Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

Last updated: January 7, 2025
Sponsor: Taichung Veterans General Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Hepatitis

Liver Disease

Hepatitis B

Treatment

Tenofovir alafenamide

Entecavir

Clinical Study ID

NCT03933384
CF18341A
106DHA0500150
  • Ages > 20
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Tenofovir alafenamide
Phase: 4
Study Start date:
August 19, 2019
Estimated Completion Date:
December 31, 2030

Study 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).

Connect with a study center

  • Taichung Veterans General Hospital

    Taichung,
    Taiwan

    Active - Recruiting

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