Conditions: Chronic Hepatitis B
Keywords: tenofovir monotherapy emtricitabine combination hepatitis B
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 126
Healthy volunteers: no

Brief summary:
The main objective of the study was to evaluate the antiviral activity of tenofovir disoproxil fumarate (tenofovir DF) monotherapy versus emtricitabine (FTC) plus tenofovir DF combination therapy for the treatment of chronic hepatitis B (HBV) in participants in the immune tolerant phase of HBV infection.

The efficacy of tenofovir DF monotherapy versus FTC plus tenofovir DF combination therapy was evaluated for suppression of the virus (decrease in HBV DNA), serological response (generation of antibodies to the virus), biochemical response (changes in liver enzymes), and the development of drug-resistant mutations. The safety and tolerability of both tenofovir DF monotherapy and FTC plus tenofovir DF were evaluated by routine monitoring for adverse events and changes in laboratory parameters.

Participants were randomized in a 1:1 ratio to receive tenofovir DF monotherapy or FTC plus tenofovir DF. All subjects were to continue on blinded study medication until the last subject reached Week 192. Participants who permanently discontinued study drug (on or before Week 192) were followed for a 24-week treatment-free follow-up period, or until initiation of alternative HBV therapy, whichever occurred first. Subjects who discontinued study drug on or after Week 48 because of hepatitis B surface antigen (HBsAg) loss or seroconversion to antibody to hepatitis B surface antigen (anti-HBs), however, were to have returned for their regularly scheduled through Week 192 and every 16 weeks thereafter until the last subject reached Week 192.

Detailed description:

Arms:
arm 1: Participants were randomized to receive tenofovir DF plus placebo to match FTC once daily. arm 2: Participants were randomized to receive FTC plus tenofovir DF once daily.

Interventions: intervention 1: Tenofovir DF intervention 2: FTC intervention 3: Placebo
Intervention descriptions: intervention 1: Tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablet taken orally once daily intervention 2: Emtricitabine (FTC) 200 mg capsule taken orally once daily intervention 3: Placebo to match FTC taken once daily

Protocol document: