Switching From Tenofovir Disoproxi Fumarate to Tenofovir Alafenamide in Chronic Hepatitis B Patients With Antiviral Resistance
Not Applicable
Not yet recruiting
- Conditions
- Certain infectious and parasitic diseases
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
1. Adult (male and female) subjects above 20
2. Diagnosed as chronic hepatitis B
3. Patients treated with TDF monotherapy or TDF-based combination therapy, or those who converted to TAF within 4 weeks prior to screening during TDF treatment for antiviral-resistance
4. Patients who want voluntary participation in this study
Exclusion Criteria
Co-infection with HIV or HCV
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of subjects who achieve a sustained serum HBV DNA level < 20 IU/mL (undetectable serum HBV DNA by PCR) at week 48 during the on-treatment follow-up period.
- Secondary Outcome Measures
Name Time Method The percent change in hip and spine BMD from baseline;The change in serum eGFR from baseline;The proportion of patients achieving or maintaining virological suppression (HBV DNA level < 20IU/mL);The change in serum creatinine and PO4 level from baseline