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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Tenofovir disoproxil fumarate (TDF) 300 mg tablet administered orally once daily
Participants will stop TDF therapy
Leberzentrum am Checkpoint
Berlin, Germany
Charite CVK
Berlin, Germany
Zentrum für HIV und Hepatitis
Düsseldorf, Germany
J.W. Goethe Universitaetsklinikum
Frankfurt, Germany
ifi Studien und Projekte GmbH
Hamburg, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitaetsklinik Heidelberg
Heidelberg, Germany
Gastroenterologische Gemeinschaftspraxis
Herne, Germany
Universitaetsklinikum Leipzig
Leipzig, Germany
...and 3 more locations
Proportion of Participants With HBsAg Loss at Week 144 in Both Study Arms
HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Time frame: Week 144
Proportion of Participants With HBsAg Seroconversion in Both Study Arms at Weeks 96 and 144
HBsAg seroconversion is defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit. Proportions are based on the Kaplan-Meier estimate.
Time frame: Weeks 96 and 144
Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms
* The analyses were summarized by 3 treatment subgroups: Stop TDF (TDF-Free), Restart TDF, and Continue TDF * When participant randomized in the Stop TDF group restarted TDF therapy, that participant was considered part of the Restart TDF group from that point forward. For Restart TDF group, baseline is defined as the last available record on or prior to the restart date of TDF.
Time frame: Baseline to Week 144
Proportion of Participants Who Restart TDF Therapy in the Stop TDF Arm
Time frame: Weeks 48, 96, and 144
Percentage of Participants With Viral Suppression in the Stop TDF Arm (TDF-Free and Re-Start TDF Groups)
Viral suppression is defined as 2 consecutive assessments of HBV DNA \< 400 copies/mL (69 IU/mL) through Week 144.
Time frame: Baseline to Week 144
Percentage of Participants With Alanine Aminotransferase (ALT) > Upper Limit of the Normal Range in the Stop TDF Arm (TDF-Free and Restart TDF)
Time frame: Baseline to Week 144
Proportion of Participants With HBsAg Loss at Week 96 in Both Study Arms
HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Time frame: Week 96
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