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

Phase 4

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Tenofovir alafenamide(TAF); Drug: Tenofovir disoproxil fumarate(TDF)

• Registration Number: NCT03356834
• Lead Sponsor: Humanity and Health Research Centre

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-11-24
• Study First Posted: 2017-11-29
• Study Start: 2017-12-01
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 575

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TDF switch to TAF	Tenofovir alafenamide(TAF)	Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Tenofovir Alafenamide(TAF) 25mg daily
Maintaining on TDF	Tenofovir disoproxil fumarate(TDF)	Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily

Primary Outcome Measures

Name	Time	Method
Antiviral response of TAF	60 months	Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients

Secondary Outcome Measures

Name	Time	Method
Improvement of renal function and bone mineral density in CHB patients switching to TAF	60 months	Change of renal function and bone mineral density from baseline in CHB patients of TAF a group compared with TDF group

Trial Locations

Locations (1)

Humanity and Health GI and Liver Centre; 🇭🇰 Hong Kong, Hong Kong