HBV
Conditions
Keywords
HBV reactivation, Immunosuppressive therapy
Brief summary
Background/Objective: Comorbidities represent a critical risk factor in the prognosis of patients receiving immunosuppressive therapy. For patients with anti-HBc IgG positivity requiring Hepatitis B virus (HBV) prophylaxis, the long-term physiological impact of oral antivirals remains a concern. This study aims to prospectively monitor bone, renal, and metabolic dysfunctions associated with oral antiviral use and other systemic risk factors over a long-term period. Methods: The REANT Cohort is designed as a 4-year, multicenter prospective study. The cohort will consist of patients initiated on HBV prophylaxis due to immunosuppressive treatment. Participants will undergo regular longitudinal assessments to evaluate bone mineral density, renal filtration and tubular functions, and metabolic profiles. The interplay between antiviral therapy, baseline comorbidities, and long-term organ dysfunction will be analyzed. Conclusion: The findings from the REANT Cohort are expected to provide robust evidence regarding the safety of long-term HBV prophylaxis and assist in the development of monitoring guidelines for immunosuppressed patients with latent HBV infection.
Detailed description
Patient Recruitment and Enrollment: The patient enrollment phase for the study is scheduled to conclude on June 30, 2026. Each participating center is projected to enroll 35 patients, ensuring a balanced distribution of data across the multicenter framework. The study will be initiated simultaneously across all participating sites to maintain temporal consistency in data collection. Electronic Case Report Form (e-CRF) and Coding: Data will be managed through a centralized e-CRF system. To ensure systematic tracking and data integrity, the system will assign a unique center code to each participating institution. Patient Identification and Confidentiality: For each participant, a specific patient code will be automatically generated by the system. Following the standardized protocol of the study, the patient's Full Name must be entered into the system, formatted specifically with a hyphen between the first and last name (e.g., John-Doe). This structured nomenclature will ensure uniformity in the electronic database.
Interventions
DRUGAntiviral
Patients who take all antivirals recommended in the guidelines will be evaluated in the same group.
Sponsors
Yaşar Bayındır, MD
SOUTHEAST NEUROLOGY AND INFECTIOUS DISEASES SOCIETY
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older * Positive for Anti-HBc IgG * Must be candidate for immunosuppressive therapy.
Exclusion criteria
* Voluntary Withdrawal * Failure to attend follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring of renal function in patients receiving antivirals. | Baseline to week 6, 12, 24, 48 | To assess the composite changes in renal function (GFR decline, proteinuria, etc) from baseline to month 48. |
| Monitoring of bone health in patients receiving antivirals. | Baseline to week 6, 12, 24, 48 | To assess the composite changes in bone health (Reduction in T-scores via DEXA) from baseline to month 48. |
| Monitoring of metabolic status in patients receiving antivirals. | Baseline to week 6, 12, 24, 48 | To assess the composite changes in metabolic status (HOMA-IR elevation, lipid profile alterations, etc) from baseline to month 48. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of liver status in the patients receiving HBV antivirals. | Baseline to week 6, 12, 24, 48 | To evaluate changes in liver status by FIB-4 over 48 months. FIB-4 Index (Fibrosis-4 Index) is a formula that combines four different parameters to estimate the degree of liver damage. These parameters are: Age, AST (Aspartate Aminotransferase) level, ALT (Alanine Aminotransferase) level, and platelet count. |
| Evaluation of liver damage in the patients receiving HBV antivirals. | Baseline to week 6, 12, 24, 48 | To evaluate changes in liver status by APRI over 48 months. APRI (AST to Platelet Ratio Index) is a simpler calculation focusing on the relationship between liver enzyme elevation and the decrease in platelets often seen as liver disease progresses. Parameters Used: AST level, AST Upper Limit of Normal (ULN), Platelet Count. |
| Evaluation of liver stiffness in the immunosuppressive patients receiving HBV antivirals for reactivation prophylaxis. | Baseline to week 6, 12, 24, 48 | To evaluate changes in liver status by Fibroscan (if available in the center) over 48 months. FibroScan (also known as Transient Elastography) is a non-invasive medical imaging technique used to measure the stiffness of the liver. |
Countries
Turkey (Türkiye)
Contacts
CONTACTCigdem Mermutluoglu, MD, Assoc. Prof.
CONTACTMustafa Kemal Celen, MD, Prof.
STUDY_DIRECTORYasar Bayındır, MD, Prof.
Guven Hospital
PRINCIPAL_INVESTIGATORcigdem Mermutluoglu
Dicle University, Medical Faculty
Outcome results
None listed