Change of Renal Function and Bone Mineral Density Marker in Chronic Hepatitis B Patients Switching from TDF to TAF Vs. Maintaining TDF
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 575
- Locations
- 1
- Primary Endpoint
- Antiviral response of TAF
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
TDF switch to TAF
Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Tenofovir Alafenamide(TAF) 25mg daily
Intervention: Tenofovir alafenamide(TAF) (Drug)
Maintaining on TDF
Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily
Intervention: Tenofovir disoproxil fumarate(TDF) (Drug)
Outcomes
Primary Outcomes
Antiviral response of TAF
Time Frame: 60 months
Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients
Secondary Outcomes
- Improvement of renal function and bone mineral density in CHB patients switching to TAF(60 months)
Investigators
George Lau
Humanity & Healthy Medical Group President
Humanity and Health Research Centre