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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
575
25 mg tablet administered orally once daily
300 mg tablet administered orally once daily
Humanity and Health GI and Liver Centre
Hong Kong, Hong Kong, Hong Kong
Antiviral response of TAF
Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients
Time frame: 60 months
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
Time frame: 60 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.