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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03356834

Acronym

SWITAF

Enrollment

575

Registered

2017-11-29

Start date

2017-12-01

Completion date

2024-10-31

Last updated

2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis B, Efficacy, safety, and tolerability, Tenofovir alafenamide

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.

Interventions

DRUGTenofovir alafenamide(TAF)

25 mg tablet administered orally once daily

DRUGTenofovir disoproxil fumarate(TDF)

300 mg tablet administered orally once daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026