The Xevudy (sotrovimab) treatment against Covid-19 is ultimately ineffective against the BA.2 variant indicates the Haute Autorité de Santé, which restricts its use in France. What are its indications? What side effects?
[Mis à jour le 2 mai 2022 à 12h08] Due to the lack of efficacy of the Xevudy treatment against the BA.2 variant of covid-19 the High Authority of Health (HAS) restricts this product’s early access clearance”only for patients affected by a strain other than the BA.2 sublineage of the Omicron variant“. Since the BA.2 variant is the majority in France, this amounts to severely limiting its use. The HAS had granted the authorization of the drug Xevudy (sotrovimab) in the indication of “treatment of adults and adolescents with coronavirus disease 2019 (Covid-19) who do not require supplemental oxygen and who are at risk of progressing to severe Covid-19” in a review published on January 7, 2022. What are the exact indications for this treatment? Is it effective against the Omicron variant of Covid-19 ? What are its side effects?
Definition: What is the Xevudy treatment?
Xevudy is a curative treatment for Covid-19 with the active substance sotrovimaba monoclonal antibody. It is a drug reserved for a hospital use. This treatment is administered by intravenous infusion in the hospital. Each vial contains 500mg of sotrovimab in 8mL of solution. The other ingredients are: histidine, histidine monohydrochloride, sucrose, polysorbate 80, methionine and water for injections.
What are the indications in France?
The French National Authority for Health (HAS) has granted post-MA early access authorization (marketing authorization) to the drug Xevudy (sotrovimab) from the laboratory GlaxoSmithKline (GSK) in the indication of “treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (Covid-19) only subject to the sensitivity of the SARS-CoV-2 strain to Xevudy®, which excludes patients affected by the BA.2 sublineage of the Omicron variant, which do not require oxygen supplementation and which are at risk of progressing to severe Covid-19“namely the following populations as defined by the ANRS-Emerging Infectious Diseases:
- Patients 80 years and older;
- Patients with an immunity deficiency linked to a pathology or treatment:
- Current chemotherapy,
- Solid Organ Transplantation,
- Allogeneic Hematopoietic Stem Cell Transplantation,
- Systemic or vascular lupus with immunosuppressive therapy,
- Corticosteroid treatment > 10 mg/day of prednisone equivalent for more than 2 weeks,
- Immunosuppressive therapy including rituximab;
- Patients at risk of complications:
- Obese (BMI > 30 kg/m²),
- COPD and chronic respiratory failure,
- Complicated hypertension,
- Heart failure,
- Diabetes (type 1 and type 2),
- chronic renal failure,
- Other chronic pathologies
Xevudy had obtained marketing authorization fromEuropean Medicines Agency (EMA) on December 17, 2021. HAS recalls that Xevudy does not exempt patients from compliance with barrier and physical distancing measures and that this medicine is not intended to be used as a substitute for vaccination against Covid-19.
How effective against Covid-19 and the Omicron variant?
The active substance Sotrovimab is a monoclonal antibody entirely of human origin which has a double action: a neutralizing action in preventing the virus from infecting new cells and a powerful effector action in eliminating the cells already infested. According to studies relayed by the HAS, Xevudy would reduce the risk of progression to a severe form of Covid-19 (hospitalization for more than 24 hours or death) byabout 80% (COMET-ICE study) after administration of the treatment. Nevertheless, regarding the variant BA.2 of the Omicron strain, “the neutralizing activity of this monoclonal antibody seems greatly diminished” specifies the HAS on April 29.
What are the side effects ?
“The allergic reactions in Xevudy are common, and may affect up to 1 in 10 people” indicates the European Medicines Agency (EMA). The side effects are: rash or redness, itching, difficulty in breathing, feeling dizzy. Finally, the infusion for the administration of Xevudy present the risk of adverse effects : flushing, chills, fever, difficulty breathing, rapid heartbeat, low blood pressure.
What is the dosage?
“The recommended dose for adults and adolescents (aged 12 years and over and weighing at least 40 kg) is 500mg (one vial) administered intravenously in a healthcare facility where patients can be monitored during administration and for at least 1 hour after administration“, indicates the HAS. It is recommended toadminister within 5 days of onset of Covid-19 symptoms“says the HAS.
Which laboratory markets Xevudy?
Xevudy® (sotrovimab) is marketed by the laboratory GlaxoSmithKline (GSK).
Sources:
Early access decision, Xevudy (sotrovimab) – Covid-19 curative treatment, 7 January 2022, HAS
Decision n° 2022.0001/DC/SEM of January 6, 2022 of the College of the High Authority for Health authorizing early access for the proprietary medicinal product XEVUDY
“Curative treatment against Covid-19: a new monoclonal antibody in the therapeutic arsenal”, ANSM, published on January 11, 2022