Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF

  • STATUS
    Recruiting
  • End date
    Oct 8, 2023
  • participants needed
    1000
  • sponsor
    Humanity and Health Research Centre
Updated on 8 September 2021
tenofovir
hepatitis
fumarate
antiviral drugs
chronic hepatitis

Summary

In Chronic hepatitis B (CHB) patients receiving long-term sequential Neucleos(t)ides(NAs), majority of these CHB patients experienced drug resistance and switched to Tenofovir disoproxil fumaratate(TDF). However, some of patients on long term TDF experienced impairment of renal function and bone mineral density. After Tenofovir alafenamide(TAF) was in clinical practice, these group of patients got an clinical option to switch from TDF to TAF. The investigators designed a prospective cohort study to evaluate the real life effectiveness and safety in participants with chronic HBV infection switch from TDF to TAF vs. maintaining on TDF.

Description

Tenofovir disoproxil fumarate(TDF) have been associated with renal toxicity and reduced bone mineral density. Tenofovir alafenamide(TAF) is a novel tenofovir prodrug that reduces tenofovir plasma concentrations by 90%, thereby decreasing off-target side-effects. The investigators aimed to assess whether efficacy, safety, and tolerability were non-inferior in participants switched to TAF versus in those remaining on TDF. This is a prospective clinical study.

Details
Condition chronic hepatitis b, Hepatitis B
Treatment Tenofovir alafenamide(TAF), Tenofovir disoproxil fumarate(TDF)
Clinical Study IdentifierNCT03356834
SponsorHumanity and Health Research Centre
Last Modified on8 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Chronic hepatitis B
Antiviral experienced
Currently on long term TDF anti-HBV treatment
HBV DNA < 6 log IU/ml (LLOD)
Able to sign the consent form of anticipating in the study

Exclusion Criteria

Co-infected with HCV, HIV or other viral hepatitis
Diagnosis of HCC
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