A Non-interventional Registry for Patients with Hepatitis B Virus Infection

The European HBV Registry: a Joint Initiative of TherVacB and DZIF

In order to tackle the unmet needs in chronic HBV infection, a consortium of clinical partners has gathered to establish a registry for patients with hepatitis B mono- and co-infections. The partners will build up a European-wide registry to be able to stratify patients for upcoming clinical trials.

Extensive analyses of virus and host-specific parameters are to be carried out from these patients. The knowledge gained thereby should contribute to a better understanding of the HBV control and enable patient stratification with regard to immunomodulatory therapies.

Furthermore, hepatitis B patients are to be identified who are willing to participate in future studies to investigate immunotherapies to cure HBV infections (e.g. therapeutic vaccines).

Inclusion Criteria:

• Hepatitis B Virus Infection

TherVacB sub-cohort:

• confirmed chronic hepatitis B virus infection: HBsAg positive for at least 1 year prior inclusion
• HBeAg status documented for at least 6 months

Exclusion Criteria:

TherVacB sub-cohort:

• age >70 years
• co-infection with HIV, HCV (RNA positive),
• clinically relevant concomitant liver diseases (ALD, NASH, Haemochromatosis, Autoimmune hepatitis, AT1, Wilson's disease, primary biliary cirrhosis etc.)
• significant comorbidities (e.g. malignancies)
• immunosuppressive treatment (> 40 mg Cortisol- equivalent)
• liver cirrhosis (judged clinically or based on ultrasound/transient elastography)
• History of hepatocellular carcinoma