Three scientific societies together in the fight against Covid for common objectives: to raise awareness among doctors of different specialties, create a shared protocol and set the milestone for an alliance between community doctors and specialist centers, in order to promote timely and more effective treatment of Covid19, in which the use of monoclonal antibodies is strategic. The tool to pursue these goals is the ‘Sars-Cov-2 consensus document: Early Diagnosis and Better Access to Care for Fragile Patients. The need for a coalition between local medicine and specialist centers’, drawn up and signed by the Italian Society of Infectious and Tropical Diseases (Simit), Italian Society of General Medicine and Primary Care (Simg), Italian Society of Hospital Pharmacy (Sifo) and with the contribution of the honorable Angela Ianaro (XII Commission of the Chamber of Deputies of the Republic) and of Cittadinanzattiva.
If vaccines can help stem the progression of the pandemic – the experts explain in a note – to date, monoclonal antibodies represent in fact the only real therapeutic treatment, direct and effective against Sars-Cov-2. There are several types of monoclonals available and just recently Aifa has approved new ones, including sotrovimab, developed by GlaxoSmithKline in collaboration with Vir Biotechnology, which has already been shown to maintain activity against all known combined mutations of the Omicron variant. . Compared to its predecessors, sotrovimab has a longer half-life and improved pulmonary distribution, and has been specifically approved for early treatment of infection with a high risk of hospitalization. The pivotal phase III study on sotrovimab was suspended due to evident efficacy, having in fact resulted in an 85% reduction in hospitalizations or deaths. The addition of new options represents a qualitative improvement as well as of course a quantitative increase: they constitute a resource in the face of the multiplication of variants and a precision medicine tool according to the different frailties.
“To achieve the goal of quickly addressing patients to therapy, the family doctors of Simg, together with the infectious disease specialists of Simit and other specialists, have developed a project to identify vulnerable and fragile patients in order to start a path fast-track to referral centers, which are not only infectious disease centers, but in smaller hospitals are first aid units, internal medicine or pneumology departments. Currently, in fact, monoclonal antibodies can be administered only in hospital, by adequately trained personnel, since an intravenous infusion of one hour is required and an observation phase to follow to detect any adverse reactions “, highlights Pierangelo Lora Aprile, Simg scientific secretary.
Monoclonal antibodies should be used within 3-5 days of the onset of infection. They are used to prevent the pathology from degenerating into its most serious forms: in more than 95% of cases they are able to block the evolution of the picture. They differ from vaccines in that they are antibodies constructed in vitro and are very selectively active against the virus, recognizing a specific antigen of the spike protein against which they are directed, while the vaccine must determine an antibody response within our body.
“The use of monoclonal antibodies – explains Claudio Mastroianni, Simit president – is now a consolidated reality in the treatment of the early stages of infection in those subjects who have a high risk of developing a severe progression of the disease. The early administration is fundamental. should preferably occur within 3-5 days from the onset of symptoms. Monoclonal antibodies represent a therapy with a great impact in avoiding hospitalization, one of the most devastating consequences of Covid. A strategy of possible future application is the use as a prophylaxis pre- and / or post-exposure in subjects who have not completed the vaccination course or who are not expected to develop an adequate immune response to the vaccine, such as immunosuppressed persons “.
“Monoclonal antibodies are an important pharmacological weapon of the NHS in the fight against the virus”, is the comment of Arturo Cavaliere, national president of Sifo, “It is a tool that complements the prevention rules and vaccines to face the emergency Covid-19 which since February 2020 has been putting our country (and the whole world) in a situation of unprecedented social uncertainty and health pressure. We are sure that the NHS will be able to offer citizens the opportunity to use, also thanks to hospital pharmacists , this new important weapon against Sars-Cov-2 with precision, efficacy and punctuality. Hospital pharmacists, as per their competence and responsibility, are the backbone together with specialists and general practitioners, both of the overall management of antibodies monoclonal and pharmacovigilance mechanisms, connecting with regional networks, promptly providing all the data and elements necessary to ensure urate a correct and safe management of drugs “.
The use of monoclonal antibodies concerns non-hospitalized patients, over 12 years, not on oxygen therapy and who present a risk of severe disease. “The clinical conditions that the patient of Sars-cov 2 must present in order to be entitled to therapy with monoclonal antibodies have been defined by the Health Authorities”, underlines Pierangelo Lora Aprile.
“It is crucial – he continues – to promptly identify these subjects and start them with fast track procedures at the reference centers. The general practitioner can immediately check whether the patient with suspicion of Sars-Cov 2 disease is included among the vulnerable subjects and / or fragile. Vulnerability refers to a risk condition for the specific Sars Cov-2 disease, while frailty is linked to the presence of multiple deficits that generally affect a greater risk in the case of disease. Simg through its Research School has developed vulnerability and fragility indicators (HS Vulnerability Index – HX Frailty Index) that make it easier to identify the subjects to whom the utmost attention is to be paid and, in the case of an ascertained Covid infection, check for the presence of the necessary requirements to access treatment ” .
“The rapid control of patients must then be followed by immediate access to the reference centers on the territory. The responsible specialist will have to define, according to the characteristics of the patient, the best therapy and start the treatment necessary in that specific circumstance”, concludes Lora Aprile.