Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

Taichung Veterans General Hospital

Status and phase: Enrolling; Phase 4

Conditions: Hepatitis B; Viral Hepatitis

Treatments: Drug: Tenofovir alafenamide; Drug: Entecavir

Study type: Interventional

Funder types: Other

Identifiers

NCT03933384

CF18341A

106DHA0500150 (Other Grant/Funding Number)

Details and patient eligibility

About

To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.

Full 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).

Enrollment: 140 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 2 patient groups

Tenofovir alafenamide group

Active Comparator group

Description:

Study subjects will receive tenofovir alafenamide 25 mg/tab once daily

Treatment:

Drug: Tenofovir alafenamide

Entecavir group

Active Comparator group

Description:

Study subjects will receive entecavir 0.5 mg/tab once daily

Treatment:

Drug: Entecavir