Efficacy and Safety of TAF in Patients With Suboptimal Response to Other Nucleos(t)Ides
Status:
Recruiting
Trial end date:
2023-09-30
Target enrollment:
Participant gender:
Summary
Both tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) are potent antiviral
agents for hepatitis B virus (HBV) and recommended by the American Association for the Study
of Liver Disease (AASLD) as well as the European Association for the Study of Liver (EASL)
guidelines for the treatment of nucleos(t)ide therapy induced HBV resistance. However, it is
not clear if chronic hepatitis B (CHB) patients with nucleos(t)ide treatment experience
without genotypic mutations would be benefit from TAF therapy. Previous studies have observed
that suboptimal response (SOR) following antiviral therapy with nucleos(t)ide treatment is
associated with an increased risk of subsequent treatment failure and viral resistance. It
remains unclear whether switching to TAF is a reasonable approach in patients with SOR to
second-line antivirals Lamivudine (LAM)/ Telbivudine (LdT)/ Adefovir Dipivoxil (ADV) and its
combinations with other second-line antivirals for 24 weeks, or SOR to the first-line
antiviral Entecavir (ETV) or any antiviral combinations containing ETV for 48 weeks. This
study is aimed to determine how the aforementioned patients with SOR to nucleos(t)ide
treatment respond to TAF monotherapy. The investigator's study will provide evidence base for
therapy selection in SOR patients, especially in China where the majority of patients with
CHB are treated with nucleos(t)ide therapy.