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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

575 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2024-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TDF switch to TAF

Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Tenofovir Alafenamide(TAF) 25mg daily

Group Type EXPERIMENTAL

Tenofovir alafenamide(TAF)

Intervention Type DRUG

25 mg tablet administered orally once daily

Maintaining on TDF

Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily

Group Type ACTIVE_COMPARATOR

Tenofovir disoproxil fumarate(TDF)

Intervention Type DRUG

300 mg tablet administered orally once daily

Interventions

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Tenofovir alafenamide(TAF)

25 mg tablet administered orally once daily

Intervention Type DRUG

Tenofovir disoproxil fumarate(TDF)

300 mg tablet administered orally once daily

Intervention Type DRUG

Other Intervention Names

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VEMLIDY® VIREAD®

Eligibility Criteria

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Inclusion Criteria

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