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Enrolling by Invitation

NCT Number: NCT04984772

Prospective Cohort of HIV/HBV-coinfected Patients in Europe

The overall aim of the project is to establish an international multi-cohort research platform of HIV/HBV-coinfected individuals treated with tenofovir to improve our understanding of the determinants of treatment outcomes.

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Key information

Conditions

HIV Infections Blood-Borne Infections Coinfection Communicable Diseases DNA Virus Infections Digestive System Diseases Genital Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Hepatitis B virus (HBV) infection is a major cause of morbidity and mortality among human immunodeficiency virus (HIV)-infected individuals and the progression of liver disease is accelerated in this population compared to HBV-monoinfected individuals. Tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) as part of antiretroviral therapy (ART) suppresses HBV viral load in most patients. However, risk factors of suboptimal virological response to TDF/TAF and predictors of hepatitis B surface antigen (HBsAg) loss remain unclear. While novel drugs for HBV therapy are being developed, a more thorough understanding of the factors associated with optimal outcomes is urgent. Euro-B considers all HIV/HBV-coinfected participants from EuroSIDA, the Swiss HIV cohort study and French, Spanish and German HIV-HBV cohorts treated with TDF/TAF for inclusion.

The overall aim of the project is to establish an international prospective multi-cohort research platform of HIV/HBV-coinfected individuals to improve our understanding of the determinants of treatment outcomes, including functional cure of HBV infection. Specifically, we aim to:

  • evaluate HBV virological suppression, hepatitis B e antigen (HBeAg) and HBsAg loss as well as the course of quantitative HBsAg (qHBsAg) levels during TDF/TAF-containing antiretroviral therapy
  • evaluate predictors of HBsAg loss and its correlation with Hepatitis B core-related antigen (HBcrAg) and pre-genomic RNA (pgRNA) levels
  • explore risk factors for low-level HBV replication after 2 years of therapy
  • describe changes in liver fibrosis stage and rates of transaminase normalization over time and according to HBV therapy outcome
  • assess rates and reasons of treatment interruptions or changes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Study participant from contributing cohort
  • 2 positive HBsAg tests more than 6 months apart
  • At least 2 data points (baseline and 2 years after TDF/TAF start either as available data or stored sample

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. HBV suppression

    Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint

    Proportion of participants achieving undetectable HBV DNA

  2. HBsAg loss

    Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint

    Proportion of participants with a negative HBsAg measurement

  3. HBeAg loss

    Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint

    Proportion of participants with a negative HBeAg measurement

  4. Transaminase normalization

    Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint

    Proportion of participants with transaminase normalization

  5. Liver fibrosis change

    Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint

    Proportion of participants with a change in liver fibrosis stage

  6. Treatment interruption or change

    Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint

    Assessments of rates and reasons for treatment interruptions or changes

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Understanding Treatment Outcomes of HIV/HBV Coinfection: A Prospective Cohort of HIV/HBV-coinfected Patients in Europe

Acronym: Euro-B

Important dates

Study start
2001
Primary completion
2030
Study completion
2030
First posted
Aug 2, 2021
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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