Conditions: Hepatitis B
Keywords: Tenofovir DF Emtricitabine Chronic hepatitis B Combination therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 280
Healthy volunteers: no

Brief summary:
The aim of therapy for the treatment of chronic hepatitis B virus (HBV) is to maintain suppression of viral replication to prevent the emergence of complications, which requires long-term therapy. Durable suppression of viral replication is achieved in the treatment of chronic viral diseases by preventing of the emergence of drug-resistant mutations. The clinical guidelines for the management of lamivudine resistant patients are variable. Some recommend switching to another agent without cross-resistance, while others recommend adding on another agent without cross-resistance. Limited clinical data exists to demonstrate whether tenofovir disoproxil fumarate (tenofovir DF; TDF) is an effective monotherapy for lamivudine resistant patients or if it should be used as part of a combination therapy regimen.

This study is designed to evaluate the effectiveness, safety, and tolerability of tenofovir DF monotherapy versus emtricitabine (FTC)/tenofovir DF combination therapy in participants with chronic HBV with lamivudine resistance (presence of the rtM204I/V mutation with or without the rtL180M mutation) over a 240-week period. Participants in this study must be receiving lamivudine treatment at the time of enrollment.

Detailed description:

Arms:
arm 1: TDF plus placebo to match FTC/TDF arm 2: FTC/TDF plus placebo to match TDF

Interventions: intervention 1: TDF intervention 2: FTC/TDF intervention 3: TDF Placebo intervention 4: FTC/TDF Placebo
Intervention descriptions: intervention 1: Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet administered orally once daily intervention 2: Emtricitabine (FTC)/TDF 200/300 mg fixed-dose combination tablet administered orally once daily intervention 3: TDF placebo tablet administered orally once daily intervention 4: FTC/TDF placebo tablet administered orally once daily

Protocol document: