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Registry changes - COVID-19 monoclonal antibodies
Users of the Drug Registers subject to Monitoring are hereby informed that, following the publication of AIFA Determination n.911 in GU n.187 of 06.08.2021, starting from 07/08/2021 it is also possible to use the monoclonal antibody sotrovimab, for the following therapeutic indication:
"Treatment of mild or moderate coronavirus disease 2019 (COVID-19), in adults and adolescents aged 12 years and older not hospitalized for COVID-19, who do not require supplemental oxygen therapy for COVID-19 and who are high risk of severe progression to COVID-19 ".
Furthermore, in implementation of AIFA Determination n.912, it is possible to use the combination casirivimab + imdevimab at a dosage of 4.000mg + 4.000mg in the following therapeutic indication:
"Treatment of patients hospitalized for COVID-19, including on supplemental oxygen therapy (with the exclusion of high-flow oxygen therapy, or on mechanical ventilation), with negative serology for SARSCoV-2 anti-Spike IgG antibodies".
Attention is drawn to the fact that the anti-SARS-CoV-2 monoclonal antibodies currently available, despite having overlapping indications for use, differ from each other, on the basis of recent literature evidence, for their ability to neutralize the different variants. circulating. All anti-SARS-CoV-2 antibodies available in Italy (bamlanivamb / etesevimab, casirivimab / imdevimab and sotrovimab) maintain adequate antiviral activity against alpha (lineage B.1.1.7) and delta (lineage B.1.617. 2), while the neutralizing activity of the bamlanivamb / etesevimab combination, unlike the other available monoclonal antibodies (casirivimab / imdevimab and sotrovimab), is strongly inhibited against the beta (B.1.351) and gamma (P.1) variants. Therefore, where genotyping / sequencing has not been performed, and taking into account the epidemiological context of reference, monoclonal antibodies that are currently effective on all variants (casirivimab / imdevimab and sotrovimab) are to be considered preferable.
(To check the variants of SARS-Cov2 circulating in Italy, consult the periodic reports of the ISS available at the following link: https://www.iss.it/cov19-cosa-fa-iss-varianti)
In conclusion, doctors are reminded that the prescriptions of monoclonal antibodies relating to the authorized indication must be carried out in accordance with the eligibility and prescriptive appropriateness criteria reported in the clinical file, downloadable in .zip format, from the list of "Active Registers and PTs", reachable from the "Related links" box.
Finally, it is specified that, starting from 10/08/2021, the register in question, modified, is available on the web platform; therefore, taking into account the availability of new products, regional representatives are invited to proceed with the qualification of authorized health facilities by accessing the system.
Monitoring Records Office