Randomised clinical trial: 48 weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B.

ABSTRACT:

Background

Tenofovir amibufenamide (TMF) can provide more efficient delivery than tenofovir disoproxil fumarate (TDF).

Aim

To compare the efficacy and safety of TMF and TDF for 48 weeks in patients with chronic hepatitis B (CHB).

Methods

We performed a randomised, double-blind, non-inferiority study at 49 sites in China. Patients with CHB were assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo. The primary efficacy endpoint was the proportion of patients with hepatitis B virus (HBV) DNA less than 20 IU/mL at week 48. We also assessed safety, particularly bone, renal and metabolic abnormalities.

Results

We randomised 1002 eligible patients. The baseline characteristics were well balanced between groups. After a median 48 weeks of trea

SUBMITTER: Liu Z 

PROVIDER: S-EPMC9292801 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature