Primary Objective: To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV (hepatitis B virus) treatment
Secondary Objective(s): 1. Describe persistence of ALT (alanine aminotransferase) normalization and/or improvement of ALT levels with TAF as with previous anti-HBV treatment 2. To describe trends in serum creatinine and calculated creatinine clearance as available by local labs. 3. To describe trends in bone mass from baseline to 24 months after switch. https://med.stanford.edu/nguyenlab/clinical-trials.html
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Tenofovir alafenamide (TAF) is a new formulation of tenofovir with higher intracellular active drug concentration allowing for dosing of only 25 mg once daily and thus can potentially lower the already low risk of renal toxicity and bone loss with tenofovir disoproxil fumarate (TDF).
Stanford University Medical Center
Palo Alto, California, United States
San Jose Gastroenterology
San Jose, California, United States
Kyushu University Hospital
Fukuoka, Japan
Number of Participants With HBV DNA <20 IU Per mL
To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV treatment.
Time frame: Baseline, 6, 12, 18, 24 months
Number of Participants With Normal Alanine Aminotransferase (ALT).
Alanine aminotransferase (ALT) normalization is defined if ALT was less than 35 U/L for men or 25 U/L for women
Time frame: Baseline, 6, 12, 18, 24 months
Calculated eGFR
To describe trends in calculated eGFR as available by local labs. Estimated glomerular filtration rates (eGFR) were calculated using the Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI) equation (eGFR \[mL∕min∕1.73m2\] =141 × \[minimum Scr∕K, 1\]α × \[maximum Scr/K, 1\]1.209 × 0.993age × 1.018 \[if female\] × 1.159 \[if black\]) where Scr is serum creatinine in µmol/L, K is 61.9 for females and 79.6 for males, α is -0.329 for females and -0.411 for males
Time frame: Baseline, 6, 12, 18, 24 months
The Mean Bone Mass Density (T-score) Change
To describe trends in bone mass density from baseline to end of study. Bone Mass Density(BMD) was evaluated using T-score of Lumber-spine. The T-score is a comparison of the results to a average peak bone mass of healthy young adult. 0 indicates healthy young adult's mean with a SD of 1. Normal BMD was defined with T-score of -1.0 or above; osteopenia with T-score between -1.1 and -2.4, and osteoporosis with T-score of -2.5 or below (ref). Worsened BMD was defined by upstaging of BMD class from normal to osteopenia or worse or from osteopenia to osteoporosis. Improved BMD was defined by downstaging of BMD class from osteopenia to normal or osteoporosis to osteopenia or normal.
Time frame: Baseline, month 24
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Nagoya City University
Nagoya, Japan
Osaka City University
Osaka, Japan
Saga University Hospital
Saga, Japan
Hanyang University Seoul Hospital
Seoul, South Korea
Nowon Eulji Medical Center, Eulji University College of Medicine,
Seoul, South Korea
Sanggye Paik Hospital, Inje University College of Medicine
Seoul, South Korea
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
...and 2 more locations