Evidence map›Paper›PMID 40007006›Full record

Observational studyViruses2025

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

Luca Rinaldi, Mauro Viganò, Alessia Ciancio, Alfredo Caturano, Vincenzo Messina, Grazia Anna Niro, Nicolina Capoluongo, Alessandro Loglio, Letizia Marinaro, Aldo Marrone and 24 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Viruses, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors.

Luca RinaldiDepartment of Medicine and Health Sciences "Vincenzo Tiberio", Università degli Studi del Molise, 86100 Campobasso, Italy.
Mauro ViganòGastroenterology, Hepatology and Transplantation Division, ASST Papa Giovanni XXIII, 24127 Bergamo, Italy.ORCID 0000-0003-0769-1767
Alessia CiancioDepartment of Medical Sciences, University of Turin, 10124 Turin, Italy.ORCID 0000-0003-4188-0609
Alfredo CaturanoDepartment of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, Italy.ORCID 0000-0001-7761-7533
Vincenzo MessinaInfectious Diseases Unit, Sant'Anna e San Sebastiano Hospital, 81100 Caserta, Italy.
Grazia Anna NiroDepartment of Gastroenterology, IRCCS Casa Sollievo della Sofferenza, 71013 San Giovanni Rotondo, Italy.
Nicolina CapoluongoDepartment of Emergency Infectious Diseases and Infectious Diseases, Ospedali dei Colli, P.O.D. Cotugno, 80131 Naples, Italy.
Alessandro LoglioGastroenterology, Hepatology and Transplantation Division, ASST Papa Giovanni XXIII, 24127 Bergamo, Italy.ORCID 0000-0001-8022-8803
Letizia MarinaroDepartment of Medical Sciences, University of Turin, 10124 Turin, Italy.ORCID 0000-0002-0896-1469
Aldo MarroneDepartment of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, Italy.
Ernesto ClaarDepartment of Medicine, Ospedale Evangelico Villa Betania, 80147 Naples, Italy.
Maurizio RusselloLiver Unit, ARNAS Garibaldi Nesima, 95124 Catania, Italy.
Emanuela CiracìInternal Medicine Unit, Ostuni Hospital, 72017 Ostuni, Italy.
Umberto Vespasiani GentilucciClinical Medicine and Hepatology Unit, Fondazione Policlinico Universitario Campus Bio-Medico, 00128 Rome, Italy.
Valeria Pace PalittiInternal Medicine and Hepatology Unit, ASL Pescara, 65124 Pescara, Italy.
Carlo AciernoDepartment of Emergency Medicine, AOR San Carlo, 85100 Potenza, Italy.ORCID 0000-0002-1239-7012
Clelia CosentinoDepartment of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, Italy.
Andrea MormoneDepartment of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, Italy.
Rosa CotugnoDepartment of Gastroenterology, IRCCS Casa Sollievo della Sofferenza, 71013 San Giovanni Rotondo, Italy.
Francesca TerraccianiClinical Medicine and Hepatology Unit, Fondazione Policlinico Universitario Campus Bio-Medico, 00128 Rome, Italy.
Paolo GalloClinical Medicine and Hepatology Unit, Fondazione Policlinico Universitario Campus Bio-Medico, 00128 Rome, Italy.ORCID 0000-0001-8292-1134
Maria Rita CannavòLiver Unit, ARNAS Garibaldi Nesima, 95124 Catania, Italy.
Valerio RosatoDepartment of Medicine, Ospedale Evangelico Villa Betania, 80147 Naples, Italy.ORCID 0000-0002-3584-2414
Ferdinando Carlo SassoDepartment of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, Italy.ORCID 0000-0002-9142-7848
Chiara PetruccielloDepartment of Medicine and Health Sciences "Vincenzo Tiberio", Università degli Studi del Molise, 86100 Campobasso, Italy.
Giulio Petronio PetronioDepartment of Medicine and Health Sciences "Vincenzo Tiberio", Università degli Studi del Molise, 86100 Campobasso, Italy.ORCID 0000-0002-5098-7785
Giovanni VilloneDepartment of Medicine and Health Sciences "Vincenzo Tiberio", Università degli Studi del Molise, 86100 Campobasso, Italy.
Francesco BenantiUnit of Infectious Diseases, Department of Clinical and Experimental Medicine, ARNAS Garibaldi Nesima Hospital, University of Catania, 95124 Catania, Italy.
Giuseppe CaritiDepartment of Medical Sciences, University of Turin, 10124 Turin, Italy.
Elisabetta FalboTravel and Migration Medicine Center, P.O. Lamezia Terme Hospital, 88046 Calabria, Italy.
Marco DistefanoHepatology Unit, ASP 8, 96100 Siracusa, Italy.ORCID 0000-0003-2616-4276
Rodolfo SaccoGastroenterology and Digestive Endoscopy Unit, Foggia University Hospital, 71122 Foggia, Italy.ORCID 0000-0002-9887-7315
Alessandro PerrellaDepartment of Emergency Infectious Diseases and Infectious Diseases, Ospedali dei Colli, P.O.D. Cotugno, 80131 Naples, Italy.ORCID 0000-0003-2812-8500
Antonio IzziDepartment of Emergency Infectious Diseases and Infectious Diseases, Ospedali dei Colli, P.O.D. Cotugno, 80131 Naples, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHepatitis 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.

methodsThis 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.

resultsThe virological response was achieved in 54.6% of patients (

conclusionsBulevirtide 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.

Indexed as

Antiviral AgentsHepatitis D, ChronicHepatitis Delta VirusPeptidesAdultAgedFemaleHumansMaleMiddle AgedNucleic AcidsPilot ProjectsPolymersProspective StudiesRNA, ViralTreatment OutcomeAntiviral AgentsNucleic AcidsPeptidesPolymersREP 2139RNA, Viralantiviral treatment outcomesbulevirtide therapyhepatitis delta virusliver disease managementsafety and efficacy

Identifiers

PMID40007006
PMCPMC11860205

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.