HBV
Conditions
Brief summary
After fulfillment of the selection criteria, all the patients included in the trial will be administered Tenofovir that will be continued for 3 months and then stopped for 1 month, LFT's, HBV DNA, HBsAg, will be checked weekly during the time period of stopping Tenofovir and thereafter at 4 months patients with ALT \>/= 1.5 times ULN will be randomised in 2 groups to administer either Peg INF alpha 2b + Tenofovir (in same dose as before) or Tenofovir alone which will be continued for 48 weeks and the patients with no rise in ALT will be excluded. Patients will be closely monitored during the period of stopping tenofovir post pulse therapy and liver function tests will be performed weekly. Patients will be closely observed for the development of acute hepatitis or decompensation during the 4 - week period of drug withdrawal. Thereafter, CBC, KFT, LFT's, PT-INR, HBsAg (Q), HBeAg and HBV DNA levels will be tested every 3 months. After stopping treatment followup will be done at 24 weeks post stoppage of treatment to look for sustained seroconversion and virological/biochemical response
Interventions
DRUGTenofovir + Interferon alpha 2b
DRUGTenofovir disoproxil Fumarate
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Treatment naive chronic HBV infection i.e detectable HBsAg for past 6 months, 2. HBeAg (+), 3. ALT \< ULN (Upper Limit Normal) on 2 or more occasions in last 6 months \[ULN: 45\] 4. HBV DNA \>2000 IU/mL 5. Age \> 18 years
Exclusion criteria
1. Decompensated Cirrhosis 2. Severe HBV flare with reactivation 3. Presentation as ACLF (Acute on Chronic liver Failure) 4. Baseline ALT \> ULN (Upper Limit Normal) 5. Contraindications to PEG-IFN therapy 6. Prior HBV antiviral therapy within 6 months of enrollment 7. Co-infections with HCV/HIV 8. ANA +(autoantibodies suggestive of autoimmune disease) \>1:80 9. Patient not willing for enrollment in the study 10. Pregnancy, lactation 11. Patients who leave the study/ discontinue the therapy before completion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained [ 6 months after stopping treatment] HBeAg seroconversion to anti-Hbe on two consecutive assays, at least 1 month apart | 65 weeks |
Secondary
| Measure | Time frame |
|---|---|
| HBsAg loss | 64 weeks |
| Absence of quantifiable serum HBV DNA | 64 weeks |
| Development of serious adverse effects, acute hepatitis or hepatic decompensation | 64 weeks |
Countries
India
Outcome results
None listed