Drug updated on 4/12/2024
| Dosage Form | Injection (intravenous: 500 mg/8 mL (62.5 mg/mL)) |
| Drug Class | Monoclonal antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Summary
- The anti-SARS-CoV-2 spike protein monoclonal antibody (Xevudy/ Sotrovimab) is indicated for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients who are at high risk for progression to severe disease.
- Two systematic reviews/meta-analyses were reviewed, providing insights into the effectiveness and safety of sotrovimab in treating COVID-19.
- A study focusing on solid organ transplant recipients (SOTR), a high-risk group, found that those with mild to moderate COVID-19 symptoms showed lower likelihoods of hospitalization, ICU admission, and mortality within 30 days after receiving sotrovimab compared to controls.
- Another meta-analysis involving 27,429 patients demonstrated significant reductions in mortality rate, hospitalisation rate, need for mechanical ventilation and ICU admission among those treated with sotrovimab as opposed to non-recipients; however no significant difference was observed regarding disease progression or emergency department visits between both groups.
- Despite its efficacy against both Delta and Omicron variants of COVID-19 according to one review's findings, there was no notable difference between adverse event incidence rates among individuals who received sotrovimab versus those who did not receive it.
- Overall these documents suggest that Xevudy/Sotrovimab could be an effective treatment option reducing severity outcomes such as death or hospitalization especially amongst high risk populations like Solid Organ Transplant Recipients without increasing adverse events significantly.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Sotrovimab (anti-SARS-CoV-2 spike protein monoclonal antibody) Prescribing Information. | 2023 | GlaxoSmithKline Inc., Mississauga, Ontario |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Sotrovimab therapy in solid organ transplant recipients with mild to moderate COVID-19: a systematic review and meta-analysis. | 2022 | Immunopharmacology and Immunotoxicology |
| Efficacy and safety of sotrovimab in patients with COVID-19: a rapid review and meta-analysis. | 2022 | Reviews in Medical Virology |
| Lack of efficacy for sotrovimab use in patients with COVID-19: a meta-analysis. | 2022 | Journal of Infection |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| A living WHO guideline on drugs for COVID-19. | 2020 | WHO |