Taskforce makes new conditional recommendation for sotrovimab
The Taskforce today published three recommendations on the use of sotrovimab for the treatment of COVID-19 in adults who do not require oxygen and who have risk factors for disease progression. These are the first recommendations from the Taskforce to use a drug to treat patients with mild illness.
The Taskforce updated the sotrovimab recommendation after receiving access to additional data from the COMET-ICE Trial contained in the Clinical Study Report and the Australian Public Assessment Report (AusPAR).
The recommendations are:
Consider using sotrovimab for the treatment of COVID-19 within five days of symptom onset in adults who do not require oxygen and who have one or more risk factors for disease progression.
Based on the inclusion criteria of the trial, risk factors for disease progression include the following:
- Diabetes (requiring medication)
- Obesity (BMI > 30 kg/m2)
- Chronic kidney disease (i.e. eGFR < 60 by MDRD)
- Congestive heart failure (NYHA class II or greater)
- Chronic obstructive pulmonary disease (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)
- Age ≥ 55 years
Within the patient population for which sotrovimab is conditionally recommended for use (as listed above), decisions about the appropriateness of treatment with sotrovimab should be based on the patient’s individual risk of severe disease, on the basis of age or multiple risk factors, and COVID-19 vaccination status.Consider using sotrovimab in unvaccinated or partially vaccinated patients and patients who are immunosuppressed regardless of vaccination status.
Do not routinely use sotrovimab in fully vaccinated patients unless immunosuppressed.
Given the absence of evidence evaluating the effectiveness of sotrovimab for key patient subgroups and SARS-CoV-2 variants of concern, rigorous data collection should be undertaken on indications and key outcomes for patients who receive treatment with sotrovimab.
Taskforce Executive Director Prof Julian Elliott said the monoclonal antibody therapy was a welcome addition to the Taskforce list of recommended treatments.
‘As the first recommendation from the Taskforce for the treatment of patients with mild COVID-19, these recommendations are an important milestone.
‘Sotrovimab has been conditionally recommended for patients with mild COVID-19 who are likely to progress to severe disease. In making these recommendations, the Taskforce was aware that clinicians need guidance for patients that were not included in the trial, particularly vaccinated and immunosuppressed patients. Given the absence of evidence in these subgroups the Taskforce has developed a consensus recommendation based on the combined experience of our multidisciplinary clinical experts.
‘We also recognise the need for further research and data collection to better understand the effects of sotrovimab in key patient subgroups and we look forward to further data and published evidence to inform our living recommendations.’
The Taskforce is currently developing specific recommendations on the use of sotrovimab for pregnant women, children and adolescents. These will be published in a future version of the guidelines.
New Respiratory and Eye Protection Decision Aid
As healthcare workers across Australia continue to face increased risk of exposure to SARS-CoV-2, the Taskforce Infection Prevention and Control Panel have developed a visual Decision Aid to help clinicians apply the PPE guidance in practice.
New immunodulatory treatments comparison table
The Taskforce has developed a comparison table of the recommended immunodulatory treatments (tocilizumab, baricitinib and sarilumab), including clinical and non-clinical information to help guide clinicians in selecting the most appropriate treatment for their patients.
Ivermectin FAQs
To support clinicians in providing evidence-based advice regarding the use of ivermectin as a treatment for COVID-19, the Taskforce has created a one-page pdf that covers our most frequently asked questions. This is available for download from the website here. The Taskforce recommends that ivermectin should only be used for the treatment for COVID-19 in the context of randomised trials with appropriate ethical approval.
COVID-19 research pipeline
NEW RECOMMENDATIONS
Conditional recommendation
Consider using sotrovimab for the treatment of COVID-19 within five days of symptom onset in adults who do not require oxygen and who have one or more risk factors for disease progression.Consensus recommendation
Within the patient population for which sotrovimab is conditionally recommended for use (as listed above), decisions about the appropriateness of treatment with sotrovimab should be based on the patient’s individual risk of severe disease, on the basis of age or multiple risk factors, and COVID-19 vaccination status.Consider using sotrovimab in unvaccinated or partially vaccinated patients and patients who are immunosuppressed regardless of vaccination status.
Do not routinely use sotrovimab in fully vaccinated patients unless immunosuppressed.
Research recommendation
Given the absence of evidence evaluating the effectiveness of sotrovimab for key patient subgroups and SARS-CoV-2 variants of concern, rigorous data collection should be undertaken on indications and key outcomes for patients who receive treatment with sotrovimab.
UPDATED RECOMMENDATIONS
New comparison table for tocilizumab, baricitinib and sarilumab
The Taskforce is continually monitoring research to update recommendations as new evidence emerges.
11 clinical flowcharts have been developed by the Taskforce to cover:
Changes to the flowcharts this week reflect:
We are currently reviewing evidence to develop recommendations and flowcharts to guide practice in areas including:
Cochrane
The full list of Cochrane Reviews and related COVID-19 content from the Cochrane Library can be found here.
It is a core mission of the Taskforce to engage with frontline clinicians to rapidly identify and address priority clinical questions.
Each week we collect suggestions for new clinical questions or topics for consideration by the Taskforce. A document that lists all of the suggested questions, topics and new patient groups that we have received to date is available here.
Please encourage your clinical colleagues to provide their insights via the website.