Clinical trial NCT03933384: Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B
Official title: Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: an Open Label, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hepatitis B
Viral Hepatitis
Keywords: Hepatitis B
Viral Hepatitis
Tenofovir alafenamide
Entecavir
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: HBV viral suppression
timeFrame: After 48-week therapy of Tenofovir alafenamide or entecavir
measure: Renal safety: Change of estimated glomerular filtration rate
timeFrame: After 48-week therapy of Tenofovir alafenamide or entecavir
Secondary outcomes:
measure: Renal safety: Change of estimated glomerular filtration rate
timeFrame: After 144-week therapy of Tenofovir alafenamide or entecavir
measure: HBV viral suppression
timeFrame: After 144-week therapy of Tenofovir alafenamide or entecavir
measure: Normalization alanine aminotransferase (ALT)
timeFrame: After 144-week therapy of Tenofovir alafenamide or entecavir
measure: HBsAg loss
timeFrame: After 144-week therapy of Tenofovir alafenamide or entecavir
measure: Bone mineral density
timeFrame: After 144-week therapy of Tenofovir alafenamide or entecavir
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Teng-Yu Lee, MD, PhD
role: STUDY_CHAIR
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