This study is a multi-center, prospective, real-world study, males and non-pregnant, non-lactating female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.
This study is a multi-center, prospective, real-world study, aiming to investigate the use of TAF in routine clinical management of chronic hepatitis B patients and evaluate its effectiveness and safety across a heterogeneous population in China. Approximately 500 patients will take part in this study, 10 sites will be included which distribute in China's major cities, thus each site will enroll 50 patients. Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.
Study Type
OBSERVATIONAL
Enrollment
500
The dose of tenofovir alafenamide (TAF) will be 25mg tablet taken orally once daily with food for 36 months, patients will be treated with TAF alone or in combination with anti-HBV agents
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGShulan(Hangzhou) hospitai
Hangzhou, China
RECRUITINGFirst Affiliated Hospital of Nanchang University
Nanchang, China
proportion of participants with HBV DNA < 20 IU/mL
proportion of participants with HBV DNA \< 20 IU/mL as measured by the COBAS TaqMan HBV Test (Roche Molecular Diagnostics, Pleasanton, CA, USA), with taken at 36 months
Time frame: 36 months
The proportion of patients with HBV DNA < 20 IU/mL
The proportion of patients with HBV DNA \< 20 IU/mL at 12 months
Time frame: 12 months
The proportion of patients with HBV DNA <300 copies/mL
The proportion of patients with HBV DNA \<300 copies/mL at 12 months
Time frame: 12 months
The proportion of patients with HBV DNA < 20 IU/mL
The proportion of patients with HBV DNA \< 20 IU/mL at 24 months
Time frame: 24 months
The proportion of patients with HBV DNA <300 copies/mL IU/mL
The proportion of patients with HBV DNA \<300 copies/mL at 24 months
Time frame: 24 months
The proportion of patients with HBV DNA <300 copies/mL IU/mL
The proportion of patients with HBV DNA \<300 copies/mL at 36 months
Time frame: 36 months
Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss
Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss at 36 months
Time frame: 36 months
Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe)
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Shanghai public health clinic
Shanghai, China
RECRUITINGGeneral Hospital of The Yangtze River Shipping
Wuhan, China
NOT_YET_RECRUITINGThe Seventh Hospital of Wuhan
Wuhan, China
RECRUITINGXiangya Hospital of Central South University
Xiangya, China
RECRUITINGProportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe) at 36 months
Time frame: 36 months
Proportion of participants with Normal Alanine Aminotransferase (ALT)
Proportion of participants with Normal Alanine Aminotransferase (ALT) at 36 months
Time frame: 36 months
Change from baseline in fibrosis as assessed by Fibroscan®
Change from baseline in fibrosis as assessed by Fibroscan® at 36 months
Time frame: 36 months
Percent Change from baseline in Bone Mineral Density (BMD)
Percent Change from baseline in Bone Mineral Density (BMD) at 36 months
Time frame: 36 months
Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG)
Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at 36 months
Time frame: 36 months
the rate of mother-to-child transmission of HBV
For unplanned pregnant subjects, if not withdrawn, mother-to-child transmission (MTCT) rate
Time frame: at postpartum 6 months