Publications by authors named "Roberto Di Virgilio"

Introduction: Respiratory Syncytial Virus (RSV) is a leading cause of severe lower respiratory tract infections and is one of the primary causes of hospitalization in high income countries and death among children aged ≤ 1 year in lower income countries where the healthcare systems not always have the resources to provide appropriate intensive care to all infants with severe RSV infection. On the basis of the results of a large programme of clinical trials, the European Medicine Agency has recently approved a Bivalent Stabilized Prefusion F Subunit Vaccine (RSVpreFV) for maternal immunization, with a year-round administration between 24-36 weeks of gestation. The objective of the study is providing an estimation of the efficiency of complementary strategy RSVpreF and monoclonal antibodies for the prevention of RSV among Italian infants.

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Background: Streptococcus pneumoniae represents a significant global public health threat, causing approximately 45 million lower respiratory tract infections and 350,000 deaths annually among children under 5 years of age. Conjugate pneumococcal vaccines (PCVs), such as PCV15 and PCV20, have been developed to mitigate this burden by providing protection against serotypes responsible for the disease. The present analysis aims to evaluate the cost-utility of PCV20 compared to PCV15 as a vaccination strategy for preventing pneumococcal diseases in children in Italy.

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Article Synopsis
  • Duchenne muscular dystrophy (DMD) is a progressive genetic disorder that currently has no cure, and its management relies on physiotherapy and medications to slow progression.
  • Gene therapy presents a promising treatment option but requires a well-organized delivery system, such as the hub-and-spoke model, to effectively support DMD patients in Italy.
  • A study mapped existing DMD centers in Italy, evaluated their readiness for gene therapy, and identified areas for improvement, ultimately proposing a flexible organizational model to enhance patient care.
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Objective: This study is describing subjects with migraine interrupting or not receiving triptans for acute treatment and providing a national-level estimate of people who might benefit from different therapeutic approaches.

Methods: This is a retrospective analysis using IQVIA Longitudinal Patient Database. Starting from 18 + years old individuals with migraine, we selected two cohorts: subjects with triptans prescriptions before and no triptans prescriptions after Index Date (triptan withdraw) and subjects without triptans prescriptions both before and after Index Date (no triptan prescriptions).

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Background: Based on the results from the ALFA-0701 study, gemtuzumab ozogamicin (GO) has been approved by the European Medicine Agency and by the Italian Drug Agency for the first line treatment of de novo acute-myeloid leukemia (AML). In this analysis, we assessed the cost-effectiveness of GO in combination with daunorubicin and cytarabine (DA), vs DA alone, adopting the perspective of the Italian National Health Service.

Methods: For this analysis, a cohort state transition model was developed.

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Article Synopsis
  • - The study assesses the cost-effectiveness of a new 20-valent pneumococcal conjugate vaccine (PCV) in Italy, using a Markovian model from the Italian National Health Service perspective, comparing it to 13-valent and 15-valent PCVs.
  • - Results show that the 20-valent PCV is more effective and cheaper, reducing disease events significantly, leading to a gain of over 6,500 life years and nearly 4,800 quality-adjusted life years (QALYs). Cost savings amount to EUR 7.464 million despite an increase in vaccination costs.
  • - The analysis concludes that transitioning to the 20-valent PCV is a sustainable and efficient investment,
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Objectives: This systematic review aims to describe 1) the epidemiology of the diseases indicated for treatment with growth hormone (GH) in Italy; 2) the adherence to the GH treatment in Italy and factors associated with non-adherence; 3) the economic impact of GH treatment in Italy; 4) the quality of life of patients treated with GH and their caregivers in Italy.

Methods: Systematic literature searches were performed in PubMed, Embase and Web of Science from January 2010 to March 2021. Literature selection process, data extraction and quality assessment were performed by two independent reviewers.

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Purpose: Ceftazidime/avibactam (CAZ-AVI) is a fixed-dose combination antibiotic approved in Europe and the United States for patients with hospital-acquired pneumonia, including ventilator-associated pneumonia (HAP/VAP). The economic benefits of a new drug such as CAZ-AVI are required to be assessed against those of available comparators, from the perspective of health care providers and payers, through cost-effectiveness and cost-utility analyses. The objective of this analysis was to compare the cost-effectiveness of CAZ-AVI versus meropenem in the empirical treatment of appropriate hospitalized patients with HAP/VAP caused by gram-negative pathogens, from the perspective of publicly funded health care in Italy (third-party perspective, based on the data from the REPROVE (Ceftazidime-Avibactam Versus Meropenem In Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia) clinical study; ClinicalTrials.

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: Invasive and non-invasive pneumococcal diseases are significant health and economic burdens, especially in children and the elderly. Italy included the 7-valent (PCV7) and 13-valent pneumococcal conjugate vaccine (PCV13) in the National Immunization Program in 2007 and 2010, respectively, allowing a dramatic reduction in the burden of pneumococcal disease. In the era of budget constraints, decision-makers may consider switching from the higher-valent, more costly PCV13, to the lower-cost PCV10.

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Background: The rising incidence of resistance to currently available antibiotics among pathogens, particularly Gram-negative pathogens, in complicated intra-abdominal infections (cIAIs) has become a challenge for clinicians. Ceftazidime/avibactam (CAZ-AVI) is a fixed-dose antibiotic approved in Europe and the United States for treating (in combination with metronidazole) cIAI in adult hospitalised patients who have limited or no alternative treatment options. The approval was based on the results of RECLAIM, a Phase III, parallel-group, comparative study (RECLAIM 1 [NCT01499290] and RECLAIM 2 [NCT01500239]).

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Ceftazidime/avibactam (CAZ-AVI) is a novel, fixed-dose combination antibiotic that has been approved in Europe and the United States for patients with complicated urinary tract infections (cUTIs) based on results of a Phase III, randomized, comparative study (RECAPTURE study). The present analysis evaluated cost-effectiveness of CAZ-AVI as an empirical treatment for hospitalized patients with cUTIs from the Italian publicly funded healthcare (third-party payer) perspective. A sequential, patient-level simulation model was developed that followed the clinical course of cUTI and generated 5000 pairs of identical patients (CAZ-AVI or imipenem as empirical treatment).

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  • The study aimed to explore how Atorvastatin therapy affects osteoprogenitor cells and RANKL expression in immune cells, factors linked to osteoporosis and vascular calcification in postmenopausal women with high cholesterol.
  • After 3 months on Atorvastatin, participants showed significant decreases in total cholesterol and LDL-C, alongside increased levels of OPG and reduced RANKL expression in T cells, suggesting positive changes in bone health markers.
  • The findings indicate that statins may offer protective benefits in the bone-vascular connection by lowering circulating osteoprogenitor cells and enhancing OPG levels, highlighting their potential in osteoporosis treatment.
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The main clinical presentation of osteoporosis is fracture and its consequences. However a number of diseases and factors can induce bone loss and increase the risk of fracture. Therefore the clinical approach should be initially directed to exclude secondary osteoporosis.

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BACKGROUND: Depression is one of the most ancient and common diseases of the human race and its burden on society is really impressive. This stems both from the epidemiological spread (lifetime prevalence rate, up to 30 years of age, was estimated as greater than 14.4% by Angst et al.

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