{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T19:23:31Z","timestamp":1791401011075,"version":"4.3.3"},"reference-count":45,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2025,2,12]],"date-time":"2025-02-12T00:00:00Z","timestamp":1739318400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>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\u2013116.3] to 31.5 U\/mL [IQR 24.0\u201336.5, p = 0.001], and AST levels from 66.0 U\/mL [IQR 46.5\u201391.0] to 32.5 U\/mL [IQR 28.0\u201338.0, p = 0.021]. Median HDV RNA dropped from 29,800 IU\/mL [IQR 3100\u2013375,000] to 0 IU\/mL [IQR 0\u2013291, p &lt; 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.<\/jats:p>","DOI":"10.3390\/v17020251","type":"journal-article","created":{"date-parts":[[2025,2,12]],"date-time":"2025-02-12T08:05:42Z","timestamp":1739347542000},"page":"251","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Assessment of Response and Safety of Bulevirtide Treatment in Patients with Chronic Delta Virus Infection: The ARISTOTLE Pilot Observational Study"],"prefix":"10.3390","volume":"17","author":[{"given":"Luca","family":"Rinaldi","sequence":"first","affiliation":[{"name":"Department of Medicine and Health Sciences \u201cVincenzo Tiberio\u201d, Universit\u00e0 degli Studi del Molise, 86100 Campobasso, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0769-1767","authenticated-orcid":false,"given":"Mauro","family":"Vigan\u00f2","sequence":"additional","affiliation":[{"name":"Gastroenterology, Hepatology and Transplantation Division, ASST Papa Giovanni XXIII, 24127 Bergamo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4188-0609","authenticated-orcid":false,"given":"Alessia","family":"Ciancio","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences, University of Turin, 10124 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7761-7533","authenticated-orcid":false,"given":"Alfredo","family":"Caturano","sequence":"additional","affiliation":[{"name":"Department of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, Italy"},{"name":"Department of Human Sciences and Promotion of the Quality of Life, San Raffaele Roma Open University, 00166 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincenzo","family":"Messina","sequence":"additional","affiliation":[{"name":"Infectious Diseases Unit, Sant\u2019Anna e San Sebastiano Hospital, 81100 Caserta, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Grazia Anna","family":"Niro","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, IRCCS Casa Sollievo della Sofferenza, 71013 San Giovanni Rotondo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolina","family":"Capoluongo","sequence":"additional","affiliation":[{"name":"Department of Emergency Infectious Diseases and Infectious Diseases, Ospedali dei Colli, P.O.D. Cotugno, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8022-8803","authenticated-orcid":false,"given":"Alessandro","family":"Loglio","sequence":"additional","affiliation":[{"name":"Gastroenterology, Hepatology and Transplantation Division, ASST Papa Giovanni XXIII, 24127 Bergamo, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Letizia","family":"Marinaro","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences, University of Turin, 10124 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aldo","family":"Marrone","sequence":"additional","affiliation":[{"name":"Department of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ernesto","family":"Claar","sequence":"additional","affiliation":[{"name":"Department of Medicine, Ospedale Evangelico Villa Betania, 80147 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurizio","family":"Russello","sequence":"additional","affiliation":[{"name":"Liver Unit, ARNAS Garibaldi Nesima, 95124 Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emanuela","family":"Cirac\u00ec","sequence":"additional","affiliation":[{"name":"Internal Medicine Unit, Ostuni Hospital, 72017 Ostuni, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Umberto Vespasiani","family":"Gentilucci","sequence":"additional","affiliation":[{"name":"Clinical Medicine and Hepatology Unit, Fondazione Policlinico Universitario Campus Bio-Medico, 00128 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valeria","family":"Pace Palitti","sequence":"additional","affiliation":[{"name":"Internal Medicine and Hepatology Unit, ASL Pescara, 65124 Pescara, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1239-7012","authenticated-orcid":false,"given":"Carlo","family":"Acierno","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, AOR San Carlo, 85100 Potenza, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clelia","family":"Cosentino","sequence":"additional","affiliation":[{"name":"Department of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Mormone","sequence":"additional","affiliation":[{"name":"Department of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosa","family":"Cotugno","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, IRCCS Casa Sollievo 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Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5098-7785","authenticated-orcid":false,"given":"Giulio","family":"Petronio Petronio","sequence":"additional","affiliation":[{"name":"Department of Medicine and Health Sciences \u201cVincenzo Tiberio\u201d, Universit\u00e0 degli Studi del Molise, 86100 Campobasso, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Villone","sequence":"additional","affiliation":[{"name":"Department of Medicine and Health Sciences \u201cVincenzo Tiberio\u201d, Universit\u00e0 degli Studi del Molise, 86100 Campobasso, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Benanti","sequence":"additional","affiliation":[{"name":"Unit of Infectious Diseases, Department of Clinical and Experimental Medicine, ARNAS Garibaldi Nesima Hospital, University of Catania, 95124 Catania, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Cariti","sequence":"additional","affiliation":[{"name":"Department of Medical Sciences, University of Turin, 10124 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabetta","family":"Falbo","sequence":"additional","affiliation":[{"name":"Travel and Migration Medicine Center, P.O. 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