This is an open-label, single arm cohort study to see efficacy and safety of tenofovir disoproxil fumarate (TDF) in naïve chronic hepatitis B, retrospectively and prospectively both.
Study Type
OBSERVATIONAL
Enrollment
572
The Catholic University of Korea, Daejeon St.Mary's Hosptial
Junggu, Daejeon, South Korea
The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48
proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48
Time frame: week 48
The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 96
proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 96
Time frame: Week 96
The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at every visits
The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at every visits
Time frame: week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
The proportion of the biochemical (alanine aminotransferase normalization) response of TDF for the treatment of chronic hepatitis B at Week 48 and 96
The proportion of the biochemical (alanine aminotransferase normalization) response of TDF for the treatment of chronic hepatitis B at Week 48 and 96
Time frame: Week 48 and 96
The proportion of the serological response (loss of HBeAg and seroconversion to HBeAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96
The proportion of the serological response (loss of HBeAg and seroconversion to HBeAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96
Time frame: Week 48 and 96
The proportion of the serological response (loss of HBsAg and seroconversion to HBsAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96
The proportion of the serological response (loss of HBsAg and seroconversion to HBsAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Week 48 and 96
The change from baseline in the decline of HBV DNA at every visits
The change from baseline in the decline of HBV DNA at every visits
Time frame: week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144
The proportion of patients showing virological breakthrough at week 48 and 96
The proportion of patients showing virological breakthrough at week 48 and 96. Virological Breakthrough defined as any increase in serum HBV DNA by \>1 log10 from nadir or redetection of serum HBV DNA at levels ≥10-fold the lower limit of detection of the HBV DNA assay after having an undetectable result
Time frame: Week 48 and 96
The incidence of resistance of TDF among patients showing virological breakthrough at week 48 and 96
The incidence of resistance of TDF among patients showing virological breakthrough at week 48 and 96. Virological Breakthrough defined as any increase in serum HBV DNA by \>1 log10 from nadir or redetection of serum HBV DNA at levels ≥10-fold the lower limit of detection of the HBV DNA assay after having an undetectable result
Time frame: Week 48 and 96
The proportion of improvement of liver function including Child Score, Model for End-stage Liver Disease (MELD) score at Week 48 and 96
The proportion of improvement of liver function including Child Score, MELD score at Week 48 and 96
Time frame: Week 48 and 96
The proportion of improvement of Fibrosis marker including Aspartate aminotransferase to Platelet Ratio Index(APRI) at Week 48 and 96
The proportion of improvement of Fibrosis marker including Aspartate aminotransferase to Platelet Ratio Index(APRI) at Week 48 and 96
Time frame: Week 48 and 96