Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    420
  • sponsor
    Taichung Veterans General Hospital
Updated on 26 March 2022
tenofovir
hepatitis
antiviral therapy
entecavir
antiviral agents

Summary

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

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).

Details
Condition Hepatitis B, Viral Hepatitis
Treatment Entecavir, Tenofovir alafenamide
Clinical Study IdentifierNCT03933384
SponsorTaichung Veterans General Hospital
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients more than 20 years old
Chronic hepatitis B patients
Patients who were indicated for hepatitis B virus antiviral therapy

Exclusion Criteria

Decompensated liver disease (Child-Pugh B &C)
End stage renal disease (eGRF < 15 ml/min/1.73m2)
Prior use of nucleot(s)ide analogues for chronic hepatitis B
Prior use of interferon for chronic hepatitis B within six months
Known history of human immunodeficiency virus or hepatitis C virus co-infection
Concurrent other uncontrolled malignancy
Women in pregnancy or lactation
Cannot conform to the study protocol of this study
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