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| ID | Type | Description | Link |
|---|---|---|---|
| CO-SW-985-5602 | Other Grant/Funding Number | Gilead Sciences |
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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.
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:
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| Measure | Description | Time Frame |
|---|---|---|
| HBV suppression | Proportion of participants achieving undetectable HBV DNA | 2 years of TDF/TAF-containing treatment and last available timepoint |
| HBsAg loss | Proportion of participants with a negative HBsAg measurement | 2 years of TDF/TAF-containing treatment and last available timepoint |
| HBeAg loss | Proportion of participants with a negative HBeAg measurement | 2 years of TDF/TAF-containing treatment and last available timepoint |
| Transaminase normalization | Proportion of participants with transaminase normalization | 2 years of TDF/TAF-containing treatment and last available timepoint |
| Liver fibrosis change | Proportion of participants with a change in liver fibrosis stage | 2 years of TDF/TAF-containing treatment and last available timepoint |
| Treatment interruption or change | Assessments of rates and reasons for treatment interruptions or changes | 2 years of TDF/TAF-containing treatment and last available timepoint |
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Inclusion Criteria:
Exclusion Criteria:
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HIV/HBV-coinfected individuals treated with tenofovir from Europe
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Wandeler, MD MSc | Insel Gruppe AG, University Hospital Bern | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41551412 | Derived | 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 determinants of HBsAg loss in persons with HIV in Europe. JHEP Rep. 2025 Nov 7;8(2):101671. doi: 10.1016/j.jhepr.2025.101671. eCollection 2026 Feb. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006509 | Hepatitis B |
| D060085 | Coinfection |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Plasma/serum
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |