Sotrovamab and Ronapreve for COVID positive patients
Sotrovamab and Ronapreve are both provisionally approved by the TGA. They are available for the treatment of COVID-19 in adults in limited supply through the COVID positive pathways program.
Sotrovimab and Ronapreve aim to reduce disease severity in the early stages of COVID-19. They should be used for the treatment of COVID-19 within 7 days of symptom onset in adults who do not require oxygen and who have one or more risk factors for disease progression.
Sotrovimab inclusion criteria
Sotrovimab is appropriate for use in adults with the following:
COVID-19 positive with symptom onset equal to or less than 5 days
Partially or not vaccinated for COVID-19 (people who have had two vaccinations and are due for a booster may be considered partially vaccinated)
no oxygen therapy or ventilation required
and include the presence of at least one of the following:
immunosuppressed (irrespective of vaccination status)
age ≥ 50 years
type 1 or 2 diabetes mellitus (requiring medication)
obesity (BMI > 30 kg/m2)
chronic kidney disease (i.e. eGFR < 60 by MDRD)
congestive heart failure (NYHA class II or greater)
cardiovascular disease including hypertension treated with medication
chronic lung disease (including asthma treated with regular medication)
moderate-to-severe asthma (requiring an inhaled steroid to control symptoms or have been prescribed a course of oral steroids in the previous 12 months)
chronic liver disease
paediatric patients 12 years or over with significant co-morbidities including sickle-cell disease, paediatric complex chronic conditions (PCCC), congenital and genetic, cardiovascular, gastrointestinal, malignancies, metabolic, neuromuscular, renal and respiratory conditions.
Notes:
Eligibility criteria for sotrovimab has been altered to align with ronapreve eligibility for mild COVID-19 cases.
A COVID-19 positive case can be confirmed via either a PCR test or Rapid Antigen Test.
The National COVID-19 Clinical Evidence Taskforce has provided the following recommendations:
Pregnant and breastfeeding patients, and children and adolescents, were not included in the trial; however, trials for these groups are currently underway. It is recommended pregnant women in the second or third trimester who meet the inclusion criteria above be administered sotrovimab.
Patients under 40kg should not be administered this medication. Consider using sotrovimab in exceptional circumstances for children and adolescents aged 12 years and over weighing at least 40 kilograms with the inclusion criteria above.
There is no evidence on the effectiveness of sotrovimab in immunosuppressed patients. However, given the likely higher risk of deterioration in these patients, and the absence of reasons to believe otherwise, it is likely that sotrovimab will be beneficial for immunosuppressed patients. Consider using sotrovimab in patients who are immunosuppressed regardless of vaccination status.
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.
Ronapreve inclusion criteria
There are three indications for this medication.
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Mild COVID-19
Eligibility criteria as above for sotrovimab, with symptom onset up to 7 days.
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Moderate to critical COVID-19
COVID-19 positive
seronegative for antibodies to SARS-CoV2
and must meet one of the following:
Moderate disease – stable patient presenting with respiratory and/or systemic symptoms or signs. Able to maintain Sp02>92% at rest (or above 90% for patients with chronic lung disease) with up to 4L/min oxygen via nasal prongs.
Severe disease – either a respiratory rate of ≥30 breaths /min OR SpO2 ≤92% at rest or arterial partial pressure of oxygen (Pa02)/inspired oxygen fraction (Fi02) ≤ 300.
Critical disease – either occurrence of severe respiratory failure (PaO2/FiO2 < 200), respiratory distress or acute respiratory distress syndrome (ARDS). This includes patients deteriorating despite advanced forms of respiratory support (NIV, HFNO) OR patients requiring mechanical ventilation OR other signs of significant deterioration (including hypotension or shock, impairment of consciousness or other organ failure)
Note: ronapreve should be considered in exceptional circumstances in seronegative children and adolescents aged 12 years and over and weighing at least 40 kg with moderate to critical COVID-19 who are at a high risk of disease progression.
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Post exposure prophylaxis
Adults and adolescents aged over 12 years old and weighing at least 40kg who have been exposed to an individual with SARS-CoV2 in either a household or care setting of significant exposure.
Partially or not vaccinated (people who have had two vaccinations and are due for a booster may be considered partially vaccinated)
asymptomatic or a negative PCR result (note: symptomatic patients awaiting PCR results are not eligible)
≤ 4 days from exposure (day of first exposure is day 0)
and include the presence of at least one of the following:
type 1 or 2 Diabetes mellitus (requiring medication)
obesity (BMI > 30 kg/m2)
chronic kidney disease (i.e. eGFR < 60 by MDRD)
cardiovascular disease (including hypertension treated with medication)
chronic lung disease (including asthma treated with regular medication)
chronic liver disease
for paediatric patients ≥12 years: other significant comorbidities including sickle cell disease or Paediatric Complex Chronic Conditions, congenital and genetic, cardiovascular, gastrointestinal, malignancies, metabolic, neuromuscular, renal and respiratory conditions.
