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

Victor de Lédinghen (1, 2) , Claire Fougerou-Leurent (3, 4) , Estelle Le Pabic (3, 4) , Stanislas Pol (5, 6, 7) , Dulce Alfaiate (8, 9) , Karine Lacombe (10) , Marie-Noëlle Hilleret (11) , Caroline Lascoux-Combe (12) , Anne Minello (13) , Eric Billaud , Isabelle Rosa (14) , Anne Gervais , Vlad Ratziu (6) , Nathalie Ganne (15) , Georges-Philippe Pageaux (16) , Vincent Leroy , Véronique Loustaud-Ratti (17) , Philippe Mathurin , Julie Chas (18) , Caroline Jezequel (4) , Sophie Métivier , Jérôme Dumortier , Jean-Pierre Arpurt , Tarik Asselah (19) , Bruno Roche , Antonia Le Gruyer , Marc-Antoine Valantin (10) , Caroline Scholtès (20) , Emmanuel Gordien , Christelle Tual , Amel Kortebi , Fatoumata Coulibaly , Eric Rosenthal , Miroslava Subic-Levrero (21) , Dominique Roulot , Fabien Zoulim (21) , 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
Eric Billaud
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Anne Gervais
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Nathalie Ganne
Vincent Leroy
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Philippe Mathurin
Julie Chas
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Sophie Métivier
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Jérôme Dumortier
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Jean-Pierre Arpurt
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Bruno Roche
Antonia Le Gruyer
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Emmanuel Gordien
Christelle Tual
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Amel Kortebi
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Fatoumata Coulibaly
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Eric Rosenthal
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Dominique Roulot
Marc Bourlière
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Emmanuel Gordien
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Fabienne Marcellin
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Fatoumata Coulibaly
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Victor de Lédinghen
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Catherine Gaudy-Graffin
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Jeremie Guedj
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Michelle Sizorn
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Marianne L’hénaff
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Karine Lacombe
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Elise Landry
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Estelle Le Pabic
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Massimo Levrero
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Manal Mecheri
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Ventzislava Petrov-Sanchez
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Alain Renault
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Dominique Roulot
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Caroline Scholtès
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Lawrence Serfaty
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Miroslava Subic-Levrero
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Christelle Tual
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Fabien Zoulim
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François Raffi
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Laurent Alric
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Patrick Miailhes
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Albert Tran
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Christiane Stern
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Xavier Causse
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Simona Tripon
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Ghassan Riachi
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Olivier Chazouillères
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Armando Abergel
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Jérôme Gournay
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Garance Lagadic
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Patrizia Carrieri
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Ségolène Brichler
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Martin Siguier
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Jessica Krause
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Juliette Foucher
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Souad Ben Ali
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Magdalena Meszaros
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Anne Varaut
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Valérie Canva
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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.
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hal-04596035 , version 1 (24-09-2024)

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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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