Conditions: Chronic Hepatitis B
Keywords: stopping oral antiviral therapy HBsAg loss seroconversion restarting oral antiviral therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 43
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants randomized to this arm will stop TDF therapy at baseline. arm 2: Participants randomized to this arm will continue TDF therapy.

Interventions: intervention 1: TDF intervention 2: Stop TDF
Intervention descriptions: intervention 1: Tenofovir disoproxil fumarate (TDF) 300 mg tablet administered orally once daily intervention 2: Participants will stop TDF therapy

Protocol document: