Epidemiologic Characteristics Determining the Choice ofDirect-Acting Antiviral Therapy in HCV Patients: An Italian Real-World Evidence Study
AbstractPangenotypic direct-acting antivirals (pDAAs) have transformed hepatitis C virus (HCV) treatment. In Italy, sofosbuvir/velpatasvir (SOF/VEL) and glecaprevir/pibrentasvir (GLE/PIB) are available. While both show similar efficacy, differences in patient profilesand potential drug–drug interactions (DDIs) may influence treatment choice. This study examined factors affecting pDAA selection and potential prescribing gaps. Using administrative databases (2018–2023) covering 3.7 million… Read More »Epidemiologic Characteristics Determining the Choice ofDirect-Acting Antiviral Therapy in HCV Patients: An Italian Real-World Evidence Study
Characteristics, therapeutic pathway and the economicburden of patients with drug-resistantepilepsy: A real-world analysis following the introduction of cenobamate inItaly
Abstract Objectives: Drug-resistant epilepsy (DRE) remains a major clinical challenge, affecting approximately one-thirdof patients with epilepsy. Cenobamate, a novel antiseizure medication (ASM) approved in Italy in 2022, has shown promisein clinical trials. However, real-world data on its use, especially economic evaluations, remain limited. This analysis assessed the impact of cenobamate in Italian clinical practice, focusing… Read More »Characteristics, therapeutic pathway and the economicburden of patients with drug-resistantepilepsy: A real-world analysis following the introduction of cenobamate inItaly
A Real-World Analysis of the Population with Hepatitis C Virus Infection Affected by Type 2 Diabetes in Italy: Patients’ Characteristics, Comorbidity Profiles and Treatment Patterns
Background and Objectives: HCV infection represents a main risk factor for type 2 diabetes (T2D). This real-world analysis investigated the HCV-positive (HCV+) population with a T2D co-diagnosis in Italy. Methods: From 2017 to 2021, HCV+ patients were identified from administrative databases and stratified into T2D-HCV+ and HCV+-only cohorts in the presence/absence of a T2D diagnosis. Both cohorts were further divided by treatment with direct-acting antivirals (DAAs). The subgroups were compared for demographic variables, comorbidity profiles, most frequent hospitalizations, and drug prescriptions before inclusion. A sensitivity analysis was performed on patients included after 2019, the year of widespread use of pangenotypic DAAs. Results: Considering HCV+ patients aged ≥55 years, T2D-HCV+ patients (N = 1277) were significantly (p < 0.001) older than HCV+-only (N = 6576) ones and burdened by a worse comorbidity profile (average Charlson index: 1.4 vs. 0.3, p < 0.05). Moreover, regardless of T2D presence, DAA-treated patients were older (p < 0.001) and had a worse Charlson index than the untreated ones. T2D-HCV+ patients showed tendentially higher hospitalization rates and co-medication prescriptions compared to the HCV+-only patients. After 2019, a trend towards reduced co-medication use in DAA-treated patients was noticed, especially antibiotics and cardiovascular drugs. Conclusions: The co-presence of T2D in HCV+ patients resulted in a worse clinical status, as confirmed by the more frequent requirement of hospitalizations and complex polypharmacy regimens
Demographics and Clinical Burden of Disease Among RSV-Hospitalized Older Adults in Italy: A Retrospective Cohort Study
Respiratory syncytial virus (RSV) is a leading cause of acute respiratory infection and can lead to severe disease in older adults or those with comorbidities. This analysis aims to evaluate the demographic and clinical burden of RSV hospitalizations among older adults in Italy and inform potential preventative strategies. Adults aged ≥50 years with ≥1 hospitalization discharge diagnosis for RSV from 2010 to 2021 were included. Demographic characteristics before the first RSV hospitalization and clinical outcomes during this hospitalization and the 12 months following are described. Of the 243 patients, mean (SD) age was 73.7 (13.1) years, 40.7% were male, and the most common comorbidities were chronic obstructive pulmonary disease (37.9%), diabetes (21.8%), and heart failure (15.2%). Mean length of index hospitalization was 17.0 days, during which 9.1% of patients died. At index or during the 12-month follow-up, 5.8% had an intensive care unit admission, 61.3% were prescribed antibiotics, 8.2% had a stroke, and 3.3% had an acute myocardial infarction. During the 12-month follow-up, approximately, half of patients experienced worsening of preexisting comorbidities, with notable rates of re-hospitalization and mortality (44.4% and 29.6%). This study shows a high clinical burden of RSV among older adults in Italy, emphasizing a need for improved RSV surveillance, and may guide policymakers and healthcare providers in making informed recommendations for, and implementation of, RSV vaccination in Italy.
Drug Utilization of Rifaximin-α in Patients with Hepatic Encephalopathy: Evidence from Real Clinical Practice in Italy
Background and Objectives: This analysis described rifaximin utilization in Italian patients with hepatic encephalopathy (HE). Although rifaximin is effective in preventing HE relapses, therapeutic management and prescriptive attitudes might be improved. Materials and Methods: Between Oct-2020 and Sep-2021, approximately 12.7 million citizens, patients hospitalized for HE, were identified through the ICD-9-CM code 572.2. Among those discharged alive, utilization of rifaximin 550 mg vs. rifaximin 200 mg for two months post-admission was compared. Results: Of 634 patients hospitalized for HE, 447 (70.5%) were discharged alive. In the two following months, 276 (61.7%) received rifaximin, of whom 117 (26.2%) received rifaximin 550 mg (two daily tablets) and 159 (35.6%) received rifaximin 200 mg (six daily tablets); among 171 patients without rifaximin, 56 (32.7%) received lactulose/lactitol. One year after rifaximin initiation, patients on rifaximin 550 mg (vs. 200 mg) were more frequently persistent (i.e., did not interrupt therapy) (78.6% vs. 46.9%, p < 0.001), showed a lower switching proportion (21.4% vs. 40.7%, p < 0.050), and had a mean monthly dose closer to the recommendations of 36,000 mg/month (~33,000 mg/month vs. 11,629 mg/month, respectively). Conclusions: This analysis suggests suboptimal rifaximin utilization for HE management. Although rifaximin 550 mg is the only formulation with specific indication and reimbursability to prevent HE relapses in Italy, rifaximin 200 mg is more largely used. The need to improve rifaximin prescribing choices is supported by higher persistence, lower switching rates, and average doses aligned to recommendations in patients treated with rifaximin 550 mg.
The Economic Burden of Herpes Zoster in Individuals Aged 50 Years or Older and Those With Underlying Conditions in Italy
Background: Risk of herpes zoster (HZ) infection increases with age and immunosuppression. We estimated the impact of HZ and post-herpetic neuralgia (PHN) on direct costs and health care resource utilization (HCRU) in patients ≥50 years, including those with comorbidities, as limited information exists in Italy.
Methods: This retrospective analysis used reimbursement data from local health authorities in Italy (January 2009-June 2022). Cases of HZ and PHN identified by International Classification of Diseases, Ninth Revision, Clinical Modification codes and drug prescriptions were characterized and followed up for 1 year before and after the index date. The direct HCRU costs for patients with HZ/PHN were compared with those for patients without HZ/PHN.
Results: Of the total 193 259 patients with HZ/PHN identified (mean age, 61.6 years), 145 923 were ≥50 years old (immunocompromised: 29.9%; ≥1 chronic condition: 76.1%). During follow-up, 18.8% of patients ≥50 years of age with HZ progressed to PHN complications, and 3618 hospital admissions were reported (median length of stay, 9 days). Drug prescriptions and all-cause hospitalizations were the main contributors to total annual direct health care costs, estimated at M€272 for patients with HZ/PHN, whose burden increased with age. Higher health care costs were observed in patients with HZ/PHN vs patients without HZ/PHN. Moreover, average health care costs were up to 4× higher for patients with HZ and PHN compared with those without PHN.
Conclusions: HZ causes a significant economic impact on the health care system, driven mainly by high costs of medications and hospitalizations among older adults and those with comorbidities, particularly when complicated by PHN.
Differential Adherence to Free and Single‑Pill Combination of Rosuvastatin/Ezetimibe: Findings from a Real‑World Analysis in Italy
Abstract Introduction Adherence to cardiovascular drug treatment can significantly benefit from a reduced pill burden, but data on this matter derived from real-life settings are currently scanty. This analysis assessed the possible changes in adherence in patients treated with rosuvastatin and ezetimibe (ROS/EZE) as free multi-pill combination who switched to ROS/EZE as single-pill combination in… Read More »Differential Adherence to Free and Single‑Pill Combination of Rosuvastatin/Ezetimibe: Findings from a Real‑World Analysis in Italy
Analisi del percorso terapeutico e del consumo di risorse sanitarie in pazienti diabetici in trattamento insulinico: uno studio di real-world evidence su un campione di ASL della regione Sicilia
Italian reports indicate that more than one-third of patients with type 2 diabetes (T2D) require insulin therapy within 8 years of diagnosis, and commonly basal insulin represents the frontline option. An observational analysis was conducted with the aim of investigating patients treated with basal insulin alone in a sample of Local health Units of Sicily… Read More »Analisi del percorso terapeutico e del consumo di risorse sanitarie in pazienti diabetici in trattamento insulinico: uno studio di real-world evidence su un campione di ASL della regione Sicilia
Profile, Healthcare Resource Consumption and Related Costs in ANCA-Associated Vasculitis Patients: a Real-World Analysis in Italy
Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV) are rare autoimmune diseases triggeringinflammation of small vessels. This real-world analysis was focused on the most common AAV forms, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), to describe patients’ demographic and clinical characteristics,therapeutic management, disease progression, and the related economic burden. A retrospective analysis was conducted on administrative… Read More »Profile, Healthcare Resource Consumption and Related Costs in ANCA-Associated Vasculitis Patients: a Real-World Analysis in Italy
Burden of Illness in Follicular Lymphoma with Multiple Lines of Treatment, Italian RWE Analysis
This real-world analysis investigated patients with follicular lymphoma in Italy receivingthree or more treatment lines (3L), focusing on therapeutic pathways with their rebounds onhealthcare resource consumptions and costs. Data were retrieved from administrative databases fromhealthcare entities covering about 13.3 million residents. Adults diagnosed with follicular lymphomawere identified between January 2015 and June 2020, and among… Read More »Burden of Illness in Follicular Lymphoma with Multiple Lines of Treatment, Italian RWE Analysis