COVID-19 oral antivirals and sotrovimab in Aboriginal Community Controlled Health Services

This article covers medicines available for the treatment of non-hospitalised people diagnosed with COVID-19 and within 5 days of symptom onset.

Medicines are now available for the treatment of COVID-19 outside the hospital setting for people with mild-moderate illness. Allocation of these medicines has been prioritised to ensure rapid access for Australians with the highest clinical need. This includes Aboriginal or Torres Strait Islander people, and those living in remote communities. This article covers medicines available for the treatment of non-hospitalised people diagnosed with COVID-19 and within 5 days of symptom onset.

Information relevant to use of oral antiviral medicines within residential aged care facilities – another high clinical need population - can be found here.

General tools and resources to support the safe and effective provision of medicines in remote communities can be found here.

 

General medicine information

What are these medicines?

Molnupiravir (Lagevrio)

Nirmatrelvir plus ritonavir (Paxlovid)

Sotrovimab (Xevudy)

Antiviral

Antiviral

Monoclonal antibody

Oral administration (capsule)

Oral administration (tablet)

Intravenous administration

Product information

Consumer Medicine Information

Product information

Consumer Medicine Information

Product information

Consumer Medicine Information

Factsheets about each of these medicines are available to support discussions between prescribers and health care workers and their patients:

How are these medicines accessed?

Molnupiravir 

Nirmatrelvir plus ritonavir

Sotrovimab 

Through state and territory health departments 

PBS eg, community pharmacy or section 100 RAAHS (specific PBS clinical criteria apply)

All three medicines are prescription only (S4). This means they require a valid medication order from a prescriber as per state/territory medicines laws before treatment can be commenced. Practitioners should ensure medicines are labelled in accordance with their state/territory laws and in a way that is suitable for the person who will take or administer the medicine.

The oral antivirals molnupiravir and nirmatrelvir plus ritonavir are PBS-listed for prescription by GPs and other authorised prescribers, for dispensing by community pharmacists across Australia. 

People who may not meet the PBS clinical criteria may still be able to access the oral antiviral medicines or sotrovimab through state and territory health department. In certain jurisdictions some patients with mild COVID-19 symptoms (not requiring oxygen due to COVID-19) may be eligible to receive other treatments such as remdesivir or casirivimab plus imdevimab.

Primary care prescribers should follow the standard processes in their state or territory for access and approvals.

Read more about how medical professionals can access COVID-19 treatments through the National Medical Stockpile.

Who are they for?

All three medicines have provisional approval from the Therapeutic Goods Administration (TGA) for people with mild–moderate COVID-19, as described below.

Molnupiravir

Nirmatrelvir plus ritonavir

Sotrovimab

Indication

Treatment of adults with COVID-19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk for hospitalisation or death

Treatment of coronavirus disease 2019 (COVID-19) in adults 18 years of age and older, who do not require initiation of supplemental oxygen due to COVID-19 and are at increased risk of progression to hospitalisation or death

Treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death

Dosing

800 mg (four 200 mg capsules) orally every 12 hours for 5 days, with or without food

300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) orally every 12 hours for 5 days

Single 500 mg dose given as an IV infusion over 30 minutes

Dose adjustmentsNo dose adjustment required Kidney: Moderate renal impairment (GFR ≥ 30 to <60mL/min) reduce dose of nirmatrelvir/ritonavir to 150 mg/100 mg every 12 hours for 5 days
Severe renal impairment (<30mL/min) contraindicated due to lack of available data
Liver: No dosage adjustment required in mild or moderate liver impairment. Contraindicated in severe renal or liver impairment
No dose adjustment required

PBS listing clinical criteria for molnupiravir and nirmatrelvir plus ritonavir includes Aboriginal and Torres Strait Islander people aged 50 and older and at high risk. Full prescribing information including clinical criteria and definition of high risk are available through the PBS website (https://www.pbs.gov.au/).

Dosing guidance for all three medicines is to administer:

  • as soon as possible after a diagnosis of COVID-19, and
  • within 5 days of symptom onset (safety and efficacy after 5 days has not been established)

The decision to prescribe should be informed by the TGA indication, any available PBS clinical criteria and recommendations provided through the National COVID-19 Clinical Evidence Taskforce.

 

Clinical guidance

Pivotal trials for all three medicines have only evaluated outcomes in unvaccinated people at increased risk of severe disease. To ensure these medicines are used in those at greatest risk, the National COVID-19 Clinical Evidence Taskforce currently recommends considering treatment for adults who are:

  • unvaccinated and have one or more risk factors for disease progression, or
  • immunosuppressed or not immunocompetent, regardless of vaccination status, or
  • have received one or two doses of a COVID-19 vaccine and are at high risk of severe disease on the basis of age and multiple risk factors.

Additionally, the Taskforce recommend clinicians should only consider molnupiravir where other treatments such as nirmatrelvir plus ritonavir or sotrovimab are not suitable or available. 

Clinicians should note that where infection with Omicron BA.2 is confirmed or considered likely, use of sotrovimab should only be considered where other treatments are not suitable or available.

In certain jurisdictions some patients with mild COVID-19 symptoms (not requiring oxygen due to COVID-19) may be eligible to receive remdesivir or casirivimab plus imdevimab. 

Individual prescribers will be best placed to determine whether a particular medicine is suitable for a patient’s own clinical circumstances, including time since vaccination and time since onset of symptoms 

Guidance on accessing and prescribing any of these medicines according to individual states and territories can be found below. 

ACT

NSW

NT

Qld

SA

TAS

Vic

WA

 

Risk factors for disease progression

The definition of risk factors for disease progression varies across treatments, and is based on the inclusion criteria of pivotal studies for each medicine (see table below). 

PBS clinical criteria for the prescribing of the oral antivirals, including risk factors for severe disease progression, are different to those described by the National COVID-19 Clinical Evidence Taskforce. The listing includes Aboriginal and Torres Strait Islander people aged 50 and older and at high risk. Prescribers are advised to refer to the PBS website for further information.

It is important to note that for some jurisdictions being over 35 years of age is considered an additional risk factor for severe COVID-19 disease in Aboriginal and Torres Strait Islander patients.

Risk factors for disease progression (based on key clinical studies)

Molnupiravir

Nirmatrelvir plus ritonavir

Sotrovimab

Age ≥ 60 years

Diabetes mellitus

Obesity (BMI ≥ 30 kg/m2)

Serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies

Chronic obstructive pulmonary disease

Chronic kidney disease (ie, eGFR < 60 mL/min/1.73 m2 by MDRD), excluding patients on dialysis

Active cancer (excluding minor cancers not associated with immunosuppression, eg, basal cell carcinomas)

Immunocompromised state following solid organ transplant

Sickle cell disease

Age ≥ 60 years

Diabetes (requiring medication)

BMI ≥ 25 kg/m2

Cardiovascular disease

Hypertension

Chronic lung disease

Current smoker

Patients with the following conditions are also likely to benefit from treatment:

Chronic kidney disease (but where the eGFR ≥ 30mL/min)

Cancer (other than localised skin cancer)

Immunosuppressed

Prolonged iatrogenic immunosuppression

Sickle cell disease

Medical-related technological dependence (eg, CPAP not related to COVID-19)

HIV positive (CD4 cell count <200m3; viral load < 400 copies/mL)

Neurodevelopmental disorders (eg, cerebral palsy, Down’s syndrome)

Age ≥ 55 years

Diabetes (requiring medication)

Obesity (BMI ≥ 30 kg/m2)

Congestive heart failure (NYHA class II or greater)

COPD (history of chronic bronchitis, chronic obstructive lung disease, or emphysema with dyspnoea on physical exertion)

Moderate-to-severe asthma (requiring an inhaled steroid to control symptoms or prescribed a course of oral steroids in the previous 12 months)

Chronic kidney disease (ie, eGFR < 60 mL/min/ 1.73m2 by MDRD)

BMI = body mass index, COPD = chronic obstructive pulmonary disease, CPAP = continuous positive airway pressure, eGFR = estimated glomerular filtration rate, MDRD = modification of diet in renal disease

 

Where do they fit in the treatment of COVID-19?

There is no available head-to-head clinical trial evidence allowing direct comparison of the efficacy (or safety) of the three medicines. They should not be considered for people who have received three doses of a COVID-19 vaccine unless the person is immunosuppressed or not immunocompetent. The efficacy of these medicines in people who have received one or two doses of a vaccine is not established - the therapies may be considered for use and informed by the patient’s risk factors for disease progression.

In the pivotal clinical trials, sotrovimab, and nirmatrelvir plus ritonavir demonstrated strong efficacy (reduce hospitalisation or death) compared with no active treatment. There is emerging in vitro data to suggest that sotrovimab may have lower efficacy against Omicron strains than earlier variants.

Trial evidence for molnupiravir was not as strong. However, compared with the other currently available oral option, molnupiravir has few contraindications, making it a reasonable second line choice in the management of mild-moderate COVID-19. 

View our summary table for an in-depth comparison of each COVID-19 treatment available for use in Australia https://www.nps.org.au/coronavirus/summary-table-molnupiravir-nirmatrelvir-ritonavir-and-sotrovimab

The National COVID-19 Clinical Evidence Taskforce have published an updated pathway to support treatment decisions involving non-hospitalised patients with mild-moderate COVID. (please note the pathway includes other agents not a focus of this NPS MedicineWise article). 

What are the potential side effects?

Pivotal safety data for molnupiravir, nirmatrelvir plus ritonavir and sotrovimab are each limited to results from a single trial.

Informed consent should be obtained from the patient (or responsible person) prior to initiating treatment and recorded in the patient’s notes. (see section below How should consent be managed? for more information)

Molnupiravir

Nirmatrelvir plus ritonavir

Sotrovimab

Most common treatment-related adverse effects were mild–moderate, occurring at similar rates for treatment and placebo groups:

  • diarrhoea 1.7% (treatment); 2.1% (placebo)
  • nausea (1.4%; 0.7%)
  • dizziness (1.0%; 0.7%).

Most common treatment-related adverse effects were mild–moderate and included:

  • dysgeusia (altered taste) 5.6% (treatment); 0.3% (placebo)
  • diarrhoea (3.1%; 1.6%)
  • headache (1.4%; 1.3%)
  • vomiting (1.1%; 0.8%).

Most common treatment-related adverse effects were mild–moderate and included:

  • nausea < 1% (treatment); 2% (placebo)
  • diarrhoea (2%; < 1%)
  • headaches (< 1%; 2%).

Prescribers are reminded that these side effects can lead to significant morbidity such as dehydration, delirium and falls in frail, elderly people.

Health practitioners are encouraged to keep in contact with people prescribed the antiviral medicines, to help monitor adherence, changes to symptoms and to report any side effects.

How to report a potential adverse drug reaction

  • Report online: Complete the online form to report a possible medicine or vaccine adverse reaction.
  • Report by email: [email protected] to report a possible medicine or vaccine adverse reaction. The email should include:
    • contact details
    • a description of the adverse reaction (what happened, when it happened and how long it lasted)
    • a description of the medicine or vaccine thought to have caused the adverse reaction (including any other medicines or medical devices being taken or used by the person experiencing the adverse event).

In addition, medical practices using the Best Practice or Medical Director software can download and install templates to their software to create Adverse Drug Reaction reports. Completed reports can be emailed, faxed or posted to the TGA.

What are the potential contraindications and drug interactions to know about?

Molnupiravir

Nirmatrelvir plus ritonavir

Sotrovimab

Contraindications

Hypersensitivity to the active substance or any of the excipients

Hypersensitivity to the active substance or any of the excipients

Severe renal impairment (<30mL/min) contraindicated due to lack of available data

Contraindicated in severe renal or liver impairment Contraindications corresponding to drug-drug interactions related to ritonavir

Hypersensitivity to the active substance or any of the excipients

Drug-drug interactions

No drug interactions identified based on limited data available

Drug interactions considered unlikely based on pharmacology

No drug interaction studies yet

Multiple and significant interactions primarily related to ritonavir

Before prescribing, use the Liverpool interaction checker to determine potential drug–drug interactions with medicines the patient is taking

No formal interaction studies conducted yet

Not renally excreted or metabolised by CYP P450 enzymes so interactions unlikely

Management of drug–drug interactions with nirmatrelvir and ritonavir can be complex. In some cases, the recommendation is to avoid co-administration. Other strategies may include:

  • stopping the medicine(s) that interact with nirmatrelvir and ritonavir and restarting 3 days after the last dose of nirmatrelvir and ritonavir (temporary cessation for 8 days in total)
  • adjusting the dose of the medicine(s) that interact with nirmatrelvir and ritonavir and readjusting to the original dose 3 days after the last dose of nirmatrelvir and ritonavir.

If changes are made to a persons regular medicine regimen inform their usual pharmacy to ensure consistency with instructions, and appropriate adjustments to dose administration aids (DAAs) if used.

Read more in the RADAR article Nirmatrelvir and ritonavir (Paxlovid) for mild-to-moderate COVID-19.

Which medicines are not suitable for people of childbearing age?

Molnupiravir

Nirmatrelvir plus ritonavir

Sotrovimab

Pregnancy

Not recommended

  • advise people of childbearing potential to use effective contraception during treatment and for 4 days after last dose.

Not recommended in pregnancy

  • advise people of childbearing potential to use effective contraception (excluding combined hormonal contraceptives) during treatment and for 7 days after the last dose.

Pregnancy category B2 (insufficient human data)

  • only use if the expected benefit justifies the potential risk to the fetus and the patient is in their 2nd or 3rd trimester

Breastfeeding

Not recommended during treatment and for 4 days after last dose based on potential adverse effects in infants.

Discontinue during treatment and for 7 days after last dose.

Insufficient data

  • consider the benefit of breastfeeding for the child and benefit of therapy for the mother

Conception

Unknown how molnupiravir may affect sperm

  • people who are sexually active with a partner of childbearing potential should use appropriate contraception during treatment and for 3 months after the last dose.
 

Consider arranging consent in advance of people becoming infected or of outbreaks occurring. This allows discussions and agreement to take place between staff and the patient, other family members or other responsible persons (as required) about how to manage treatment should infection occur.

Ensure culturally-safe practices are followed to obtain informed consent prior to initiating treatment. Support shared decision making by discussing benefits and potential harms from use of these medicines.

It is important for prescribers and pharmacists to have an understanding of which family members might need to be included in shared clinical decision making or to ask if other family members need to be involved. This may also include extended family, people to help with translation, Indigenous support officers or Aboriginal Health Workers.

What else might help inform medicine choice?

Oral antiviral treatments can be self-managed at home or at the usual place of residence following dispensing and education on their use. If one of these medicines is an appropriate treatment option, consider availability of staff to monitor patient over the 5-day course to support medicine adherence and monitor adverse effects. Counselling for contraception may also be needed.

Prescribing considerations related to sotrovimab:

  • individual service to consider if they can monitor clients during a 30-minute infusion and for a further 60 minutes post infusion
  • can service provide isolation as the patient is infectious.

Other considerations that may support use of sotrovimab over other options can include overcrowded living conditions, having no secure place to store medicines away from children and low patient literacy levels making reading labels and following information difficult.

Sotrovimab administration may be preferred where appropriate storage of medicines is not possible (eg, they should be stored away from children) or where low patient literacy or treatment concordance impacts the likelihood of adherence to the full 5-day course of oral treatment.

Factsheets about each of these medicines are available to support discussions between prescribers or health care workers and their patients:

What can be done to support adherence and safe use of COVID-19 medicines?

The following strategies may be useful to consider when prescribing for Aboriginal and Torres Strait Islander or remote area communities:

  • Choose treatment option that fits best with other existing health care needs. For some people a sotrovimab infusion may be simpler as only a single dose is required, placing no additional burden on existing medication regimens. For others inclusion of oral medicine into existing DAA packs or other medication routines may be preferred.
  • Consider the capacity of the patient to physically access their medicine. Molnupiravir comes in a bottle while nirmatrelvir plus ritonavir comes in a blister card with morning and evening doses marks.
  • Be clear to use local terminology when explaining times to take medicine doses. The terms dinner, lunch and supper can be different for different communities.
  • Where required and available, engage Aboriginal health workers to support shared decision making and counselling.
  • Match education tools and resources to the literacy needs of the person. 
  • Consider how a medicine might be stored – molnupiravir requires storage below 30°C compared with nirmatrelvir plus ritonavir which requires storage below 25°C. This may make it more suitable for some locations.
 

How urgently should the first dose of an oral antiviral be administered?

Treatment with an oral antiviral must begin as soon as possible after a diagnosis of COVID-19, and within 5 days of symptom onset. Timely access to these medicines is important to ensure best possible outcomes. ACCHSs are encouraged to work with their local hospital and health services to establish clearly documented pathways for the dispensing of oral antivirals or alternative systems when safe collection by the patient is not possible.

To minimise disruption to initiation, each ACCHS is encouraged to develop medicine management policies and procedures, similar to those for administering other medicines in an emergency or acute situation that specify circumstances where a registered nurse can delegate medicine administration to other appropriately trained and competent staff (where this is permitted by relevant state or territory legislation and regulation). The relevant LHD and pharmacy department should establish a system where medications will be supplied to remote locations, facilities or health services for individuals who are unable to arrange the safe collection of oral agent courses.

Could more than one person be supplied doses from the same pack of molnupiravir or nimatrelvir plus ritonavir?

This is not a recommended way to manage multiple patients.

Each bottle of molnupiravir contains 40 capsules, and each pack of nirmatrelvir plus ritonavir contains 30 tablets in blister packs, sufficient for one person to complete a 5-day course. This is the required duration of treatment to optimise benefit for anyone prescribed this medicine. Splitting a single product among multiple people increases the risk of missing doses or not completing a full course.

Can a ACCHS order more stock of preplaced molnupiravir or nimatrelvir plus ritonavir?

Additional supplies of stock for ACCHS of both molnupiravir and nirmatrelvir plus ritonavir are available through the PBS. See the PBS for more details.

How should unused oral antiviral medicines be safely disposed of?

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Anyone handling molnupiravir should consider the risks of exposure (refer to the molnupiravir PI for more information; Section 4.6 Fertility, Pregnancy and Lactation).

 

Does an ACCHS need to inform a community pharmacy, which regularly supplies dose-administration aids, if a patient is prescribed an oral antiviral?

During February 2022 supplies of the oral antiviral medicines molnupiravir and nirmatrelvir plus ritonavir were pre-placed at every ACCHS across Australia. Once prescribed, the service’s pre-placed medicines supply must be used in a manner consistent with medicine regulation in their jurisdiction. The medication package contains one full course for one client (nirmatrelvir plus ritonavir renal impairment clients excluded).

If the service determines that an oral antiviral should be included within a pre-prepared dose administration aids (DAA) pack, they may need to liaise with their community pharmacy to arrange for the medicine’s inclusion.

When deciding if an antiviral should be packed, it may be useful to consider the risk of possible non-adherence if not included in a DAA. The time taken for packing the DAA should also be considered, given the need to start treatment quickly.

Please note: it has been reported that both molnupiravir and nirmatrelvir plus ritonavir appear stable when kept under manufacturer defined storage conditions. It is unknown if potency or physical integrity of either product is impacted if removed from original packaging before and then repacked in a DAA.

What are the storage instructions?

Ensure there is an appropriate secure location to store medications. Different treatments should be clearly labelled and differentiated on the shelf. Refer to the storage requirements in the Product Information for each medicine.

  • Molnupiravir must be stored below 30°C
  • Nirmatrelvir plus ritonavir stored below 25°C.
  • If storing sotrovimab solution, it must be kept in the fridge between 2°C and 8°C.

What other administration requirements should an ACCHS be aware of?

Administration and supply of sotrovimab treatment should occur in a hospital/healthcare facility that has infection control measures clearly outlined and in place, to minimise contact between an infected person and other people. This should include a booking process that allows consent to be obtained by phone prior to attendance at the infusion facility and the provision of personal protective equipment for the person and any support people. The facility will also require clinical emergency response system protocols to monitor adverse events including initial management of anaphylaxis.

Confirm transport options to enable patient access as part of the booking process including identification of accessible car parking or availability for transportation through a patient transport service is necessary.

Can molnupiravir, nirmatrelvir plus ritonavir or sotrovimab be prescribed for staff at an ACCHS?

Pre-placement of molnupiravir or nirmatrelvir plus ritonavir at an ACCHS is for the treatment of people who access the service, and those living in remote communities, who meet the clinical criteria.

Molnupiravir and nirmatrelvir plus ritonavir are now available through PBS prescription, and all three medicines are also available through state and territory health departments. 

Staff diagnosed with COVID-19 who meet the clinical criteria may be able to access one of these medicines.

 
 

Information for consumers/patients

What to do if you, or a family member, test positive for COVID-19 (information for Aboriginal and Torres Strait Islander communities, including translations in 5 indigenous languages)

Molnupiravir (Lagevrio) Consumer Medicines Information

Nirmatrelvir plus ritonavir (Paxlovid) Consumer Medicines Information

Sotrovimab (Xevudy) Consumer Medicines Information

NPS MedicineWise factsheets:

 

References

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Australian National COVID-19 Clinical Evidence Taskforce. Australian guidelines for the clinical care of people with COVID-19 - Molnupiravir (Lagevrio) for adults.

Australian National COVID-19 Clinical Evidence Taskforce. Australian guidelines for the clinical care of people with COVID-19 - Nirmatrelvir plus ritonavir (Paxlovid) for adults.

Australian National COVID-19 Clinical Evidence Taskforce. Australian guidelines for the clinical care of people with COVID-19 - sotrovimab (Xevudy) for adults.

European Medicine Agency. Assessment report. Procedure under Article 5(3) of Regulation (EC) No 726/2004. Use of molnupiravir for the treatment of COVID-19. Committee for Medicinal Products for Human Use (CHMP).

European Medicine Agency. Assessment report. Procedure under Article 5(3) of Regulation (EC) No 726/2004. Paxlovid. Committee for Medicinal Products for Human Use (CHMP).

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