Developed by AstraZeneca, the Evusheld treatment (tixagevimab and cilgavimab) with monoclonal antibodies against Covid-19 is no longer indicated, informs the DGS in January 2023.
The treatment Evusheld against Covid-19 is no longer recommended in people who have been eligible so far, because of a risk-benefit balance”which is probably no longer favorable“ indicates the General Directorate of Health (DGS) on January 31, 2023. Until now, it concerned immunocompromised patients from the age of 12 (at least 40 kilos), insufficiently responsive or non-responders after a complete vaccination schedule or not eligible for vaccination and at high risk of developing a severe form of the disease. The Paxlovid® remains the first-line curative treatment in people with mild to moderate Covid-19, regardless of SARS-CoV-2 variant or sub-variant, particularly indicated regardless of vaccination status in patients aged 65 and over, or carriers of immunosuppression, or presenting with another serious high-risk comorbidity. What were the directions of the Evusheld treatment? What are his Side effects ?
Definition: what is the Evusheld treatment?
Evusheld treatment is no longer recommended against Covid-19
Evusheld is a drug that reduced the risk of contracting Covid-19 with the active substances tixagevimab and cilgavimab, monoclonal antibodies. This drug required a hospital prescription and the administration was done intramuscularly under medical supervision. “The treatment [devait] be administered in conditions to manage an allergic reaction” recommended the HAS. The drug could be given as a treatment or before exposure.
Why is the Evusheld treatment no longer indicated against Covid?
The Evusheld treatment against Covid-19 is no longer recommended for those previously eligible, due to a risk-benefit balance that is probably no longer favorable for the following reasons indicates the DGS:
► The resistance of the BQ1.1 variant to neutralization by Evusheld. However, this variant represents 70% of circulating variants.
► The reduction in the incidence of the epidemic of Covid in France.
► The risk ofcardiovascular side effects associated with Evusheld treatment.
Which laboratory developed Evusheld?
The laboratory Astra Zeneca developed Evusheld.
What is the composition of Evusheld?
Evusheld contains the active substances tixagevimab and the cilgavimab. Tixagevimab and cilgavimab are “monoclonal antibodies” which act specifically against the SARS-CoV-2 virus by preventing it from entering human cells. Each box contains 2 vials: 1 vial containing 150 mg of tixagevimab in 1.5 mL of solution and 1 vial containing 150 mg of cilgavimab in 1.5 mL solution The other ingredients are: histidine, histidine hydrochloride, sucrose, polysorbate 80 and water.
What were Evusheld’s indications?
The combination of tixagevimab and cilgavimab was intended to prevent the risk of contracting Covid-19. This medicinal product was indicated for pre-exposure prophylaxis of Covid-19 in people 12 years and older weighing at least 40 kilos :
- Having an immune deficiency related to a pathology or treatments (including patients with solid cancer or dialysis patients) and weak or non-responders after a complete vaccination schedule in accordance with current recommendations.
- Or not eligible for vaccination and who are at (very) high risk of severe form of Covid-19.
The following are considered to be at very high risk of a severe form of Covid-19: Solid organ transplant recipients, allogeneic hematopoietic stem cell transplant recipients, lymphoid hemopathies: leukemias chronic lymphoids treated or not, lymphomas non-Hodgkin’s disease and myeloma under treatment, including patients receiving CAR-T cell gene therapy or bi-phenotypic antibody therapy, patients receiving anti-CD20 antibody therapy or BTK inhibitors or azathioprine, cyclophosphamide and mycophenolate mofetil, subjects with primary immunodeficiency. This indication is likely to change depending on the state of scientific knowledge and the epidemiological context. The combination of tixagevimab and cilgavimab is not intended to be used as a substitute for vaccination against SARS-CoV2.
Dosage: in what form?
The combination of tixagevimab and cilgavimab was given by a healthcare professional as two intramuscular injections, usually one in each buttock.
What are the side effects of Evusheld?
The observed side effects are as follows:
- Immune system disorder (hypersensitivity including rash and hives)
- General disorders and administration site conditions (injection-related reaction)
- Injuries, poisonings and complications related to procedures (injection site reaction including injection site pain, injection site erythema, injection site pruritus, injection site reaction and injection site induration)
- headaches
- fatigue
- cough
- diarrhea
- oropharyngeal pain
- Cardiovascular: Next to a signal of disproportion of cardiovascular events against Evusheld in the PROVENT and TACKLE studies, and pending additional pharmacovigilance data, caution is required before considering the administration of this dual therapy in patients at high risk of cardiovascular events, indicates the ANSM.
Patients should be made aware of early symptoms of cardiovascular events (including chest pain, shortness of breath, malaise,..) and to consult a doctor immediately if these symptoms appear.
For whom is Evusheld contraindicated?
Evusheld was contraindicated in case of:
- Hypersensitivity to the active substances or to one of the excipients of the treatment
- In patients who present with a thrombocytopenia or any bleeding disorder
- During pregnancy unless the potential benefit justifies the potential risk to mother and fetus
What is its price and is it reimbursed?
We do not have no information on its price or on its reimbursement. It is no longer indicated for the prevention of Covid-19.
Sources:
– Update of recommendations for prophylactic management against Covid-19, January 31, 2023
– Use of Evusheld® in pre-exposure prophylaxis of Covid-19, April 19, 2022, HCSP
– Covid-19: HAS extends the early access authorization granted to Evusheld, March 18, 2022, HAS
– Tixagevimab 150 mg / cilgavimab 150mg, solution for injection (EVUSHELD), updated on February 24, 2022, ANSM.
– Evusheld, a new dual therapy of monoclonal antibodies against Covid-19, authorized for early access. December 14, 2021. ANSM
– EVUSHELD (tixagevimab/cilgavimab), early access decision. December 10, 2021, HAS
– Summary of Product Characteristics – EVUSHELD. ANSM