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GPs urged to not dismiss molnupiravir entirely


Jolyon Attwooll


12/12/2022 5:17:19 PM

While guidelines say the drug should be only prescribed as a ‘last resort’, there are concerns this could deter GPs from prescribing the treatment altogether.

Anita Munoz, Michael Kidd, Brett Sutton
Dr Anita Muñoz, Deputy Chief Medical Officer Professor Michael Kidd and Victoria’s Chief Health Officer, Professor Brett Sutton, have come out in support of molnupiravir.

This month, the National Clinical Evidence Taskforce changed its guidelines for the use of molnupiravir (sold as Lagevrio) against COVID-19, citing ‘high certainty evidence’ the treatment does not reduce hospitalisation or death in vaccinated, at-risk adults.
 
Much of the finding was based on the large-scale PANORAMIC study carried out in the UK using data from more than 25,000 participants. It found that while the treatment may shorten recovery times, it did not cut the most serious outcomes, with the Taskforce consequently recommending against the routine prescription of molnupiravir.
 
However, Dr Anita Muñoz, who is the RACGP Victoria Chair and sat on the college’s COVID Response Working Group until May this year, is concerned the Taskforce’s shift may deter GPs from prescribing the treatment altogether.
 
‘There can be the danger that GPs feel a guideline is overriding their own clinical judgement,’ Dr Muñoz told newsGP.
 
‘We have to consider the guidelines. [However], a large proportion of the people enrolled in the UK study would not be eligible for the treatments in Australia and these research findings cannot be directly applied to most people receiving treatments in Australia.

‘You should use Paxlovid [nirmatrelvir and ritonavir] if you can safely. But I would be concerned [if] GPs feel they can no longer use Lagevrio as a result of this guideline.’
 
Data included in the PANORAMIC study shows around only 15% of participants in the UK trial were either over 70 or classified as ‘extremely clinically vulnerable’.
 
‘In Australia, it is the most old and the people with the greatest risk factors that we are intending to target,’ Dr Muñoz said.
 
‘So there are significant differences.
 
‘It’s important to say it is an option when the first-line drug can’t be used safely, which we know does affect a substantial proportion of the patients we are targeting.’
 
Similar views have also been expressed by high-profile medical professionals, including Deputy Chief Medical Officer Professor Michael Kidd and Victoria’s Chief Health Officer, Professor Brett Sutton.
 
In the most recent emailed COVID-19 update for Primary Care, Professor Kidd describes vaccination as ‘the most important form of protection’ but said both oral antivirals are an ‘additional gamechanger’.
 
‘Australia’s real-world experience is that these two COVID-19 oral antiviral treatments approved for local use are both highly effective at protecting older Australians – a key at-risk population group – from hospitalisation and death,’ Professor Kidd stated.

On similar lines, Professor Sutton recently wrote in The Conversation citing Victorian data suggesting molnupiravir helps prevents severe disease in the over-70s.
 
‘Our analysis, which is yet to be published or independently verified by other scientists, found both Paxlovid and Lagevrio reduced the risk of hospitalisation and death. And the results were better for Paxlovid,’ he wrote.
 
‘While there’s evidence [molnupiravir] is effective at treating COVID, it’s no longer recommended in the United Kingdom because it’s not considered cost-effective.’
 
Professor Sutton, along with three co-authors, suggested the situation would remain different in this country, saying ‘both Paxlovid and Lagevrio have a role to play in Australia’s treatment arsenal’.
 
‘Some people who are unable to have Paxlovid will benefit from Lagevrio,’ they concluded.
 
In its recent change, the Taskforce acknowledged the data from Victoria as well other observational studies including from Hong Kong and Israel that have supported the use of both oral antivirals, but queried their reliability. 
 
‘The nature of these studies means that their results are open to significant bias – particularly selection bias – and substantial confounding – both the healthy user effect and confounding by indication – and cannot provide reliable evidence to determine the effectiveness, or otherwise, of molnupiravir,’ the Taskforce stated.
 
Dr Muñoz, however, believes the studies should be taken into account.
 
‘The Taskforce only considered randomised controlled trials, whereas I think it is important when you are taking responsibility for treating patients to also bear in mind other forms of evidence,’ she said.
 
‘It is observational [and] we understand that there are different tiers of evidence, but it is data nevertheless, and we need to make our decisions alongside our patients.  
 
‘To shut that option [molnupiravir] off from our patients would be very problematic [and] there’s a danger that GPs might because of what the Taskforce has said.
 
‘I also think that Australian GPs have now been treating patients with antivirals for some time and will know for themselves and their experiences what benefits they have observed in their patients.’
 
According to Dr Muñoz, the observational studies could feed into the shared decision-making process between GPs and patients.
 
‘It is important to tell patients what the whole panorama of data tells us, what the safety profile of a drug is, and then help the patient to make an informed decision for themselves,’ she said.
 
The rate of oral antiviral prescription has accelerated significantly since the two treatments were added to the PBS earlier this year.
 
The Department of Health and Aged Care (DoH) reported a 20.6% increase in prescriptions last week, with 37,513 dispensed compared to 30,980 over the previous seven days. As of the end of last week, a total 464,159 oral antiviral prescriptions had been issued overall, including 357,393 for molnupiravir and 106,766 for nirmatrelvir and ritonavir – which has a number of interactions with other drugs.
 
Those numbers come at the same time as COVID-19 hospitalisations continue to rise across Australian states and territories.
 
Referencing that trend, Professor Kidd emphasised the importance for older patients and the immunocompromised to talk to GPs about eligibility for the antiviral treatments and to begin an appropriate course as soon as possible after a positive COVID-19 test.
 
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Dr Diana Lorraine Hart, OAM   13/12/2022 6:20:12 AM

I have used Molnupiravir extensively in my nursing home and older adult patients and I have not had to admit any of them to hospital. Consequently I have considered it very valuable. As well as this it has been well tolerated with no recordable side effects whereas several of those eligible for Paxlovid have not been able to tolerate it due to severe nausea and vomiting which ceased on stopping the drug so unlikely due to COVID itself.


Dr Ian Mark Light   13/12/2022 8:56:42 AM

It is really impressive that the researchers were able to analyse that very early treatment with Molnupiravir that is within 24 hours showed great benefit in protecting against deterioration to severe disease and death in a group older than 70 and with co-morbidities.
They challenged the conclusions of other trials overseas and pointed out differences that is later treatment with Molnupiravir two days and more to lower hospital admission and four days and more markedly reduces protection against severe disease and death .
Also the mean age group differences in the trials 50-70 versus 70 plus .
Further confirmation will mean more hope and also accelerated care .


Dr Shiromali Anuja Sandagiri Ekanayake   13/12/2022 3:30:03 PM

I my self had to use Paxlovid due to my High Risk Health Issues , and it certainly helped my speedy recovery and honestly I felt within couple of hours of administering the Paxlovid how certain worrying Troublesome symptoms subsided .
And also most of Nursing Home patients had Molupiravir are really doing well
So I have first hand experience about the use and urge my colleagues not to dismiss the benefits for your community and Human kind
Thank you