Health Condition 1: K77- Liver disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Tenofovir Alafenamide Fumarate: TAF once daily for 5 years per oral
Control Intervention1: No intervention: No intervention
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. HBsAg+ 2. Persistent normal ALT 3-6m apart ( 3. HBV DNA 4. LSM
Exclusion criteria
Exclusion criteria: 1.Prior NUC/IFN exposure. 2.Renal dysfunction (Serum Creatinine >1.5 mg/dl). 3.Known liver cirrhosis/ esophageal varices. 4.Any clinical decompensation (CD). 5.Pre-existing hepatocellular carcinoma. 6.Pregnancy 7.Healthcare workers (HCW). 8.Post transplant, patients with advance malignancy or on chemotherapy. 9.Co-infections ââ?¬â?? Hepatitis C, Hepatitis D, Human immunodeficiency virus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with HBV DNA less than 2000 IU/ml, normal ALT and no significant fibrosis (as per APASL 2015) Any two of the following ââ?¬â?? 1. Significant fibrosis (LSM more than 8 Kpa or APRI more than 1.5) 2. Persistently elevated ALT (2 consecutive ALT more than 30 U/ml 3-6m apart) 3. HBV DNA more than 2000 IU/ml Timepoint: upto 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| DeathTimepoint: upto 5 years;Incidence of HCCTimepoint: upto 3 years and 5 years;Log HBsAg reductionTimepoint: upto 5 years;No progression of fibrosis (reduction in LSM value)Timepoint: upto 5 years;Non-compliant to treatment or monitoringTimepoint: upto 5 years;Percentage of patients with ALT more than ULN, more than 2 times and 5 times ULNTimepoint: upto 5 years;Percentage of patients with APRI score more than 1.5 and more than 2Timepoint: upto 5 years;Percentage of patients with HBeAg loss and HBeAg seroconversion in HBeAg positive chronic hepatitis BTimepoint: upto 5 years;Percentage of patients with HBsAg loss and HBsAg seroconversionTimepoint: upto 5 years;Percentage of patients with HBV DNA more than 2000 IU/mlTimepoint: upto 5 years;Percentage of patients with LSM more than 11 Kpa (cirrhosis)Timepoint: upto 5 years;Percentage of patients with LSM more than 8 Kpa (significant fibrosis)Timepoint: upto 5 years;Percentage of patients with undetectable HBV DNATimepoint: upto 5 years;Treatment related adverse effects of TAFTimepoint: upto 5 years;Treatment related severe adverse effectsTimepoint: upto 5 years | — |
Countries
India
Contacts
Public ContactDr Ankur Jindal
Institute of Liver and Biliary Sciences
Outcome results
None listed