Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

Phase 4

Recruiting

• Conditions: Hepatitis B; Viral Hepatitis
• Interventions: Drug: Tenofovir alafenamide; Drug: Entecavir

• Registration Number: NCT03933384
• Lead Sponsor: Taichung Veterans General Hospital

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).

Study Timeline

• Study First Submitted: 2019-04-28
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-01
• Study Start: 2019-08-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2027-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir alafenamide group	Tenofovir alafenamide	Study subjects will receive tenofovir alafenamide 25 mg/tab once daily
Entecavir group	Entecavir	Study subjects will receive entecavir 0.5 mg/tab once daily

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan