Vaccine aside, until yesterday it was the only drug used for the prevention of Sars-Cov-2 infection in high-risk people. Evusheld, a combination of two monoclonal antibodies (Tixagevimab – Cilgavimab), in recent months has represented a support in the prophylaxis of immunocompromised people.
From now on, however, its field of action will expand. The technical-scientific commission of the Italian Medicines Agency has in fact authorized its use also as a therapy. The mix of the two antibodies developed by AstraZeneca can be used – again on patients at risk of developing severe forms of Covid – to treat Sars-CoV-2 infection in the early stages.
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An extra care opportunity
With this decision, through the publication of the determination in the Official Gazette, Aifa therefore broadens the range of therapeutic options available to patients struggling with Covid. The administration, intramuscularly, must in any case take place in the first hours from the detection of the infection.
And, in the intentions of the regulatory agency, it will be reserved for all those cases in which the prescription of antiviral drugs (Paxlovid, Molnupiravir and Remdesivir) and authorized monoclonal antibodies (bamlanivimab, the mix casirivimab-imdevimab and sotrovimab) “is considered inappropriate by the clinical or epidemiological point of view, in relation to the circulation of viral variants “.
Long overdue decision
A decision long overdue by the scientific community. “Today we finally see the indications for the use of Evusheld broadened – he says Claudio Mastroianni, Professor of Infectious Diseases at the Sapienza University of Rome and President of the Italian Society of Infectious and Tropical Diseases (SIMIT) -. Initially it was necessary to have a negative serological test to access the combination of the two monoclonals. The most important discriminant to use is instead the risk factor of the individual patient. The finding of an antibody titer does not ensure either the presence of neutralizing antibodies, nor the certainty of the serum activity on the circulating variant “.
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Enhanced protection
The two monoclonal antibodies that make up Evusheld act by binding to the Coronavirus spike protein and thus preventing its entry into cells. A mechanism of action different from that of vaccines – they prevent the replication of Sars-CoV-2 in the body – and which can be useful precisely in cases where immunological prophylaxis is not recommended or is not sufficient. A scenario that can arise when dealing with immunocompromised people (such as cancer and oncohematological patients), those who have undergone a transplant and anyone who takes immunosuppressive drugs.
Tripled the duration of action
People at increased risk of exposure to the Sars-CoV-2 virus could also benefit from the protection with the combination of antibodies. In addition to strengthening the defenses in the most fragile subjects, Evusheld has the advantage of a long half-life that triples the duration of its action compared to conventional antibodies. Up to six months.
“The combination of the two monoclonal antibodies has been shown to reduce the risk of developing symptomatic Covid compared to placebo by 83% – he explains Giovanni Di Perri, head of the university division of infectious diseases of the Amedeo di Savoia hospital in Turin -. A confirmed benefit also in case of contagion with the latest evolutions of the Omicron variant “.
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Few injections administered
The combination of the two antibodies has so far been used in patients over 12 years old (and weighing at least 40 kilos), non-positive and at least two weeks after vaccination. There are two intramuscular administrations planned, to be carried out in a single session. A repeatable treatment after six months, in case of prolonged infectious risk. The possible target audience will not change with therapeutic use.
There are no official data, but listening to the voice of the clinicians, pre-exposure prophylaxis has been guaranteed to a few thousand Italians. Now, with the latest step taken by Aifa, the hope is to see the use of Evusheld grow as well as all the other drugs available today to fight Covid.