Hepatitis B, Viral Hepatitis
Conditions
Keywords
Hepatitis B, Viral Hepatitis, Tenofovir alafenamide, Entecavir
Brief summary
To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.
Detailed description
With high antiviral potency and low drug resistance rate, both ETV and tenofovir disoproxil fumarate (TDF) have been recommended as the first-line antiviral therapy for chronic hepatitis B (CHB). However, risk of renal dysfunction remains an issue in TDF long-term therapy. Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir and is formulated to deliver the active metabolite to target cells more efficiently than TDF at lower doses, thereby reducing systemic exposure to tenofovir. Importantly, TAF had improved renal safety as compared to TDF. TAF has been approved for treating CHB since 2017; however, it is still unknown whether the efficacy and renal safety of TAF is compatible to those of ETV. The investigators aim to conduct an open label, randomized controlled trial comparing TAF with ETV for assessing their efficacy and renal safety in CHB patients. The eligible CHB patients are randomly assigned (1:1) to receive TAF or ETV. After allocation to TAF group or ETV group, study subjects will receive therapy for 3 years (144 weeks).
Interventions
DRUGTenofovir alafenamide
Tenofovir alafenamide 25mg/tab once daily
DRUGEntecavir
Entecavir 0.5mg/tab once daily
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a study designed for non-inferior outcome comparisons for TAF and ETV. The eligible chronic hepatitis B patients are randomly assigned (1:1) to receive once-daily oral doses of TAF 25 mg or ETV 0.5mg.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients more than 20 years old 2. Chronic hepatitis B patients 3. Patients who were indicated for hepatitis B virus antiviral therapy
Exclusion criteria
1. Decompensated liver disease (Child-Pugh B \&C) 2. End stage renal disease (eGRF \< 15 ml/min/1.73m2) 3. Prior use of nucleot(s)ide analogues for chronic hepatitis B 4. Prior use of interferon for chronic hepatitis B within six months 5. Known history of human immunodeficiency virus or hepatitis C virus co-infection 6. Concurrent other uncontrolled malignancy 7. Women in pregnancy or lactation 8. Cannot conform to the study protocol of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBV viral suppression | After 48-week therapy of Tenofovir alafenamide or entecavir | proportion of patients with hepatitis B virus(HBV) -DNA suppression |
| Renal safety: Change of estimated glomerular filtration rate | After 48-week therapy of Tenofovir alafenamide or entecavir | Change of estimated glomerular filtration rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal safety: Change of estimated glomerular filtration rate | After 144-week therapy of Tenofovir alafenamide or entecavir | Change of estimated glomerular filtration rate |
| HBV viral suppression | After 144-week therapy of Tenofovir alafenamide or entecavir | proportion of patients with hepatitis B virus(HBV) -DNA suppression |
| Normalization alanine aminotransferase (ALT) | After 144-week therapy of Tenofovir alafenamide or entecavir | proportion of patients with ALT normalization |
| HBsAg loss | After 144-week therapy of Tenofovir alafenamide or entecavir | proportion of patients with HBsAg loss |
| Bone mineral density | After 144-week therapy of Tenofovir alafenamide or entecavir | change of bone mineral density |
Countries
Taiwan
Contacts
CONTACTTeng-Yu Lee, MD, PhD
CONTACTHsin-Ju Tsai, MD
STUDY_CHAIRTeng-Yu Lee, MD, PhD
Taichung Veterans General Hospital
Outcome results
None listed