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

Study Overview
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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.

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.

Official Title
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Change of Renal Function and Bone Mineral Density Marker in Chronic Hepatitis B Patients Switching From TDF to TAF vs. Maintaining TDF

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Tenofovir alafenamide(TAF)
* Drug: Tenofovir disoproxil fumarate(TDF)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TDF switch to TAF<br>Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Tenofovir Alafenamide(TAF) 25mg daily | Drug: Tenofovir alafenamide(TAF)<br>* 25 mg tablet administered orally once daily<br>* Other names: VEMLIDY®;|
| Active Comparator: Maintaining on TDF<br>Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily | Drug: Tenofovir disoproxil fumarate(TDF)<br>* 300 mg tablet administered orally once daily<br>* Other names: VIREAD®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiviral response of TAF | Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of renal function and bone mineral density in CHB patients switching to TAF | Change of renal function and bone mineral density from baseline in CHB patients of TAF a group compared with TDF group | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis B, Efficacy, safety, and tolerability, Tenofovir alafenamide