GPs expected to have ‘really important role’ in new COVID therapy

Anastasia Tsirtsakis

24/08/2021 3:40:12 PM

Federal Health Minister Greg Hunt has said sotrovimab will be available sometime this week. But uncertainties remain about how patients will access the treatment.

A scientist in a lab.
Preliminary trial results have found sotrovimab to be 79% effective in preventing hospitalisation. (Image: GSK)

Australia’s procurement of the novel monoclonal antibody (mAb) treatment has been hailed as an important milestone in the management of COVID-19 for people deemed at increased risk of developing severe disease.
Granted provisional approval by the Therapeutic Goods Administration (TGA), the Federal Government has secured more than 7700 doses, with the first shipment already onshore and expected to be available through the National Medical Stockpile (NMS) sometime this week.
Associate Professor Paul Griffin, an infectious diseases physician at the University of Queensland, told newsGP while the treatment does not override the need for widespread vaccination that it does signal ‘a big shift’ in Australia’s ability to manage the virus.
‘So far we’ve had to focus solely on prevention and supportive care, which isn’t really enough if we want to gain the upper hand,’ he said.
‘So to have a safe and effective therapy, it is going to make a big difference and mean that the impact of this virus, and obviously the outcomes on those infected, will be vastly different now that we have access to this.’
However, questions still remain over who will be given access and where it will be delivered.
So far it has been provisionally approved for people aged 12 and over, weighing at least 40 kg, who contract mild to moderate COVID-19, do not require hospitalisation or oxygen, and are at risk of developing severe COVID-19. Its use is expected to be targeted for Australians aged 55 and over who have one or more risk factors for disease progression, including diabetes, obesity, chronic kidney disease, heart failure, lung disease and moderate to severe asthma.
With up to 15% of the adults with COVID-19 estimated to fit the profile for treatment, Associate Professor Griffin said further guidance and education will need to be developed to help clinicians identify eligible patients early on.
‘There are so many comorbidities that do put people at a higher risk, which is potentially quite a large eligible pool in the population,’ he said. ‘We will have to look at how we stratify people’s risk and identify those patients who’ll get the most benefit from this medicine.’
A GlaxoSmithKline (GSK) spokesperson told newsGP the treatment is likely to be administered in a healthcare facility, but that discussions between clinicians and governments ‘to determine the exact treatment settings and to understand how an infusion will best integrate into existing pathways for COVID patients’ are still ongoing.
Meanwhile, a Department of Health spokesperson told newsGP access to sotrovimab will be made available via the NMS ‘following a request from the respective chief health officer’.
‘It will be up to states and territories to determine who will have access/prescribe this treatment; however, it is expected that given this treatment requires administration via infusion over approximately one hour, that treatment will be provided in hospital,’ the spokesperson said.

Infectious diseases physician Associate Professor Paul Griffin says sotrovimab has the potential to be ‘a game changer’ in terms of how Australia manages the pandemic. (Image: GSK)

But even though the finer details are still being confirmed, Associate Professor Griffin said health authorities are assessing ways to avoid reliance on hospitals, where possible, with a focus on community settings instead.
‘A lot of jurisdictions have Hospital in the Home models, where positive cases are being managed in their own homes,’ he said.
And even if is determined that the administration of sotrovimab will be restricted to hospitals, Associate Professor Griffin says GPs will still have ‘a really important role in this therapy’.
‘We’re still not exactly sure how it’s going to work, and it might be slightly different in different areas, depending on how the health system works,’ he said.
‘But we will absolutely need GPs – both from identifying people’s risk factors and maybe being the first port of call in terms of diagnosing people as well because we know it needs to be given fairly early on.
‘So GPs will have a vital role.’
The recommended treatment course of sotrovimab is a single 500 mg dose, administered as an intravenous infusion over 30 minutes, with patients monitored both during and one hour after the treatment cycle.
Preliminary results from phase 3 of the COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early (COMET-ICE), involving 1057 people, found sotrovimab was 79% effective in preventing hospitalisation or death by day 29.
Six patients from the sotrovimab arm were hospitalised (1%) compared to 30 patients in the placebo arm (6%). However, the research notes at least half of the six patients hospitalised after receiving the treatment may have been due to ‘reasons other than progression of COVID-19’.
The most common adverse reactions were mild-to-moderate diarrhoea (2%) and rash (1%).
To be most effective, it is recommended the treatment be administered within five days of onset of symptoms.
Unlike vaccines that work to train the immune system to produce antibodies, mAb treatments bypass this process. Produced or cloned from immune cells in a lab to target specific viral proteins, mAbs bind to an epitope on SARS-CoV-2 to stop it from entering host cells and to help fight off already infected ones.
‘It is something that, if used appropriately, can make a big difference in those at greatest risk,’ Associate Professor Griffin said.
As it stands, sotrovimab’s efficacy and safety in those who have received a COVID-19 vaccine at any time prior to its administration has not been established.
Australia’s COVID-19 Clinical Evidence Taskforce (the Taskforce) maintains that sotrovimab should not be used to treat COVID-19 outside of clinical trials, but that could soon change.
‘The Taskforce recommendation on the use of sotrovimab is currently under review and is expected to be completed by the end of the week,’ a Taskforce spokesperson told newsGP.
Sotrovimab is the first mAb treatment approved for COVID-19 in Australia, with the TGA having since granted a provisional determination for two additional mAb treatments for people who contract COVID-19 and are at risk of developing severe disease – regdanvimab and the combined therapy casirivimab and imdevimab.
Associate Professor Griffin says as well as sotrovimab allowing healthcare professionals to modify the trajectory of disease, it has the secondary benefit of reducing the burden on the healthcare system.
‘Something that frees up some of those resources is potentially a game changer in terms of how we manage this pandemic,’ he said.
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comorbidities COVID-19 mAbs monoclonal antibody treatment severe disease sotrovimab

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Dominic Barnes   25/08/2021 7:55:53 AM

Do we know the time it took for TGA listing, from dossier submission date to approval date?

Dr Andrew Robert Jackson   25/08/2021 9:40:24 AM

Plenty of general practices including mine are very skilled at giving intravenous infusions, particular ones that have a fairly rapid infusion time and a short period of observation thereafter. The only hitch'll be inviting someone with active COVID-19 infection into your practice premises and good luck with that.

Dr Susan Linda Beutum   25/08/2021 10:48:18 AM

Would it be wiser to set up / refer to specific respiratory clinics to be giving sotrovimab to avoid poeple with covid entering a general practices? There are a few respiratory clinics where the appropriate PPE is worn and there would be less risk to the general practice community patients . I cannot imagine giving an IV drug in the car park safely

Dr Bekah R   25/08/2021 8:57:43 PM

Do you mean turn general practice to covid wards?! I can't believe they suggested that!