Two newly approved oral treatments for Covid-19 are recommended mainly for unvaccinated patients and will not be available for Australia’s general practitioners to prescribe for “many, many weeks”.
The antiviral drugs Lagevrio and Paxlovid block the ability of the Sars-CoV-2 virus to replicate in the body, and were provisionally approved by the Therapeutic Goods Administration on 20 January.
The treatments can only be given to adults with mild to moderate Covid-19, who do not yet require oxygen, and must be administered within five days of when symptoms begin.
The federal government secured 500,000 treatment courses of Paxlovid and 300,000 courses of Lagevrio for use this year.
Amid global supply constraints, distribution of the antivirals has begun via the National Medical Stockpile – a reserve of pharmaceuticals and PPE managed by the federal government for use during public health emergencies.
Australia’s deputy chief medical officer, Prof Michael Kidd, said the treatments would possibly be listed on the Pharmaceutical Benefits Scheme (PBS) “in the coming months”.
“We won’t be doing normal prescriptions [for the Covid antivirals] until this is on the PBS,” he said.
“As supply of these treatments comes into the country, the initial distribution is going to need to be prioritised to those who are at the highest clinical need,” Kidd said.
“They’ll go to residential aged care facilities, to rural and remote communities – particularly those regions with high Aboriginal and Torres Strait Islander populations – and directly to the state and territory governments for distribution to those at highest risk in the community, including people with disability.”
Lagevrio would be placed in residential aged care facilities as soon as possible, Kidd said.
Paxlovid – which has numerous drug contraindications that may make it unsuitable for elderly patients on other medications – will be distributed to state and territory health authorities.
Dr Karen Price, the president of the Royal Australian College of General Practitioners, said: “Prescription using a normal prescription pad is many, many, many weeks off at this stage.”
Associate professor Paul Griffin, the director of infectious diseases at Mater Health Services, said GPs would eventually “have a huge role to play” in prescribing the antivirals, but it was too early to know exactly how distribution would occur.
“There’s no question that – given these are oral [medications] and need to be given early – they’re very much going to be community focused,” Griffin said. “We know that GPs are the backbone of healthcare in that setting.”
Clinical guidelines for both antiviral drugs – which health experts emphasise are not a substitute for Covid vaccination – specify a focus on at-risk unvaccinated adults.
Clinical trials of both drugs found they reduced hospitalisation and deaths in people with Covid-19 when given within five days of the onset of symptoms. However, trials did not include individuals who were partially or fully vaccinated.
“These medicines were trialled before the vaccine was widely distributed,” Griffin said.
The antivirals are also recommended for people who are immunosuppressed or “have received one or two doses of vaccine and who are at high risk of severe disease on the basis of age and multiple risk factors”.
“People who have not been vaccinated remain at the highest risk,” Kidd said. “Treatments will most likely be of most benefit to people aged 60 and above, and those who have significant medical conditions such as diabetes, obesity, heart disease, chronic lung disease or cancer.”
Dr Diego Silva, a senior lecturer in bioethics at the University of Sydney, said providing the treatments to unvaccinated people aligned with the goal of treating people “at highest risk of progressing to serious disease”.
Criticisms that unvaccinated people “didn’t do anything to protect themselves, [so] why should they get priority or why should they have equal access” run counter to the purpose of universal healthcare, Silva said.
Healthcare was set up to “treat you no matter whether you’re at ‘fault’ or not,” he said.
Griffin agreed. “If people have made a decision not to be vaccinated, whilst I certainly wouldn’t endorse that decision, our role when they get Covid … is to do everything we can to stop them getting unwell,” he said. “In medicine, our role is not to be judgmental.”
Prof Trent Twomey, the president of the Pharmacy Guild of Australia, on Tuesday welcomed the first lot of antiviral deliveries from the National Medical Stockpile, but said more needed to be done to secure additional doses amid global supply chain shortages.
“We look forward to working with government on getting more detail around when the Covid oral treatments will be listed on the PBS and can start rolling out to communities around the country,” he said.
The Department of Health was contacted for comment.
