Treatment With Bulevirtide in HIV Infected patients With chronic Hepatitis Delta. ANRS HD EP01 BULEDELTA & Compassionate Cohort

Victor de Lédinghen; Claire Fougerou-Leurent; Estelle Le Pabic; Stanislas Pol; Dulce Alfaiate; Karine Lacombe; Marie-Noëlle Hilleret; Caroline Lascoux-Combe; Anne Minello; Eric Billaud; Isabelle Rosa; Anne Gervais; Vlad Ratziu; Nathalie Ganne; Georges-Philippe Pageaux; Vincent Leroy; Véronique Loustaud-Ratti; Philippe Mathurin; Julie Chas; Caroline Jezequel; Sophie Métivier; Jérôme Dumortier; Jean-Pierre Arpurt; Tarik Asselah; Bruno Roche; Antonia Le Gruyer; Marc-Antoine Valantin; Caroline Scholtès; Emmanuel Gordien; Christelle Tual; Amel Kortebi; Fatoumata Coulibaly; Eric Rosenthal; Miroslava Subic-Levrero; Dominique Roulot; Fabien Zoulim; Marc Bourlière; Emmanuel Gordien; Fabienne Marcellin; Fatoumata Coulibaly; Victor de Lédinghen; Catherine Gaudy-Graffin; Jeremie Guedj; Michelle Sizorn; Marianne L’hénaff; Karine Lacombe; Elise Landry; Estelle Le Pabic; Massimo Levrero; Manal Mecheri; Ventzislava Petrov-Sanchez; Alain Renault; Dominique Roulot; Caroline Scholtès; Lawrence Serfaty; Miroslava Subic-Levrero; Christelle Tual; Fabien Zoulim; François Raffi; Laurent Alric; Patrick Miailhes; Albert Tran; Christiane Stern; Xavier Causse; Simona Tripon; Ghassan Riachi; Olivier Chazouillères; Armando Abergel; Jérôme Gournay; Garance Lagadic; Patrizia Carrieri; Ségolène Brichler; Martin Siguier; Jessica Krause; Juliette Foucher; Souad Ben Ali; Magdalena Meszaros; Anne Varaut; Valérie Canva

doi:10.1016/j.jhepr.2024.101057

Journal Articles JHEP Reports Innovation in Hepatology Year : 2024

Treatment With Bulevirtide in HIV Infected patients With chronic Hepatitis Delta. ANRS HD EP01 BULEDELTA & Compassionate Cohort

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Victor de Lédinghen

Function : Correspondent author
PersonId : 1387823

Connectez-vous pour contacter l'auteur

Bordeaux population health

BoRdeaux Institute in onCology

Claire Fougerou-Leurent

Function : Author
PersonId : 1369546
ORCID : 0000-0003-2736-6769

Centre d'Investigation Clinique [Rennes]

Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]

Estelle Le Pabic

Function : Author
PersonId : 1041362
ORCID : 0000-0001-9796-1294

Centre d'Investigation Clinique [Rennes]

Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]

Stanislas Pol

Function : Author

Hôpital Cochin [AP-HP]

Assistance publique - Hôpitaux de Paris (AP-HP)

Institut Cochin

Dulce Alfaiate

Function : Author
PersonId : 1387824
ORCID : 0000-0002-6160-5578

Université de Genève = University of Geneva

Hôpital de la Croix-Rousse [CHU - HCL]

Karine Lacombe

Function : Author
PersonId : 761537
ORCID : 0000-0001-8772-9029
IdRef : 111113245

Institut Pierre Louis d'Epidémiologie et de Santé Publique

Marie-Noëlle Hilleret

Function : Author

Centre Hospitalier Universitaire [CHU Grenoble]

Caroline Lascoux-Combe

Function : Author

Hopital Saint-Louis [AP-HP]

Anne Minello

Function : Author
PersonId : 1369547
ORCID : 0000-0002-5014-5238

Lipides - Nutrition - Cancer [Dijon - U1231]

Eric Billaud

Function : Author

Isabelle Rosa

Function : Author
PersonId : 1387825
ORCID : 0000-0001-6879-3148

Centre Hospitalier Intercommunal de Créteil

Anne Gervais

Function : Author

Vlad Ratziu

Function : Author

Assistance publique - Hôpitaux de Paris (AP-HP)

Nathalie Ganne

Function : Author
PersonId : 781655
ORCID : 0000-0002-7351-5027
IdRef : 083611886

Hôpital Avicenne [AP-HP]

Georges-Philippe Pageaux

Function : Author
PersonId : 1225386
ORCID : 0000-0001-5269-8373

Hôpital Saint Eloi [CHU Montpellier]

Vincent Leroy

Function : Author

Véronique Loustaud-Ratti

Function : Author

Ciblage individuel et prévention des risques de traitements immunosupresseurs et de la transplantation

Philippe Mathurin

Function : Author
PersonId : 903127
ORCID : 0000-0003-3447-2025

Julie Chas

Function : Author

CHU Tenon [AP-HP]

Caroline Jezequel

Function : Author

Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]

Sophie Métivier

Function : Author

Jérôme Dumortier

Function : Author

Jean-Pierre Arpurt

Function : Author

Tarik Asselah

Function : Author

Centre de recherche sur l'Inflammation

Bruno Roche

Function : Author
PersonId : 1269253
ORCID : 0000-0001-6666-1862

Antonia Le Gruyer

Function : Author

Marc-Antoine Valantin

Function : Author

Institut Pierre Louis d'Epidémiologie et de Santé Publique

Caroline Scholtès

Function : Author

Hospices Civils de Lyon

Emmanuel Gordien

Function : Author
PersonId : 1052183
ORCID : 0000-0003-2664-9417

Christelle Tual

Function : Author

Amel Kortebi

Function : Author

Fatoumata Coulibaly

Function : Author

Eric Rosenthal

Function : Author

Miroslava Subic-Levrero

Function : Author

Centre de Recherche en Cancérologie de Lyon

Dominique Roulot

Function : Author
PersonId : 1197474
ORCID : 0000-0003-0926-3563

Fabien Zoulim

Function : Author

Centre de Recherche en Cancérologie de Lyon

Marc Bourlière

Function : Author

Emmanuel Gordien

Function : Author

Fabienne Marcellin

Function : Author

Fatoumata Coulibaly

Function : Author

Victor de Lédinghen

Function : Author

Catherine Gaudy-Graffin

Function : Author

Jeremie Guedj

Function : Author

Michelle Sizorn

Function : Author

Marianne L’hénaff

Function : Author

Karine Lacombe

Function : Author

Elise Landry

Function : Author

Estelle Le Pabic

Function : Author

Massimo Levrero

Function : Author

Manal Mecheri

Function : Author

Ventzislava Petrov-Sanchez

Function : Author

Alain Renault

Function : Author

Dominique Roulot

Function : Author

Caroline Scholtès

Function : Author

Lawrence Serfaty

Function : Author

Miroslava Subic-Levrero

Function : Author

Christelle Tual

Function : Author

Fabien Zoulim

Function : Author

François Raffi

Function : Author

Laurent Alric

Function : Author

Patrick Miailhes

Function : Author

Albert Tran

Function : Author

Christiane Stern

Function : Author

Xavier Causse

Function : Author

Simona Tripon

Function : Author

Ghassan Riachi

Function : Author

Olivier Chazouillères

Function : Author

Armando Abergel

Function : Author

Jérôme Gournay

Function : Author

Garance Lagadic

Function : Author

Patrizia Carrieri

Function : Author

Ségolène Brichler

Function : Author

Martin Siguier

Function : Author

Jessica Krause

Function : Author

Juliette Foucher

Function : Author

Souad Ben Ali

Function : Author

Magdalena Meszaros

Function : Author

Anne Varaut

Function : Author

Valérie Canva

Function : Author

Abstract

Background and AimsIn France, Bulevirtide (BLV) was available in September 2019 through an early access program to treat patients with hepatitis Delta virus (HDV). The aim of this analysis was to evaluate the efficacy and safety of BLV in HIV patients with HDV coinfection.Patients and methodsPatients received BLV 2 mg +/- pegylated interferon (pegIFNα) according to the physician’s decision. The primary endpoint (per-protocol analysis) was the virological response rate at week 48, defined as the proportion of patients with undetectable serum HDV-RNA or HDV-RNA decline > 2 log10 IU/mL from baseline.ResultsCharacteristics of the 38 patients were as follow: 28 male, mean age 47.7 years, mean baseline HDV-RNA viral load 5.7 ± 1.2 log10 IU/ml. Median HIV viral load and mean CD4 count were 32 (30 - 65) cp/ml and 566 ± 307/mm3, respectively. Eight patients stopped treatment before week 48. At W48, 10 of 19 patients (52.6%) in the 2 mg BLV group, and 5 of 7 patients (71.4%) in the 2 mg BLV + pegIFNα group had reached virological response (no HDV-RNA available in 4 patients). At W48, 7/19 patients in the 2 mg BLV group, and 3/6 patients in the 2 mg BLV + pegIFNα group had combined response (virological response and normal ALT level).ConclusionAdults living with HIV coinfected with HDV can be treated by BLV with a virological response in more than 50% of patients. The combination of BLV and pegIFNα showed a strong virological response.

Keywords

Cirrhosis HDV HBV pegylated interferon hepatitis D HDV-RNA HIV HIV RNA entry inhibitors HBV DNA

Domains

Life Sciences [q-bio]

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PIIS2589555924000582.pdf (560.8 Ko)

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https://univ-rennes.hal.science/hal-04596035

Submitted on : Tuesday, September 24, 2024-1:13:07 PM

Last modification on : Thursday, November 7, 2024-2:21:34 PM

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hal-04596035 , version 1 (24-09-2024)

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HAL Id : hal-04596035 , version 1
DOI : 10.1016/j.jhepr.2024.101057

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Victor de Lédinghen, Claire Fougerou-Leurent, Estelle Le Pabic, Stanislas Pol, Dulce Alfaiate, et al.. Treatment With Bulevirtide in HIV Infected patients With chronic Hepatitis Delta. ANRS HD EP01 BULEDELTA & Compassionate Cohort. JHEP Reports Innovation in Hepatology, 2024, pp.101057. ⟨10.1016/j.jhepr.2024.101057⟩. ⟨hal-04596035⟩

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Treatment With Bulevirtide in HIV Infected patients With chronic Hepatitis Delta. ANRS HD EP01 BULEDELTA & Compassionate Cohort

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