Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB
Status:
Completed
Trial end date:
2016-08-23
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss
and seroconversion in participants who stop tenofovir disoproxil fumarate (TDF) (Stop TDF
arm) compared to participants who continue TDF (Continue TDF arm).
Only participants who already are on treatment with TDF monotherapy or TDF in combination
with lamivudine or emtricitabine for at least 4 years and who achieved and maintained
virologic suppression (< 400 copies/mL) for 3.5 or more years will be included in this study.
One treatment arm will stop the TDF therapy while the other treatment arm will continue the
TDF therapy. Participants in the Stop TDF arm will be monitored very closely with special
focus on biochemical flares (especially alanine aminotransferase (ALT) increases) and
virological relapses (Hepatitis B viral load increases). If any participant in the Stop TDF
arm exceeds one or more predefined limits for such flares or relapses, TDF treatment will be
reinstituted.