Conditions: Chronic Hepatitis B
Keywords: Chronic Hepatitis B Hep B Non cirrhotic Tenofovir disoproxil fumarate (TDF) Peginterferon α-2a (Peg-IFN)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 751
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen (HBsAg).

The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment, participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and those meeting TDF retreatment and flare management criteria will be eligible to receive TDF monotherapy during a retreatment phase, up to Week 120.

Detailed description:

Arms:
arm 1: TDF plus Peg-IFN for 48 weeks arm 2: TDF plus Peg-IFN for 16 weeks, followed by TDF alone for an additional 32 weeks arm 3: TDF monotherapy for 120 weeks arm 4: Peg-IFN monotherapy for 48 weeks

Interventions: intervention 1: TDF intervention 2: Peg-IFN
Intervention descriptions: intervention 1: TDF 300 mg tablets administered orally once daily intervention 2: Peg-IFN 180 µg administered via subcutaneous injection once weekly

Protocol document: