Gosbell, Lifeblood National Donor and Product Safety Specialist, told newsGP the organisation is excited to have received the TGA’s approval for the plasma pathway.
‘It was important for us to propose a donation option that’s available to as many people as possible,’ he said.
However, Professor Gosbell also said it may take several months to obtain approval from state and federal governments and CSL Behring, the company that processes plasma into medicines for patients.
‘This is the first step, and it is a world leading one,’ Professor Gosbell said.
‘We know that people want change on this rule, and we believe that the plasma pathway is an inclusive option for many Australians who are currently unable to donate.’
Rodney Croome, Vice President of Just Equal, which is lobbying for MSM to be able to donate whole blood, told newsGP that other countries have trialled a similar plasma pathway but eventually settled on allowing MSM to donate whole blood.
‘Canada and Israel both trialled allowing MSM to give plasma but not whole blood,’ he said.
‘Both countries abandoned their trials and moved on to allowing whole blood donation by MSM and the adoption of individual risk assessment for all donors.’
Mr Croome says a Canadian study found many gay participants felt a plasma-only policy ultimately made them feel like second-class donors by creating a two-tier system and equated the plasma pathway and blood donation to civil unions and marriage equality.
Professor Gosbell says Israel and Canada’s approaches differed to Australia’s in two ways.
‘They required the plasma donation to be initially quarantined, with its release dependent on the donor returning and testing HIV negative on a repeat blood test 3–4 months after the donation,’ he said.
‘In addition, these pathways were less inclusive, for example individuals taking PrEP were deferred.
‘The Australian evidence shows that a quarantine and retest approach is not required from a safety perspective, leads to wastage if the donor does not return and has considerable logistical complexity and is not the intended pathway in this country.
‘Australia would be the first country to allow men on PrEP to donate, which could impact up to 57,000 people, based on notifications of PrEP use.’
Professor Gosbell says Lifeblood expect to see an increase of at least 14,000 plasma donations per year from newly eligible donors.
‘We know that people are really keen to donate, so we hope the numbers would be much greater,’ he said.
‘We do know that people have wanted to see change with this rule, so we are also expecting to see others come forward and donate in response to this change.’
For Mr Croome, however, the plasma pathway represents a dead end.
‘It neither increases the supply of safe whole blood, nor removes discrimination against MSM in blood donation,’ he said.
‘The solution to both these problems is the assessment of each donor’s individual risk, regardless of whether they are gay or heterosexual.
‘This is the policy that has been adopted in an increasing number of countries including the UK, the US, the Netherlands, Canada, France, Germany, and Israel.’

plasma-pathway-article.jpgUnder the new pathway, people on pre-exposure prophylaxis for HIV will be able to donate plasma.
Mr Croome says MSM donate blood at about the same levels of the general population, which is approximately 3.5%. He says if 4.5% of men are MSM according to international census figures, allowing them to donate whole blood would provide approximately 13,500 new donors.
‘54,000 new donations and 25,500 more litres of blood per year,’ he said.
‘Given Lifeblood says each donation saves three lives, that’s 162,500 lives saved.’
But according to Professor Gosbell, allowing individual risk assessment has had little impact in other countries.
‘Experience from international countries that have implemented an individual risk assessment have reported an overall modest change in donor numbers, with either a small overall increase or a small overall decrease in the size of the donor panel,’ he said.
Professor Gosbell says the primary goal of changing blood rules is to allow as many people as possible the opportunity to donate blood, rather than boost blood stocks.
He adds that while the plasma pathway is currently the priority, Lifeblood is undertaking research to assess whether there is an approach for other donation types that could work safely in Australia.
‘Because not even the best available testing can pick up a new HIV infection, we ask people who are at a higher risk of exposure to HIV to wait three months since their last sexual activity to donate blood,’ Professor Gosbell said.
‘We look at Australian research and HIV surveillance data, such as that conducted by the Kirby Institute in New South Wales, to ensure our rules are evidence-based in the Australian context.’
According to the Kirby Institute, there were 552 HIV notifications with a first ever diagnosis in Australia in 2021, a 48% decline in notifications since 2012 and a 38% decline since 2019.
Of the HIV notifications in 2021, 68% were for MSM and injection drug use.
Professor Gosbell says preliminary modelling shows individual risk assessment is associated with a slight increase ‘in the already very small risk’ of being infected with HIV from once in 31 years, to once in about 18 years.
‘We need to understand community attitude to this change in risk,’ he said. ‘[Including] calculating the impact on the size of the donor panel and losing currently eligible donors and how to reduce those.
‘We also know HIV rates are continuing to decrease, and we are seeing PrEP is contributing to those decreases significantly.
‘For these reasons and others, we need to complete the research work first before making any recommendations about an approach for whole blood donations. We are committed to looking at what approach might work for Australia.’
According to the Kirby Institute’s Transfusion-transmissible Infections in Australia 2022 Report, the most common infection picked up at donation is hepatitis B virus. HIV is the least common, with only two donors testing positive in 2021.
No transfusion-transmitted infections were reported in Australia in 2021.
Mr Croome thinks it is inevitable that Lifeblood will allow MSM to donate whole blood.
‘The question is how long it will take, how many lives will be jeopardised by Lifeblood not taking our blood, and how much more stigma gay and bisexual men need to endure,’ he said.
‘Lifeblood has said it will conduct a review of individual risk assessment but there will be no result for two years. That’s too long.
‘The evidence is clear already. It’s time to drop the gay ban and assess all donors equally.’
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