Ronapreve drug – monoclonal antibody in the treatment of COVID-19

Article by Pharmacist Duong Thanh Hai - Clinical Pharmacist - Faculty of Pharmacy - Vinmec Times City International Hospital

Ronapreve drug is a monoclonal antibody drug that is researched and urgently licensed to treat Covid-19 in many countries around the world. The drug has undergone clinical trials and is being indicated for the treatment of patients with mild to moderate symptoms and those at high risk of severe disease progression.

Ronapreve drug is a "cocktail" of Casirivimab and Imdevimab that has been urgently licensed to treat the Covid-19 pandemic in many countries around the world including in the European Union, the US, Canada, India.. The drug has also been first fully approved in Japan for the treatment of patients with mild-to-moderate symptoms of Covid-19 and those at high risk for severe progression.
Ronapreve belongs to a class of drugs known as monoclonal antibodies -mAbs- which are lab-made molecules that can mimic natural antibodies made by the immune system to fight disease.

Casirivimab and Imdevimab are immunoglobulin G-1 (IgG1) monoclonal antibodies, specific to the spike protein S1 and S2 of the SARS-CoV-2 virus, which prevent the virus from attaching to the ACE2 receptor on the cell surface. and prevent the entry of viruses into cells in organs in the human body. The drug is a combination of one type of COVID-19 immune cell-derived mAbs taken from recovered patients and the other created in mice that have been genetically engineered to have a human immune system. . The advantage of combining the two is that they target two different parts of the spike protein, reducing the chance of the virus becoming resistant.
Drugs that strengthen the immune system to eliminate the virus, similar to the plasma therapy of people who have recovered from the disease. However, the advantage of monoclonal antibodies is that they are homogenous and only bind specifically to the coronavirus. Therefore, it causes less side effects like plasma and does not affect other cells of the body.

The drug to treat Covid-19 Ronapreve has undergone several clinical trials around the world. By July 2021, about 16,000 Covid-19 patients had been given the drug in trials. Studies have reported that the drug reduces hospitalization or death by 70%, duration of symptoms, and shortens the time to viral clearance. In addition, a phase 3 study of 1,505 people who had been exposed to someone with COVID-19 in the previous 96 hours (F1) with half given Ronapreve, half a placebo. As a result, those in the Ronapreve group were 81% less likely to contract Covid-19 than those in the placebo group.

Ronapreve is used for adult or pediatric COVID-19 patients 12 years of age or older, weighing at least 40 kg with mild to moderate symptoms, and who are at high risk of disease progression heavy.
The dose used is 1,200 mg as a combination dose, where 600 mg of casirivimab and 600 mg of imdevimab are administered by intravenous infusion or subcutaneous injection as a single dose. The drug should be used as soon as possible after a positive PCR test for SARS-CoV-2 and within 10 days of symptom onset.
Patients with COVID-19 at high risk for severe progression include: the elderly (> 65 years old), have underlying medical conditions such as hypertension, cardiovascular disease or chronic obstructive pulmonary disease, diabetes mellitus, insufficiency. chronic kidney disease, immunodeficiency disease, cancer, obesity, children with conditions: congenital/acquired heart disease or sickle cell disease or neurodevelopmental disorders such as cerebral palsy, asthma or airway disorder.

Ronapreve may cause allergic reactions or reactions after infusion or injection including: serious hypersensitivity reactions, including anaphylaxis. If signs or symptoms of hypersensitivity occur, you should immediately stop taking the drug and notify your doctor. In addition, possible but uncommon signs and symptoms of other infusion reactions include: fever, chills, nausea, headache, rash, urticaria, pruritus, myalgia and/or dizzy.
In patients with severe COVID-19 the benefit of treatment with Ronapreve has not been established in hospitalized patients. Monoclonal antibodies such as casirivimab and imdevimab may lead to worse clinical outcomes when administered to critically ill patients requiring HFNC high-flow oxygen support or mechanical ventilation.
Finally, it should be noted that the use of the drug Ronapreve does not replace immunotherapy with Covid-19 vaccination. Therefore, everyone needs to be vaccinated according to regulations, including those who have been infected with Covid-19.