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Australia’s top COVID-19 clinical advisory group says there is not yet enough evidence to support use of a new monoclonal antibody treatment, of which the federal government recently bought more than 7700 doses.
The drug, Sotrovimab, is an antibody treatment that can be given to people as soon as they fall sick. The hope is it can be given to people at risk of serious illness from COVID-19 – such as the elderly and the obese – when they become infected.
Interim results from a clinical trial of Sotrovimab appear to show dramatic benefits for high-risk COVID-19 patients.
On Saturday, Health Minister Greg Hunt trumpeted his government’s purchase of the drug, which he said “has been shown to dramatically reduce hospitalisation and risk of death in adults with mild to moderate COVID-19”.
However, the drug has not been approved for use in Australia by the Therapeutic Goods Administration. Final results of the company’s phase 3 trial are yet to be published.
The National COVID-19 Clinical Evidence Taskforce, which is funded by the federal government, recommends the drug should not be used to treat COVID-19 outside a clinical trial.
Taskforce director Professor Julian Elliott said there was not enough high-quality evidence to prove the drug worked.
Associate Professor Julian Elliott says the taskforce wants to see more data on the drug.Credit:Justin McManus
“Based on the fact it was an interim analysis of a single study, with relatively low numbers, the panel decided to give an only-in-research recommendation, pending the availability of more data,” he said. “We don’t base our recommendations on press releases.
“Other countries have also purchased Sotrovimab. I think the government trying to get ahead of the curve and purchasing a drug, pending review by the TGA, is reasonable.”
The government’s purchase was supported by the federal government’s science and industry technical advisory group, Mr Hunt said in a statement.
“The taskforce’s recommendation was prior to the current assessment of Sotrovimab by the TGA,” a spokesman for the Health Department said.
The European Medicines Agency and the US National Institutes of Health both list the drug as a recommended treatment.
Sotrovimab is a monoclonal antibody therapy, which means scientists select a powerful antibody from a patient and then clone it billions of times.
Those cloned antibodies can be injected into other patients, where they stick to the spike protein on the coronavirus, gumming up its mechanism and stopping it from infecting human cells.
“It works in a very similar way to how our natural antibodies work,” said Dr Krystal Evans, medical lead for COVID-19 therapeutics at the drug’s manufacturer GlaxoSmithKline Australia. “It specifically targets a spot on the coronavirus spike protein, on the receptor binding dominion … and essentially prevents the virus from entering the cell.”
Health Minister Greg Hunt.Credit:Scott McNaughton
She would not say how much the company charged the federal government for the treatment.
Interim results from the company’s phase 3 clinical trial – uploaded as a pre-print in May but not yet published in a peer-reviewed scientific journal – appear to show dramatic benefits.
The trial gave the drug to 291 patients and compared them to 292 patients given a placebo. The patients were selected as being at high risk of serious COVID-19: they were aged over 55, or had diabetes, obesity, kidney disease, heart failure or asthma.
Treatment started within five days of the patients falling sick. In the placebo group, 21 patients ended up seriously ill; only three of those treated with Sotrovimab did.
“I think the evidence is pretty convincing,” said Associate Professor Steven Tong, who heads a clinical trial of COVID-19 therapies at the Doherty Institute. “For these patients who haven’t been hospitalised yet, if you do get to them early, they seem to cut the risk of serious illness and death.”
If the drug became widely available, people with risk factors could be offered the treatment when they tested positive, he said, which would potentially significantly reduce the number of lives lost to COVID-19. “If it works as well as the clinical trial suggests it should, then absolutely.”
Liam Mannix’s Examine newsletter explains and analyses science with a rigorous focus on the evidence. Sign up to get it each week.
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