Evidence map›Paper›PMID 39853842›Full record

Trial reportLiver international : official journal of the International Association for the Study of the Liver2025

Phase 2 Randomised Study of Bulevirtide as Monotherapy or Combined With Peg-IFNα-2a as Treatment for Chronic Hepatitis Delta.

Pietro Lampertico, Pavel O Bogomolov, Vladimir Chulanov, Tatiana Stepanova, Viacheslav Morozov, Lena Allweiss, Maura Dandri, Jürgen Burhenne, Antje Blank, Sandra Ciesek and 8 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Liver international : official journal of the International Association for the Study of the Liver, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02888106 (A Multicenter, Open-label, Randomised, Comparative, Parallel-Arm, Phase II Study to Assess Efficacy and Safety of Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

NCT02888106 phase2completednot on this map

A Multicenter, Open-label, Randomised, Comparative, Parallel-Arm, Phase II Study to Assess Efficacy and Safety of Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent

TypeinterventionalSponsorHepatera Ltd.Ran2016 to 2020Enrolled90ConditionsChronic Viral Hepatitis B With Delta-agentArmsMyrcludex B, PEG IFN alfa-2a, Tenofovir
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. From Diagnosis to Durability: A Review of the European Bulevirtide Experience and Practical Learnings for CHD Management.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Review
  2. Article
  3. Review
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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

18 authors.

Pietro LamperticoDivision of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.ORCID 0000-0002-1026-7476
Pavel O BogomolovState Budgetary Institution of Health Care of Moscow Region, Moscow Regional Research Clinical Institute n.a. M.F. Vladimirsky, Moscow, Moscow, Russian Federation.
Vladimir ChulanovNational Medical Research Center of Tuberculosis and Infectious Diseases, Moscow, Russian Federation.
Tatiana StepanovaLimited Liability Company "Clinic of Modern Medicine," Moscow, Moscow, Russian Federation.
Viacheslav MorozovLLC Medical Company Hepatolog, Samara, Russian Federation.
Lena AllweissDepartment of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Maura DandriDepartment of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0002-0073-6689
Jürgen BurhenneDepartment of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany.
Antje BlankDepartment of Clinical Pharmacology and Pharmacoepidemiology, Heidelberg University Hospital, Heidelberg, Germany.
Sandra CiesekInstitute for Medical Virology, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt, Germany.
Carina ElsnerInstitute for Virology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Ulf DittmerInstitute for Virology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Qi AnGilead Sciences Inc., Foster City, California, USA.
Dmitry ManuilovGilead Sciences Inc., Foster City, California, USA.ORCID 0009-0005-3873-096X
Ben L DaGilead Sciences Inc., Foster City, California, USA.
John F FlahertyGilead Sciences Inc., Foster City, California, USA.
Stephan UrbanGerman Center for Infection Research (DZIF), Heidelberg, Germany.
Heiner WedemeyerDepartment of Gastroenterology, Hepatology, Endocrinology, and Infectious Diseases, Hannover Medical School, Hannover, Germany.ORCID 0000-0003-2906-0480

Funding

German Center for Infection Research (DZIF; Braunschweig, Germany)Gilead Sciences Inc. (Foster City, CA, USA)Hepatera (Moscow, Russian Federation)MYR GmbH (Bad Homburg, Germany)
6 · The paper itself

Abstract

BACKGROUND AND

aimBulevirtide (BLV) leads to beneficial virologic and biochemical responses when given alone to treat hepatitis delta virus (HDV) infection, which causes the most severe form of chronic viral hepatitis. We evaluated 48 weeks of BLV monotherapy, BLV + tenofovir disoproxil fumarate (TDF) and BLV + pegylated interferon alfa-2a (Peg-IFNα-2a), with 24-week follow-up.

methodsNinety patients were enrolled into six arms of 15 each (A-F); 60 patients were included in the main randomisation (arms A-D), and 30 patients (arms E-F) were randomised to the extension phase: (A) Peg-IFNα-2a 180 μg once weekly (QW); (B) BLV 2 mg once daily (QD) + Peg-IFNα-2a 180 μg QW; (C) BLV 5 mg QD + Peg-IFNα-2a 180 μg QW; (D) BLV 2 mg QD; (E) BLV 10 mg QD + Peg-IFNα-2a 180 μg QW and (F) BLV 10 mg (5 mg twice daily) + TDF QD. The primary endpoint was undetectable HDV RNA at week (W)72.

resultsAt W72, 53%, 27%, 7%, 7% and 33% of patients achieved undetectable HDV RNA in arms B, C, D, E and F, respectively, versus 0% in arm A. More arm B versus A patients had a > 1 log

conclusionsBLV combined with Peg-IFNα-2a was well tolerated and resulted in high rates of HDV RNA undetectability off-treatment.

trial registrationNCT02888106.

Indexed as

Antiviral AgentsHepatitis D, ChronicInterferon-alphaPeptidesPolyethylene GlycolsAdultDrug Therapy, CombinationFemaleHepatitis Delta VirusHumansMaleMiddle AgedNucleic AcidsPolymersRecombinant ProteinsRNA, ViralAntiviral AgentsInterferon-alphaNucleic Acidspeginterferon alfa-2aPeptidesPolyethylene GlycolsPolymersRecombinant ProteinsREP 2139RNA, ViralTenofovirbulevirtideentry inhibitorHDVHepcludexMyrcludex Bpegylated interferon alfa

Identifiers

PMID39853842
PMCPMC11760647

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Registered trials

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.