Taskforce makes conditional recommendation for use of sotrovimab
The National COVID-19 Clinical Evidence 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.
A first of its kind, the National COVID-19 Clinical Evidence Taskforce was formed to provide a clear and consistent voice of cross-disciplinary consensus on the clinical care of people with COVID-19. The Taskforce comprises 32 peak health professional bodies and delivers ‘living’ guidelines developed by more than 250 of Australia’s leading clinical experts.