The Effect of Entecavir Consolidation on Post-TDF Treatment Durability

• Status: Not yet recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Clinical relapse occurred much earlier and tended to be more severe after cessation of TDF than ETV. The follow-up interval and intensity would be different between ETV and TDF after discontinuation of therapy. Whether switch therapy from TDF to ETV can modify the pattern of relapse is interesting but unclear. Our hypothesis is that entecavir consolidation on post-TDF treatment patients reduce and delay the clinical relapse effectively. Hence in this proof of concept study we would like to evaluate the effect of 6 months and 12 months of entecavir consolidation on post-TDF treatment durability.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: Chang Gung Memorial Hospital; Changhua Christian Hospital; China Medical University Hospital
• Treatments: Entecavir

Criteria

Inclusion Criteria:

• >20 yrs old.

• No history of Lamivudine or telbivudine resistance.

• HBsAg positive for more than 6 months.

• HBeAg (-).

• HBeAg-negative CHB under TDF treatment for mora than 2 years and fulfilled APASL 2012 guideline's stopping rule: HBeAg (-): undetectable HBV DNA on 3 separate occasions at least 6 months apart.

Exclusion Criteria:

• Lamivudine/telbivudine resistance.

• HBeAg (+).

• HIV, HCV co-infection.

• Under immunosuppressant treatment (including steroid and biologics).