A combination of antibodies (tixagevimab and cilgavimab) can reduce the risk of developing symptomatic COVID-19. The results of the Provent study published today in the New England Journal of Medicine.
More than 75% of the study participants suffered from various diseases that put them at a high chance of developing severe Covid-19 if they became infected. In fact, immuno-compromised people and people who could have given an inadequate immune response to vaccination were also included, such as chronic lymphatic leukemia patients or others with primary or acquired immunodeficiencies, transplant recipients undergoing immunosuppressive treatments. Importantly, the concentrations of the two antibodies remained elevated in patient serum for six months after administration, supporting the fact that a single dose could provide long-term protection against COVID-19 for at least six months.
“Although vaccines against Covid-19 have been highly effective in reducing hospitalization and death – commented Giovanni Di Perri, Full Professor of Infectious Diseases at the University of Turin and Head of the University Division of Infectious Diseases at the Amedeo Hospital di Savoia di Torino – there are still many people whose individual conditions do not allow a valid protective response to vaccination. These are in particular immunosuppressed individuals and those for whom vaccination is contraindicated. These important data published on the New England Journal of Medicine provide evidence of how a single dose of the easily administered intramuscularly administered monoclonal antibody combination tixagevimab and cilgavimab results in lasting protection. Furthermore, in the rare cases in which the infection occurred despite the administration of the two monoclonals, in no case did it occur in a severe or critical way “.
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There were no cases of severe COVID-19, and COVID-19-related deaths or hospitalizations in the tixagevimab and cilgavimab group in the six-month follow-up analysis; there were five cases of severe illness, seven hospitalizations and two deaths related to COVID-19 in the placebo group.
The combination of tixagevimab and cilgavimab antibodies was generally well tolerated during the PROVENT study and no safety concerns were found in either the primary or six-month analyzes. Adverse events occurred with equal frequency in the tixagevimab and cilgavimab and placebo groups. The most common adverse event was injection site reaction, which occurred in 2.4% of participants in the tixagevimab and cilgavimab group and 2.1% of participants in the placebo group.
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Approximately 2% of the world‘s population is considered to be at high risk of an inadequate response to COVID-19 vaccination and could particularly benefit from pre-exposure prophylaxis with the combination of monoclonal antibodies tixagevimab and cilgavimab. This population includes immunocompromised people, such as those with cancer or transplant patients or anyone taking immunosuppressive drugs. People at high risk of exposure to the SARS-CoV-2 virus could also benefit from protection with thixagevimab and cilgavimab.
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