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This observational study will be conducted in patients with chronic co-infection with hepatitis B and D viruses, with negative PCR for HDV RNA in peripheral blood and no signs of active liver inflammation according to blood chemistry parameters, receiving background therapy with bulevirtide for more than 48 weeks and liver biopsy performed or prescribed to be performed as part of routine practice.
After the patient has signed the Informed Consent, a portion of the liver biopsy collected as part of routine practice will be sent to the laboratory for PCR testing for HDV RNA, background therapy with bulevirtide will be interrupted, and the patient will be observed in the clinic in accordance with routine medical practice, but at least once times every 4 weeks, for timely detection of relapse of the hepatitis D and initiation of antiviral therapy. Once a relapse of viral hepatitis D is determined via the PCR HDV RNA, the patient's participation in the study will be terminated.
The collected data will be analyzed to assess the probability of relapse-free over time. Separate tests will also be conducted for subgroups of patients based on covariates such as duration of previous background therapy with bulevirtide, duration of HDV suppression, use of any other concomitant antiviral therapy during bulevirtide treatment.
The main goal of this study is the following:
- To assess the probability of HDV relapse-free over time after discontinuation of background therapy with bulevirtide in patients with chronic co-infection with hepatitis B and D viruses and negative PCR HDV RNA
Primary endpoint: Occurrence of hepatitis D viral relapse.
Additional objectives in this study:
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| Measure | Description | Time Frame |
|---|---|---|
| Probability of HDV relapse-free over time | To assess the probability of HDV relapse-free over time discontinuation of background therapy with bulevirtide in patients with chronic co-infection with hepatitis B and D viruses and negative PCR HDV RNA | 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Probability of HDV relapse-free over time and the duration of previous background therapy with boulevertide | Analyze the probability of HDV relapse-free over time and the duration of previous background therapy with boulevertide | 96 weeks |
| Probability of HDV relapse-free over time and the duration of the period of HDV suppression |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic co-infection with hepatitis B and D viruses with negative PCR HDV RNA who meet inclusion/exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Target Therapy | Moscow | 125008 | Russia |
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| ID | Term |
|---|---|
| D019701 | Hepatitis D, Chronic |
| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
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Analyze the probability of HDV relapse-free over time and the duration of the period of HDV suppression |
| 96 weeks |
| Probability of HDV relapse-free over time and the use of any other concomitant antiviral therapy during the period of treatment with bulevirtide | Analyze the probability of HDV relapse-free over time and the use of any other concomitant antiviral therapy during the period of treatment with bulevirtide | 96 weeks |
| Relapse-free patients over 96 weeks | Analyze HDV relapse-free patients over 96 weeks | 96 weeks |
| Results of qualitative PCR HDV RNA in a liver biopsy | Analyze the results of qualitative PCR HDV RNA (positive / negative) in a liver biopsy before discontinuing bulevirtide therapy | Baseline (At the time of the patient inclusion) |
| D012327 |
| RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |