Hepatitis D, Chronic, Hepatitis B, Chronic
Conditions
Keywords
safety, efficacy, evolution, treatment
Brief summary
This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from patients with HBV/HDV co-infection.
Detailed description
This is an observatory for patients co-infected with hepatitis B and Delta viruses. Patients will be monitored according to the usual recommendations, depending on their status: * Patients who have never received specific treatment for hepatitis Delta (untreated or receiving treatment with peginterferon alpha 2a alone) will be monitored according to current recommendations, once every 6 months; * Patients treated or having been treated with a specific hepatitis Delta treatment will be monitored according to the compassionate access protocol or according to the recommendations of the AMM during treatment and according to routine follow-up after the end of treatment. Participation in research entails the following additional procedures for patients, for each line of treatment, where applicable: * Samples for the biobank, * Self-administered questionnaires. In addition, as sub-studies are planned on sub-groups of patients, these sub-studies may involve additional constraints/interventions
Interventions
Blood sampling for the biobank and, in addition, as sub-studies are planned on sub-groups of patients, additional blood samples are planned for the patients in these sub-studies.
Sponsors
ANRS, Emerging Infectious Diseases
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years, * Presenting a chronic HDV infection (positive serology), * Who gave his written informed consent before any intervention and the day of inclusion at the latest, * Affiliated to Health Insurance or to the Aide Médicale d'Etat (request for exemption pending).
Exclusion criteria
* Patient participating in another biomedical research with an exclusion period ongoing at inclusion, * Vulnerable patient (minor, adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty). * Patients with predictable difficulties of follow-up according to the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To study the natural or treated history of patients infected with HDV according to different management modalities. | At the end of the follow-up, december 2027 | This is a cohort in which many events will be studied. As the objectives are multiple, no primary endpoint has been defined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of observance measured with specific questionnaire | weeks 24, 48, end of treatment and 48 weeks after the end of treatment | — |
| Alcohol consumption (AUDIT-c), tobacco and cannabis use | weeks 24, 48, end of treatment and 48 weeks after the end of treatment | — |
| Socio-economic situation measured with specific questionnaire | weeks 24, 48, end of treatment and 48 weeks after the end of treatment | — |
| Quality of life level measured with short-form 12 (SF12) questionnaire | At weeks 24, 48, end of treatment and 48 weeks after the end of treatment | — |
| Rate of patients achieving HBV DNA indetectability | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
| Rate of early discontinuation of treatment due to an adverse event | At weeks 12, 24, 48, end of treatment | — |
| HDV RNA level | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
| HDV RNA variation rate | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
| Breakthrough rate | At weeks 8, 12 and through the end of treatment (average 3 years) | — |
| Rate of sustained virological response | At weeks 12, 24, 36 and 48 and through the end of treatment (average 3 years) | HDV RNA undetectability |
| Rate of partial virological response | At weeks 4, 8, 12 and through the end of treatment (average 3 years) | reduction in Delta RNA of at least 2 log10 compared with the basal value, without undetectability |
| Rate of patients achieving HBs seroconversion | At weeks 12, 24, 48,through the end of treatment (average 3 years), and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
| Virological response delay | At weeks 8, 12 and through the end of treatment (average 3 years) | — |
| Number of different HDV resistance variants | Through treatment period, average 3 years | — |
| Number of patients with at least one resistance variant | Through treatment period, average 3 years | — |
| Number of patient's reported outcomes measured with specific questionnaire | weeks 24, 48, end of treatment and 48 weeks after the end of treatment | — |
| Rate of adverse event | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
| Death rate | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
| Liver transplantation rate | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
| Number and characterization of associated treatment with analogs and/or interferon | At weeks 4, 8, 12 and through the end of treatment (average 3 years | — |
| Rate of patients presenting an evolution towards hepatocellular carcinoma | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
| Rate of patients presenting an evolution towards cirrhosis | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | in non-cirrhotic patients |
| Rate of patients presenting a decompensated cirrhosis | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | in non-cirrhotic patients |
| Change in HBs Ag from baseline | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
| Rate of biochemical response | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | Biochemical response is defined as ALT and aspartate aminotransferase (AST) normalization |
| Rate of patients achieving hepatitis B e (HBe) Ag negativation in patient initially HBeAg- positive | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
| Rate of patients with appearance of anti-HBe Ab | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
| Rate of patients achieving HBe seroconversion | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
| Rate of spontaneous virological recovery | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | Prolonged HDV RNA undetectability |
| Rate of patients achieving HBs Ag negativation | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
| Rate of patients with appearance of anti-HBs Ab | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
| Fibrosis level | At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027) | — |
Countries
France
Contacts
Primary ContactCOULIBALY Fatoumata
Backup ContactClaire FOUGEROU-LEURENT
Outcome results
None listed