HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection

Summary

The aim of this project is to set up a cross-sectional cohort study (France, Germany, The Netherlands, Poland, Spain, Switzerland, Italy, United Kingdom and Portugal) to assess the implementation of EACS guidelines for HDV-testing among PLWH with positive HbsAg and thereby evaluate the prevalence of HDV infection among HIV/HBV-coinfected in 2023, as well as corresponding risk factors. In addition to the testing itself, this study will also set up a cohort and databasee for future HDV studies among PLWH, including clinical, virological und laboratory parameters.

1. Analyze the rate of HDV-testing and evaluate the prevalence of HDV-infection by testing.

1. Evaluation of former screening of HDV by assessing existing data at study sites.
2. Determination of the HDV prevalence in European PLWH and HBV coinfection.
2. Setting up a database of all PLWH with HBV/HDV coinfection

1. Analysis of transmission risk factors for HDV coinfection
2. Asses the rate of HDV positive patients with ongoing HDV replication.
3. Define the liver disease state by APRI score, fibroscan, ultrasound and routine laboratory test results.

Conditions

• Hepatitis D

Interventions

OTHER

HDV screening

1\. Analyze the rate of HDV-testing and evaluate the prevalence of HDV-infection by testing.

Sponsors & Collaborators

• Swiss HIV Cohort Study

  collaborator NETWORK

• ICONA Cohort

  collaborator UNKNOWN

• Amsterdam UMC

  collaborator OTHER

• Royal Free Hospital NHS Foundation Trust

  collaborator OTHER

• King's College London

  collaborator OTHER

• University Hospital of Cologne

  collaborator OTHER

• Goethe University

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  collaborator OTHER

• University Hospital, Essen

  collaborator OTHER

• ICH Hamburg

  collaborator UNKNOWN

• Praxiszentrum Hohenstaufenring Köln

  collaborator UNKNOWN

• Sorbonne University

  collaborator OTHER

• Henri Mondor University Hospital

  collaborator OTHER

• Hospital Universitario Infanta Leonor

  collaborator OTHER

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• GEPCOI (Portuguese Group of Coinfection)

  collaborator UNKNOWN

• University Hospital, Bonn

  lead OTHER

Principal Investigators

• Jürgen Rockstroh, MD · University Hospital, Bonn

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2024-12-31

Completion

2025-06-30

Countries

• Germany

Study Locations