BackWHO panel gives go-ahead for monoclonal antibody therapy on two covid categories
The treatment combining the antibodies casirivimab and imdevimab has been recommended for two specific groups of patients with covid-19 by a WHO Guideline Development Group panel of international experts
PremiumNEW DELHI : A World Health Organization (WHO) panel on Friday gave its green signal to monoclonal antibodies therapy for management of two categories of covid-19 patients. A treatment combining two antibodies (casirivimab and imdevimab) is recommended for two specific groups of patients with covid-19 by a WHO Guideline Development Group (GDG) panel of international experts. Casirivimab and imdevimab are monoclonal antibodies that when used together bind to the SARS-CoV-2 spike protein, neutralizing the virus’s ability to infect cells.
The panel recommended it for patients with non-severe covid-19, who are at highest risk of hospitalization and those with severe or critical covid-19 who are seronegative, meaning they have not mounted their own antibody response to covid-19.
The study on which the recommendations were made was also published in the British Medical Journal (BMJ). The first recommendation is based on new evidence from three trials that have not yet been peer reviewed, but show that casirivimab and imdevimab probably reduce the risk of hospitalization and duration of symptoms in those at highest risk of severe disease, such as unvaccinated, older, or immunosuppressed patients.
This second recommendation is based on data from the RECOVERY trial showing that casirivimab and imdevimab probably reduce deaths (ranging from 49 fewer per 1,000 in the severely ill to 87 fewer in the critically ill) and the need for mechanical ventilation in seronegative patients.
For all other covid-19 patients, any benefit of this antibody treatment is unlikely to be meaningful. The recommendations are part of a living guideline, developed by the WHO with the methodological support of MAGIC Evidence Ecosystem Foundation, to provide up to date, trustworthy guidance on the management of covid-19 and help doctors make better decisions with their patients.
The panel acknowledged several cost and resource implications associated with this treatment, which may make access to low- and middle-income countries challenging. For example, rapid serological tests will be needed to identify eligible patients who are severely ill, treatment must be given intravenously using specialist equipment, and patients should be monitored for allergic reactions.
They also recognize the possibility that new variants may emerge in which casirivimab and imdevimab antibodies may have reduced effect. However, they said, given the demonstrated benefits for patients, “the recommendations should provide a stimulus to engage all possible mechanisms to improve global access to the intervention and associated testing".
The updated guidance from WHO added to previous recommendations for the use of interleukin-6 receptor blockers and systemic corticosteroids for patients with severe or critical covid-19; and against the use of ivermectin and hydroxychloroquine in patients with covid-19 regardless of disease severity.
In February, the US Food and Drugs Administration (FDA) issued an emergency use authorization (EUA) to the antibody cocktail for the treatment of mild to moderate covid-19 patients. Following this, India also approved the same for management of covid-19 patients.
The WHO also urged producing companies and governments to address the high price and limited production of the Regeneron antibody combination and ensure safe and appropriate handling of the medicine.
Given the high cost and low availability of the combination therapy, UNITAID is negotiating with Roche Pharmaceutical, which is currently manufacturing the drug for lower prices and equitable distribution across all regions, especially in low- and middle-income countries. WHO is also in discussions with the company for a donation and distribution of the drug through UNICEF, following an allocation criteria set by WHO, the global public health agency said in a statement.
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