Health Condition 1: B181- Chronic viral hepatitis B withoutdelta-agent
Conditions
Interventions
Intervention1: Stopped Therapy: Arm A Group Stopped Medication During Study Period Which Were Taking Earlier Either Tenofovir or Entecavir
Control Intervention1: Continuing Medication: Arm B Group Wil
Sponsors
National Health Mission
Eligibility
Inclusion criteria
Inclusion criteria: 1 Adult Patients( Age 18-65 Years) with e Antigen Negative Chronic Hepatitis B 2 Continuous Tenofovir or Entecavir Monotherapy for at least 2 Years 3 HBV DNA 4 Sustained Viral Suppression ( at Least 3 Report of HBV DNA at 6 Months Interval Showing Undetectable Viral Load)
Exclusion criteria
Exclusion criteria: 1 Patients with significant fibrosis ( Fibroscan >8 Kpa LSM or Liver Biopsy or USG Abdomen shows Cirrhosis, APRI >1.5, FIB4 >3.25 2 Immunocompromised 3 HCC 4 Pregnancy 5 Co-Infection 6 Patient Who Received Dual Antivirals or PEG INF 7 Patients on Lamivudine or Adefovir 8 Patient not Willing to Participate in the Study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To Evaluate Hbs Ag Loss And Changes in Hbs Ag Titer in Patient Who Stop Antiviral Therapy as Compared to Patients Who Continue Treatment at 24 Months.Timepoint: Hbs Ag and Anti Hbs Measures in Every 6th Monthly or When Needed | — |
Primary
| Measure | Time frame |
|---|---|
| 1.To Assess the Off Therapy Clinical and Virological Response following Cessation of Oral Antiviral Medication at 6,12,18,24 months. 2. Off Therapy Immunological Changes with Effects on CD8+ T cells, CD4+ T Cells, NK Cells and Different Cytokines Level. Timepoint: 1. ALT Will be Carried Out in Every 3 Months During The Period of 24 Months. 2. HBV DNA Measure in Every 6th Monthly to Assess Virological Response or when needed. 3. Immunological Changes in Every 6th Monthly. | — |
Countries
India
Contacts
Public ContactNagrale Vivek Bhaurao
IPGMER And SSKM Hospital
Outcome results
None listed