Hepatitis B infection Infections and Infestations Hepatitis B
Conditions
Interventions
Patients will be given Tenofovir 300mg daily (orally) for 52 weeks and then lamivudine 100mg (orally) daily for 26 weeks. Patients will be followed up for 6 months after starting lamivudine.
Sponsors
Queen Mary University of London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HBV viral load >105 copies/ml 2. Alanine aminotransferase (ALT) >1.3 times upper limit of normal (which sets the criterion at 45 i.u./l) 3. Evidence of inflammation on liver biopsy 4. May be either e antigen negative (n=40) or positive (n=40)
Exclusion criteria
Exclusion criteria: 1. Histological or radiological evidence of cirrhosis 2. HIV infection 3. History of alcohol abuse or histological evidence of alcoholic liver disease 4. History of any long-term drug ingestion 5. Histological evidence of metabolic liver disease (haemochromatosis, Wilson?s disease, a1-antitrypsin deficiency) or autoimmune liver disease [antibodies to M2 antigen, Perinuclear antineutrophil cytoplasmic antibodies (p-ANCA), nuclear antigens, microsomes or smooth muscle] 6. Histological or radiological evidence of schistosomiasis 7. Histological evidence of hepatitis D virus (HDV) infection 8. Virological evidence of active hepatitis C virus (HCV) or hepatitis E virus (HEV) infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who successfully step down to lamivudine monotherapy with virological control of replication throughout | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients who, even if there is virological rebound, achieve successful control on re-introduction of tenofovir 2. Accuracy of ALT monitoring in comparison with viral load monitoring 3. Accuracy of HBsAg quantification compared to viral load monitoring The primary and secondary outcomes will be assessed by virological measurements in blood samples obtained every 3 months. | — |
Countries
Zambia
Outcome results
None listed