Observatory of Efficacy and Safety of Bulevirtide in Patients With Chronic HBV/HDV Co-infection (BuleDelta)

ANRS, Emerging Infectious Diseases

Status: Enrolling

Conditions: Hepatitis B, Chronic; Hepatitis D, Chronic

Study type: Observational

Funder types: Other

Identifiers

NCT04166266

ANRS HD EP01-BULEDELTA

Details and patient eligibility

About

This is a prospective, multicentric, non comparative study, with a retrospective data collection aiming at evaluating the efficacy and safety of bulevirtide in patients with chronic HBV/HDV co-infection with severe fibrosis injuries, or moderate fibrosis injuries associated with persistent increase of ALT.

Full description

Chronic hepatitis delta represents the most severe form of chronic viral hepatitis.The current treatment of hepatitis delta virus (HDV) infection consists in the use of interferon and is largely unsatisfactory. Bulevirtide is an entry inhibitor which has demonstrated significant virologic and biochemical activity in patients with HDV infection in clinical trials.

The ANRS HDEP01 BuleDelta study is an observational cohort, embedded in the french bulevirtide ATU program.

After their inclusion, patients will be followed according to the ATU protocol during treatment within the cohort ATU and according to the usual recommendations during treatment within the nominative ATU (if needed) and after the end of bulevirtide treatment. The patients included will be followed during 48 weeks after the end of their treatment.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years,

• Presenting a chronic HDV infection,

• With an indication for or already treated by bulevirtide within the French compassionate program (ATU)

  1. with compensated cirrhosis or severe liver fibrosis (Metavir fibrosis score 3 or 4 according to liver biopsy or Fibroscan®) or
  2. moderate liver fibrosis (Metavir fibrosis score 2 according to liver biopsy or Fibroscan®) associated with persistent increase of the ALT level (ALT>2*normal for more than 6 months).

• Who gave his written informed consent before any intervention and the day of inclusion at the latest,

• Affiliated to Health Insurance or to the "Aide Médicale d'Etat" (request for exemption pending).

Exclusion criteria

• Contra-indications to treatment with bulevirtide : hypersensibility to the substance or to one of its excipients ,
• Patient participating in another biomedical research with an exclusion period ongoing at inclusion,
• Vulnerable patient (minor, pregnant or breastfeeding woman, adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty).
• Patients with predictable difficulties of follow-up according to the investigator.