Despite representing only approximately 4% of the total population, 24% of deaths, 22% of hospitalizations and 28% of admissions to intensive care units are made up of immunocompromised patients: these are some of the data that emerged from the Inform study which demonstrated how immunocompromised patients are at greater risk of incurring serious consequences from Covid-19 compared to the general population. From the Italian results recently published by the Higher Institute of Health relating to vaccinated individuals, immunocompromised patients, compared to the population without risk conditions, have an approximately 3 times greater risk of hospitalization related to Covid-19 and a risk of death related to Covid -19 almost 4 times higher. This sub-population of patients has a compromised immune system due to one or more pathologies and is therefore at greater risk of contracting viruses and severe infections and therefore needs to be protected with the available anti-Covid-19 therapeutic options and Pre-Prophylaxis. -Exposure (PrEP) with monoclonal antibodies.
The Prevention Management LAboratory project. To develop guidelines that can simplify the management of PrEP, from the identification to the management of immunocompromised patients, the Prevention Management LAboratory (PMLAb) project was born, conceived by Dephaforum with the support of AstraZeneca Italia. The objective of the project is to propose an organizational model shared at a national level which can, with respect for regional and local autonomies, facilitate the selection and identification of immunocompromised patients potentially eligible for PrEP and increase awareness regarding the importance and to the value of PrEP for Covid-19 with monoclonal antibodies, while working at the same time to build a multidisciplinary network of healthcare professionals that allows us to streamline the process and care of patients. The guidelines relating to the ideal organizational model for Covid-19 PrEP and the care and management of the immunocompromised patient, developed by the cross-functional work of the Working Group and validated during 2023 at regional and local level through the supported by a multidisciplinary team of experts, were presented today during the final national event.
«The SARS-Cov-2 virus continues to circulate, despite the fact that in this endemic phase it is less dangerous for the healthy population than in past years – explains Stefano Vella, professor of Clinical Research Methodology & Global Health, University of Rome Tor Vergata –. This means that today it remains essential to protect immunocompromised patients above all, both those who, despite completing the vaccination cycle, have an immunocompromised condition that does not allow them to develop an adequate immune response, and those who have not been able to get vaccinated for various reasons including your health conditions. From an analysis of the level of antibodies against Sars-CoV-2 in haematological oncology patients who had completed the vaccination cycle against Covid-19, it emerged that 55.3% did not respond to the vaccine. In 2022, 46.8% of patients with end-stage renal disease and 24.6% of hematopoietic stem cell transplant or solid organ transplant recipients who contracted Covid-19 were hospitalized, versus 3.7% of the general population. These data demonstrate the presence of an unmet need and the importance of pre-exposure prophylaxis with monoclonal antibodies as protection for this subpopulation of patients at risk of lack of or reduced response or ineligibility to vaccination and therefore at an increased risk of developing the form severe cases of Sars-CoV-2 infection, Covid-19 related hospitalization and death. The role of the specialist doctor is fundamental in exploring the opportunity offered by monoclonal antibodies in the protection of immunocompromised patients, through information on existing options. At the same time, collaboration with general medicine is equally important in identifying the patient at risk and raising awareness of a discussion with the specialist.
The PMLAb project involved the establishment of a multidisciplinary team of experts who developed a proposal for guidelines relating to the ideal organizational model for Covid-19 PrEP from the intake to the management of the immunocompromised patient. To also track the management of prophylaxis with monoclonal antibodies at a local level, the project included multidisciplinary meetings in various Italian regions in which the proposed guidelines were discussed and validated, in order to create a Consensus Document that took into account both national and regional experience. «For haematological oncology patients undergoing anti-tumor treatment, Covid-19 has represented and still represents a real risk today – says Carmine Pinto, Director of Uoc Medical Oncology, Comprehensive Cancer Center Ausl-Irccs Reggio Emilia -. Therapies often cause immunosuppression which requires greater caution, as the onset of an infection can mean not only hospitalization, death or worsening of the state of health, but also the suspension of treatment, with all the related risks. To reduce the risk of infection, immunocompromised patients still experience an altered daily reality, as the fear of contracting the virus limits their daily activities.” The guidelines developed in cross-functional mode by the Working Group represent the starting point for the construction of an organizational model that simplifies the management of Pre-Exposure Prophylaxis and the care of immunocompromised patients through the creation of a network between specialist doctors for the identification, selection and prioritization of patients thanks also to the collaboration with General Practitioners. The key role in this path is that of the hospital pharmacist, an actor in the coordination and planning of legal activities for the management of PrEP and within the multidisciplinary team, a team which includes, in addition to the infectious disease specialist, also other specialist figures. The experience and knowledge of the infectious disease specialist are therefore also fundamental in terms of training and information of the various specialist figures, as well as of the patients.
«In prevention and prophylaxis activities the organizational component becomes increasingly important, but also the most difficult to manage at a local level, as it requires dedicated analyzes and working groups in which all the components are represented. It is not obvious, in fact, to give substance to the desire to involve patients and professionals in the design and construction phases of the proposal for “ideal” models for taking charge and managing the immunocompromised patient – states Francesca Patarnello, Vice President Market Access & Government Affairs of AstraZeneca Italy –. Our contribution was to support a laboratory, the ‘PMLab’, dedicated to this objective in which concrete indications were studied and discussed to ensure greater and more homogeneous access to existing protection opportunities that were adaptable and modulated on the basis of specific local realities”.
