ANRS HEPDELTA cohort

National cohort of patients co-infected with hepatitis B and Delta viruses

Last updated on 09 October 2024

The essential

This is an observatory of patients infected with HDV, whether treated or not, followed up in French centres, funded and sponsored by ANRS MIE.

Hepatitis D

The natural history of patients infected with HDV is poorly understood. It is generally accepted that viral hepatitis Delta is the most severe form of viral hepatitis. However, these studies go back a long way and are often carried out in specific populations (Asian patients, American patients, etc.). The natural history of VHD patients treated in France is not known.

Patients with hepatitis B-Delta have complex medical histories due to the severity of their liver disease and associated co-morbidities. It is also possible that some patients never develop severe liver disease.

Objectives of the ANRS HEPDELTA cohort

Main objective : to study the natural history of patients infected with HDV according to the different management modalities.

This cohort will make it possible to identify factors associated with worsening liver disease. Many new treatments are or will be available for these patients. They will therefore be able to receive a variety of treatment regimens, ranging from long-term monotherapy to time-limited combined treatment or a succession of several lines of treatment. The adverse effects of these treatments will of course be collected. Factors predictive of response to treatment may also be investigated.

These real-life data will be important in providing information to guide therapeutic adjustments.

Secondary objectives

Assessing the virological response to VHD
Assessing HBV virological response
Assessing hepatic response
Assessing clinical response
Evaluate the tolerability of treatment in patients being treated
Evaluate quality of life, socio-economic situation, behaviours and symptoms experienced, and compliance with treatment where appropriate

In brief

Investigator and co-investigator
Pr Fabien Zoulim and Dr Hélène FONTAINE

Delegated coordinating investigator
Dr Miroslava SUBIC-LEVRERO

Pathologies
Hepatitis B / Hepatitis C / HIV

Status
In progress

Sponsorship
ANRS MIE

Structure/teams
CIC Inserm 1414 – Rennes University Hospital, Aix Marseille University, Inserm U1259 at Tours University Hospital, Inserm UMR1137 in Paris, Avicenne Hospital in Bobigny, France and University Hospital Freiburg, Germany.

It should be noted that the main objective of this cohort, initially called “Buledelta”, was to evaluate the efficacy of bulevirtide treatment as standard care in patients co-infected with HBV/HDV. Assessment of efficacy was based on therapeutic response, defined as a reduction in Delta RNA of at least 2 log10.

The ANRS HD EP01 BuleDelta cohort was evaluated by the ANRS MIE Cohort Evaluation Committee on 25 November 2021. This committee issued recommendations concerning the cohort’s name and scientific scope. In accordance with the Scientific Advisory Board of the study, the Sponsor has approved the change of name of the cohort, the modification of the objectives the evaluation criteria and the selection criteria.

Which patients are included in the ANRS HEPDELTA cohort?

Adult patient (≥ 18 years),
Infected with the hepatitis Delta virus (positive serology)
Having given their free, informed and written consent, co-signed by the investigator (no later than the day of inclusion and before any examination carried out as part of the research) (article L1122-1-1 of the Public Health Code)
Member or beneficiary of a social security scheme (Article L1121-11 of the French Public Health Code) or of State Medical Aid (AME)

More information

Last publications

Find out more about these publications in our interviews with Dr Claire Fougerou-Leurent and Dr Jérémie Guedj.

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

de Lédinghen V, Fougerou-Leurent C, Le Pabic E, Pol S, Alfaiate D, Lacombe K, Hilleret MN, Lascoux-Combe C, Minello A, Billaud E, Rosa I, Gervais A, Ratziu V, Ganne N, Pageaux GP, Leroy V, Loustaud-Ratti V, Mathurin P, Chas J, Jezequel C, Métivier S, Dumortier J, Arpurt JP, Asselah T, Roche B, Le Gruyer A, Valantin MA, Scholtès C, Gordien E, Tual C, Kortebi A, Coulibaly F, Rosenthal E, Subic-Levrero M, Roulot D, Zoulim F; ANRS HD EP01 BuleDelta study group. JHEP Rep. 2024 Mar 26;6(8):101057. https://doi.org/10.1016/j.jhepr.2024.101057.

Effect of Peg-IFN on the viral kinetics of patients with HDV infection treated with bulevirtide

Selma El Messaoudi, Ségolène Brichler, Claire Fougerou-Leurent, Emmanuel Gordien, Athenaïs Gerber, Amal Kortebi, Garance Lagadic, Miroslava Subic-Levrero, Sophie Metivier, Stanislas Pol, Anne Minello, Vlad Ratziu, Vincent Leroy, Philippe Mathurin, Laurent Alric, Fatoumata Coulibaly, Jean-Michel Pawlotsky, Fabien Zoulim, Victor de Lédinghen, Jérémie Guedj. JHEP Rep. 2024 March 22;6(8):101070. DOI:https://doi.org/10.1016/j.jhepr.2024.101070

Traitement par bulevirtide des patients co-infectés par le VIH-VHB-VHD. Analyse des données en vie réelle.

V. de Lédinghen, C. Fougerou-Leurent, M. Subic, C. Scholtès, E. Gordien, S. Pol, K. Lacombe, D. Alfaiate, F. Coulibaly, F. Zoulim. Médecine et Maladies Infectieuses Formation, 2023 ;2 (Issue 2, Supplement) : S85-S86. https://doi.org/10.1016/j.mmifmc.2023.03.206.