None listed
Conditions
Brief summary
The aim of treatment for HBV is to suppress viral replication and to prevent the emergence of complications and to ultimately clear the virus and produce seroconversion with Antibodies to Hepatitis Bs (anti-HBs). Achieving this goal requires long-term therapy. Monotherapies have found to be insufficient in most chronic viral diseases. Analysis of the primary endpoint will be summarised by the proportion of subjects meeting the endpoint for each treatment arm (the primary endpoint is to supress the viral load below the limit of detection by week 48). The study hypothesis is that there will be a difference between treatment groups in the proportion of subjects with HBV DNA below the detectable level at week 48.
Interventions
The current study will be looking at the efficacy, safety and tolerability of tenofovir DF monotherapy versus the once-daily combination of tenofovir DF plus emtricitabine in patients who have chronic Hepatitis B Virus [Hepatitis B e Antigen (HBeAg) negative or positive disease]. Subjects will be randomized in a 1:1 ratio to treatment arms A or B.
The current study will be looking at the efficacy, safety and tolerability of tenofovir DF monotherapy versus the once-daily combination of tenofovir DF plus emtricitabine in patients who have chronic Hepatitis B Virus [Hepatitis B e Antigen (HBeAg) negative or positive disease]. Subjects will be randomized in a 1:1 ratio to treatment arms A or B. Tenofovir DF 300 mg will be provided open-label while emtricitabine 200 mg will be provided in a blinded fashion: Treatment B: Open label tenofovir DF 300 mg once daily +emtricitabine 200 mg once daily. Subjects will be instructed to take 1 pill from each bottle once daily: one tablet (open label tenofovir DF) and one capsule (emtricitabine 200 mg). All subjects will continue on study medication until Week 48. At Week 48, Gilead Sciences will provide open label tenofovir DF 300 mg for study subjects in countries where the drug is not commercially available, until such access is available. Subjects who wish to discontinue therapy will be followed off treatment for 24 weeks or until the initiation of alternate commercial therapy.
Sponsors
Gilead
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
To be eligible for participation, at screening subjects with chronic Hepatitis B Virus (HBV) infection [Hepatitis B Surface Antigen (HBsAg) > 6 months or HBsAg positive > 3 months and negative for Immunoglobulin M (IgM), Antibodies to Hepatitis B Core Antigen (anti-HBc) and positive for Immunoglobin G (IgG) anti-HBc], HBV DNA levels > or = 10^8 copies/mL, Alanine Transferase (ALT) levels > or = Upper Limit of Normal (ULN), creatinine clearance > or = 70 mL/min, alpha-fetoprotein < 50 ng/mL.
Exclusion criteria
Subjects must be naïve to oral HBV therapy and without serological evidence of co-infection with Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), or Hepatitis D Virus (HDV). Previous treatment with interferon must have ended at least 6 months prior to the screening visit. Subjects with decompensated liver disease as well as pregnant or breast-feeding females will be excluded from the study. Regular visits will involve the review of vital signs and collection of blood to perform routine lab tests of serum chemistry, liver tests, hematology and HBV DNA. Tests specific to HBV and a physical examination will be done at specific visits. A sample of urine will also be collected at each visit for urinalysis and a urine pregnancy test will be requested for females of child bearing potential.
Outcome results
None listed