This study evaluates the efficacy and safety of switching to Tenofovir Disoproxil from Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients who pretreated with Tenofovir Disoproxil Fumarate. In Open-Label, phase 3 studies, we randomly assigned patients with hepatitis B e antigen (HBeAg)-negative or HBeAg-positive chronic HBV infection to receive Tenofovir Disoproxil or Tenofovir Disoproxil Fumarate (ratio, 2:1) once daily for 48 weeks
Tenofovir Disoproxil and Tenofovir Disoproxil Fumarate is a nucleotide analogue and a potent inhibitor of human immunodeficiency virus type 1 reverse transcriptase and hepatitis B virus (HBV) polymerase. The primary efficacy end point at week 48 of this study was defined as the combination of an HBV DNA level of less than 400 copies per milliliter and histologic improvement .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
189
Viread 300mg
Virehepa 245mg
Asan Medical Center
Seoul, South Korea
HBV DNA inhibition
plasma HBV DNA level of less than 400 copies per milliliter
Time frame: 48weeks
viral suppression
an HBV DNA level of \<400 copies per milliliter
Time frame: 24weeks
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