Prospective Cohort of HIV/HBV-coinfected Patients in Europe

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-10-02

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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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:

1. 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
2. evaluate predictors of HBsAg loss and its correlation with Hepatitis B core-related antigen (HBcrAg) and pre-genomic RNA (pgRNA) levels
3. explore risk factors for low-level HBV replication after 2 years of therapy
4. describe changes in liver fibrosis stage and rates of transaminase normalization over time and according to HBV therapy outcome
5. assess rates and reasons of treatment interruptions or changes.

Conditions

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HIV Infections Hepatitis B Coinfection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles Wandeler, MD MSc

Role: STUDY_CHAIR

Insel Gruppe AG, University Hospital Bern

Other Identifiers

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CO-SW-985-5602

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Euro-B

Identifier Type: -

Identifier Source: org_study_id