Antonio Izzi

Ospedale D. Cotugno

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Umberto Vespasiani‐Gentilucci

Università Campus Bio-Medico

Valeria Pace Palitti

Azienda USL di Pescara

Raffaele Cozzolongo

Gastroenterology Hospital "Saverio de Bellis"

Vincenzo Messina

Ospedale Sant'Anna

Maurizio Russello

Ospedale Garibaldi

Rodolfo Sacco

University of Foggia

Marco Distefano

Ospedali Riuniti Umberto I

Ernesto Claar

Villa Pineta Hospital

Gaetano Scifo

Azienda Ospedaliero-Universitaria Policlinico - Vittorio Emanuele

Luca Rinaldi

University of Molise

Cooperative Institutions

Istituti di Ricovero e Cura a Carattere Scientifico

169

University of Campania "Luigi Vanvitelli"

131

Italian Medicines Agency

129

University of Naples Federico II

Sapienza University of Rome

University of Milano-Bicocca

University of Milan

Université Libre de Bruxelles

Center for Disease Analysis

Azienda Ospedaliera San Gerardo

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Assessment of Response and Safety of Bulevirtide Treatment in Patients with Chronic Delta Virus Infection: The ARISTOTLE Pilot Observational Study

Viruses (2025)

Luca Rinaldi Mauro Viganò Alessia Ciancio Alfredo Caturano Vincenzo Messina

Introduction: Hepatitis D virus (HDV) infection remains a significant global health challenge due to its severity and high risk of progression to cirrhosis and hepatocellular carcinoma (HCC). Bulevirtide, a novel HDV entry inhibitor, has shown promise in managing chronic hepatitis D by blocking viral entry into hepatocytes. This study evaluated the efficacy and safety of bulevirtide in reducing HDV RNA levels and improving liver function in a real-life cohort of Italian patients with HDV infection. Methods: This multicenter prospective trial enrolled 108 consecutive patients with chronic HDV infection, from June 2023 to June 2024, who received 2 mg/day of bulevirtide in combination with a nucleoside/nucleotide analogue for hepatitis B virus (HBV) infection. Patients with any stage of liver fibrosis or compensated cirrhosis were included. Data collected included demographic and clinical characteristics, liver function tests, HDV RNA levels, and adverse events at baseline and 6 months. Results: The virological response was achieved in 54.6% of patients (n = 59), with 36 demonstrating undetectable HDV RNA levels. Among responders, ALT levels decreased significantly from 67.0 U/mL [IQR 44.0–116.3] to 31.5 U/mL [IQR 24.0–36.5, p = 0.001], and AST levels from 66.0 U/mL [IQR 46.5–91.0] to 32.5 U/mL [IQR 28.0–38.0, p = 0.021]. Median HDV RNA dropped from 29,800 IU/mL [IQR 3100–375,000] to 0 IU/mL [IQR 0–291, p < 0.001]. No significant predictors of response emerged. Mild adverse events, including pruritus (5.6%) and injection-site reactions (1.9%) and flu-like syndrome (0.9) were reported, with no treatment discontinuation. Conclusions: Bulevirtide effectively reduces HDV RNA levels and improves liver function with a favorable safety profile, offering a promising therapeutic option for chronic hepatitis D. Further large-scale studies are needed to confirm these findings and explore long-term outcomes.

Liver function

Hepatitis D virus

Hepatitis D

Viral Hepatitis

10.3390/v17020251

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Perioperative Management of a Pediatric Patient with Beckwith–Wiedemann Syndrome Undergoing a Partial Glossectomy According to Egyedi/Obwegeser

Children (2023)

Antonio Izzi Vincenzo Marchello Aldo Manuali Lazzaro Cassano Andrea Di Francesco

Here, we report the perioperative management of a clinical case of a 6 year, 5 month old girl suffering from Beckwith–Wiedemann syndrome undergoing a partial glossectomy procedure in a patient with surgical indication for obstructive sleep apnea syndrome (OSAS), difficulty swallowing, feeding, and speech. On surgery day, Clonidine (4 µg/kg) was administered. Following this, a general anesthesia induction was performed by administering Sevoflurane, Fentanyl, continuous intravenous Remifentanil, and lidocaine to the vocal cords, and a rhinotracheal intubation with a size 4.5 tube was carried out. Before starting the procedure, a block of the Lingual Nerve was performed with Levobupivacaine. Analgosedation was maintained with 3% Sevoflurane in air and oxygen (FiO2 of 40%) and Remifentanil in continuous intravenous infusion at a rate of 0.08–0.15 µg/kg/min. The surgical procedure lasted 2 h and 32 min. At the end of the surgery, the patient was under close observation during the first 72 h. In the pediatric patient with Beckwith–Wiedemann syndrome submitted to major maxillofacial surgery, the difficulty in managing the airways in the preoperative phase during intubation and in the post-operative phase during extubation should be considered.

Macroglossia

Beckwith–Wiedemann syndrome

Midazolam

Glossectomy

10.3390/children10091467

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Citations (1)

Safety and efficacy of ombitasvir/paritaprevir/ritonavir/dasabuvir plus ribavirin in patients over 65 years with HCV genotype 1 cirrhosis

Infection (2018)

Antonio Ascione M. De Luca Mario Melazzini Simona Montilla Maria Paola Trotta

Ombitasvir

Paritaprevir

Dasabuvir

Ritonavir

Hepatitis C

10.1007/s15010-018-1157-x

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Citations (8)

The Pharmacological Class Alpha 2 Agonists for Stress Control in Patients with Respiratory Failure: The Main Actor in the Different Acts

Stresses (2022)

Andreaserena Recchia Maria Pia Tonti Lucia Mirabella Antonio Izzi Alfredo Del Gaudio

The role of sedation in patients with acute respiratory failure in the intensive care unit is crucial for improving the adaptation to mechanical ventilation, avoiding lung injury, and reducing stress related to the over-stimulated sympathetic tone. The drug class alpha 2 agonists, alone or in synergic association, can help the clinician achieve these goals. Understanding the principles of pharmacology and applying them to the alpha 2 agonists, clonidine and dexmedetomidine, can lead to different pharmaceutical choices to adapt various sedative approaches to the different stages of acute respiratory failure. A scheme is proposed using these two drugs as a pharmacological continuation for an early weaning and recovery from the intensive care unit.

Dexmedetomidine

Alpha (finance)

Acute respiratory failure

10.3390/stresses3010001

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Citations (1)

Late HCC Occurrence in Patients Achieving SVR after DAAs Therapy: A Matter of Follow-Up or Something Else?

Alessandro Perrella Ilario de Sio Pasquale Bellopede Adelaide Maddaloni Luigi Vitale

The rapid introduction of DAAs has revolutionized the treatment of chronic HCV infection, however some concerns have been arose about their early and long term safety in real life settings. Therefore, these drugs achieve a robust and sustained virological response in a short duration of treatment, being a quick winning option, but, what then? At now an extensive follow-up in real life settings does not exist particularly on HCC occurrence as recently suggested in a Cochrane review . In this regard from February 2015 to December 2017 a group of 5 Hospital and Academic Centers in Southern Italy (Campania Region) managed an observational, prospective, real-life study on efficacy and safety of DAAs treatment schedule enrolling 1022 consecutive HCV patients treated with IFN-free DAAs regimens being followed-up for 24 months. Our preliminary data on the first 360 patients out of 1022 whose completed at least 66 weeks follow-up, based on clinical, laboratory and expert ultrasonography every three months, showed an SVR in 342 out 360 (95%) patients of which 9 had a new diagnosed HCC (2.63%). Specifically HCC developed in mean after 16,2 months after end of treatment as one or more nodules (2-3 cm in mean) with an increase in alpha-fetoprotein 10 x u.n.v (n.v. <15 UI/mL) in patients with F4 fibrosis staging at the time of treatment enrolment. In conclusion, in view of our findings and literature evidences, regular clinical, laboratory and expert ultrasonography follow-up should carefully performed also on these patients and the current Faster, Higher, Stronger approach to the new antivirals development should strongly be revisited in the light of possible late adverse events like HCC occurrence and the relative economic impact on health care system cost.

10.20944/preprints202309.0048.v1

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Citations (1)

The Prognostic Role of Lactate Concentrations after Aneurysmal Subarachnoid Hemorrhage

Brain Sciences (2020)

Narcisse Ndieugnou Djangang Pamela Ramunno Antonio Izzi Alessandra Garufi Marco Menozzi

Blood lactate concentrations are often used to assess global tissue perfusion in critically ill patients; however, there are scarce data on lactate concentrations after subarachnoid hemorrhage (SAH). We aimed to assess the prognostic role of serial blood lactate measurements on hospital mortality and neurological outcomes at 3 months after SAH. We reviewed all SAH patients admitted to the intensive care unit from 2007 to 2019 and recorded the highest daily arterial lactate concentration for the first 6 days. Patients with no lactate concentration were excluded. Hyperlactatemia was defined as a blood lactate concentration >2.0 mmol/L. A total of 456 patients were included: 158 (35%) patients died in hospital and 209 (46%) had an unfavorable outcome (UO) at 3 months. The median highest lactate concentration was 2.7 (1.8–3.9) mmol/L. Non-survivors and patients with UO had significantly higher lactate concentrations compared to other patients. Hyperlactatemia increased the chance of dying (OR 4.19 (95% CI 2.38–7.39)) and of having UO in 3 months (OR 4.16 (95% CI 2.52–6.88)) after adjusting for confounding factors. Therefore, initial blood lactate concentrations have prognostic implications in patients with SAH; their role in conjunction with other prognostic indicators should be evaluated in prospective studies.

Hyperlactatemia

Arterial blood

10.3390/brainsci10121004

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Citations (7)

TOP-085 Final results from the italian real-world experience on lusutrombopag treatment in cirrhotic patients with severe thrombocytopenia: insights from the reality study

Journal of Hepatology (2024)

Paolo Gallo Antonio De Vincentis Valeria Pace Palitti Maurizio Russello Anthony Vignone

10.1016/s0168-8278(24)00776-1

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FRI-067-Management of primary biliary cholangitis in the pre-obeticholic acid era, and the rate of non-response to ursodeoxycholic acid (UDCA), in a large real-world cohort of PBC patients in Italy: The CLEO-AIGO database

Journal of Hepatology (2019)

Umberto Vespasiani‐Gentilucci F. Rosina Luchino Chessa Valeria Pace Palitti Antonio Picardi

Ursodeoxycholic acid

Obeticholic acid

10.1016/s0618-8278(19)30817-5

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Citations (1)

High Efficacy and Safety of Flat-Dose Ribavirin Plus Sofosbuvir/Daclatasvir in Genotype 3 Cirrhotic Patients

Gut and Liver (2019)

Adriano Pellicelli Vincenzo Messina Valerio Giannelli Marco Distefano Valeria Pace Palitti

Adriano Pellicelli, Vincenzo Messina, Valerio Giannelli1, Marco Distefano, Valeria Pace Palitti, Pascal Vignally, Pierluigi Tarquini, Antonio Izzi, Alessandra Moretti, Sergio Babudieri, Serena Dell’Isola, Massimo Marignani, Gaetano Scifo, Vincenzo Iovinella, Giuseppe Cariti, Maurizio Pompili, Francesco Di Candilo, Luca Fontanella, Giuseppe M. Ettorre, Giovanni Vennarecci, Antonio Massimo Ippolito, and Giorgio Barbarini, for the Working Group CLEO. Gut and Liver 2020;14:357-67. https://doi.org/10.5009/gnl18269

Daclatasvir

Sofosbuvir

10.5009/gnl18269

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Citations (10)

Late Hepatocellular Carcinoma Occurrence in Patients Achieving Sustained Virological Response After Direct-Acting Antiviral Therapy: A Matter of Follow-Up or Something Else?

Journal of Clinical Medicine (2024)

Alessandro Perrella Alfredo Caturano Ilario de Sio Pasquale Bellopede Adelaide Maddaloni

Background: Despite achieving a sustained virological response (SVR) with direct-acting antivirals (DAAs), an unexpected increase in the occurrence rate of hepatocellular carcinoma (HCC) has been observed among HCV-treated patients. This study aims to assess the long-term follow-up of HCV patients treated with DAAs who achieved an SVR to investigate the potential for late-onset HCC. Methods: In this prospective multicenter study, we enrolled consecutive HCV patients treated with DAAs following Italian ministerial guidelines between 2015 and 2018. Exclusion criteria included active HCC on imaging, prior HCC treatment, HBV or HIV co-infection, or liver transplant recipients. Monthly follow-ups occurred during treatment, with subsequent assessments every 3 months for at least 48 months. Abdominal ultrasound (US) was performed within two weeks before starting antiviral therapy, supplemented by contrast-enhanced ultrasonography (CEUS), dynamic computed tomography (CT), or magnetic resonance imaging (MRI) to evaluate incidental liver lesions. Results: Of the 306 patients completing the 48-months follow-up post-treatment (median age 67 years, 55% male), all achieved an SVR. A sofosbuvir-based regimen was administered to 72.5% of patients, while 20% received ribavirin. During follow-up, late-onset HCC developed in 20 patients (cumulative incidence rate of 6.55%). The pattern of HCC occurrence varied (median diameter 24 mm). Multivariate and univariate analyses identified liver stiffness, diabetes, body mass index, and platelet levels before antiviral therapy as associated factors for late HCC occurrence. Conclusions: Our findings suggest that late HCC occurrence may persist despite achieving SVR. Therefore, comprehensive long-term follow-up, including clinical, laboratory, and expert ultrasonography evaluations, is crucial for all HCV patients treated with DAAs.

Sofosbuvir

Regimen

Univariate analysis

10.3390/jcm13185474

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