Treatment with bulevirtide in HIV-infected patients with chronic hepatitis D: ANRS HD EP01 BuleDelta and compassionate cohort.

Cirrhosis Entry inhibitors HBV HBV DNA HDV HDV RNA HIV HIV RNA Hepatitis D Pegylated interferon

Journal

JHEP reports : innovation in hepatology

ISSN: 2589-5559

Titre abrégé: JHEP Rep

Pays: Netherlands

ID NLM: 101761237

Informations de publication

Date de publication:
Aug 2024

Historique:

received: 18 10 2023

revised: 22 02 2024

accepted: 27 02 2024

medline: 24 7 2024

pubmed: 24 7 2024

entrez: 24 7 2024

Statut: epublish

Résumé

In France, bulevirtide (BLV) became available in September 2019 through an early access program to treat patients with HDV. The aim of this analysis was to evaluate the efficacy and safety of BLV in patients with HIV and HDV coinfection. Patients received BLV 2 mg ± pegylated interferon-α (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 a HDV RNA decline >2 log The characteristics of the 38 patients were as follows: 28 male, mean age 47.7 years, and mean baseline HDV RNA viral load 5.7 ± 1.2 log Adults 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 pegIFNɑ showed a strong virological response. Bulevirtide is the only EMA-approved drug for HDV treatment, and we showed that it can be used in adults living with HIV, with an overall good tolerability. Bulevirtide induces a virological response in more than 50% of patients, suggesting that bulevirtide should be considered as a first-line therapy in this specific population. Bulevirtide in combination with pegIFNα could be used in patients without pegIFNα contraindication. No specific drug-drug interaction is reported. Bulevirtide is the only EMA-approved drug for HDV treatment, and we showed that it can be used in adults living with HIV, with an overall good tolerability. Bulevirtide induces a virological response in more than 50% of patients, suggesting that bulevirtide should be considered as a first-line therapy in this specific population. Bulevirtide in combination with pegIFNα could be used in patients without pegIFNα contraindication. No specific drug-drug interaction is reported. Bulevirtide is the only EMA-approved drug for HDV treatment, and we showed that it can be used in adults living with HIV, with an overall good tolerability. Bulevirtide induces a virological response in more than 50% of patients, suggesting that bulevirtide should be considered as a first-line therapy in this specific population. Bulevirtide in combination with pegIFNα could be used in patients without pegIFNα contraindication. No specific drug-drug interaction is reported.

Sections du résumé

Background & Aims UNASSIGNED

Methods UNASSIGNED

Patients received BLV 2 mg ± pegylated interferon-α (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 a HDV RNA decline >2 log

Results UNASSIGNED

The characteristics of the 38 patients were as follows: 28 male, mean age 47.7 years, and mean baseline HDV RNA viral load 5.7 ± 1.2 log

Conclusions UNASSIGNED

Adults 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 pegIFNɑ showed a strong virological response.

Impact and implications UNASSIGNED

Bulevirtide is the only EMA-approved drug for HDV treatment, and we showed that it can be used in adults living with HIV, with an overall good tolerability. Bulevirtide induces a virological response in more than 50% of patients, suggesting that bulevirtide should be considered as a first-line therapy in this specific population. Bulevirtide in combination with pegIFNα could be used in patients without pegIFNα contraindication. No specific drug-drug interaction is reported. Bulevirtide is the only EMA-approved drug for HDV treatment, and we showed that it can be used in adults living with HIV, with an overall good tolerability. Bulevirtide induces a virological response in more than 50% of patients, suggesting that bulevirtide should be considered as a first-line therapy in this specific population. Bulevirtide in combination with pegIFNα could be used in patients without pegIFNα contraindication. No specific drug-drug interaction is reported. Bulevirtide is the only EMA-approved drug for HDV treatment, and we showed that it can be used in adults living with HIV, with an overall good tolerability. Bulevirtide induces a virological response in more than 50% of patients, suggesting that bulevirtide should be considered as a first-line therapy in this specific population. Bulevirtide in combination with pegIFNα could be used in patients without pegIFNα contraindication. No specific drug-drug interaction is reported.

Identifiants

DOI: 10.1016/j.jhepr.2024.101057 PMID: 39045338 PMC: PMC11264178

pubmed: 39045338

doi: 10.1016/j.jhepr.2024.101057

pii: S2589-5559(24)00058-2

pmc: PMC11264178

doi:

Types de publication

Journal Article

Langues

eng

Pagination

101057

Investigateurs

François Raffi (F)

Laurent Alric (L)

Patrick Miailhes (P)

Albert Tran (A)

Christiane Stern (C)

Xavier Causse (X)

Simona Tripon (S)

Ghassan Riachi (G)

Olivier Chazouillères (O)

Armando Abergel (A)

Louis d'Alteroche (L)

Jérôme Gournay (J)

Garance Lagadic (G)

Patrizia Carrieri (P)

Ségolène Brichler (S)

Martin Siguier (M)

Jessica Krause (J)

Juliette Foucher (J)

Souad Ben Ali (S)

Magdalena Meszaros (M)

Anne Varaut (A)

Valérie Canva (V)