Prospective Cohort of HIV/HBV-coinfected Patients in Europe
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HIV Infections, Hepatitis B, Coinfection. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Understanding Treatment Outcomes of HIV/HBV Coinfection: A Prospective Cohort of HIV/HBV-coinfected Patients in Europe
Overview
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
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.
Primary outcome measures
- HBV suppression [Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint]
- HBsAg loss [Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint]
- HBeAg loss [Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint]
- Transaminase normalization [Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint]
- Liver fibrosis change [Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint]
- Treatment interruption or change [Time frame: 2 years of TDF/TAF-containing treatment and last available timepoint]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Begre L, Boyd A, Plissonnier ML, Testoni B, Beguelin C, Suter-Riniker F, Scholtes C, Rockstroh JK, Lacombe K, Peters L, Heil M, Levrero M, Rauch A, Zoulim F, Wandeler G; Swiss HIV Cohort Study, EuroSIDA and French HIV/HBV and Biliver cohorts; Members of the EuroSIDA Study Group; Members of the French HIV/HBV and Biliver cohorts. Circulating HBV RNA and hepatitis B core-related antigen as determina PMID 41551412
Identifiers
NCT: NCT04984772 · Euro-B · CO-SW-985-5602