Cohort ANRS HD EP 01 HEPDELTA

HEPDELTA cohort

This is a national cohort of patients infected with HDV, whether treated or not, followed up in French centres. 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. 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

Initially named ‘Buledelta’, the aim of this cohort was to evaluate the efficacy of bulevirtide in HBV/HDV co-infected patients, with a reduction in Delta RNA of at least 2 log10 as the primary endpoint. In November 2021, the ANRS MIE Cohort Evaluation Committee recommended a name change and a modification of the cohort’s objectives and scientific scope. In agreement with the Scientific Advisory Board of the study, the Sponsor validated the change of name of the cohort, and the modification of the objectives, judgment criteria and selection criteria.

Objectives of the HEPDELTA cohort

Main objective

• The main objective is to study the natural or treated history of patients infected with HDV according to different management modalities.

Secondary objectives

• Assess HDV virological response
• Assess HBV virological response
• Assess hepatic response (biochemical and fibrosis)
• Assess clinical response (occurrence of hepatic events, mortality)
• Assess treatment safety (in treated patients)
• Assess quality of life and patient’s reported outcomes.

Ancillary and exploratory objectives

• To assess the immunological response to bulevirtide treatment (immunological sub-study)
• To evaluate the kinetics of the editing rate under bulevirtide (virological sub-study)
• To analyse the experiences, needs and barriers during treatment in immigrant patients treated with bulevirtide (qualitative sub-study)
• To analyse viral dynamics under bulevirtide treatment and the implications for the optimisation of anti-HDV treatments (viral kinetics sub-study)
• To analyse the anti-preS1 antibodies induced by bulevirtide treatment in patients with chronic hepatitis Delta (AntiPreS1 sub-study).