A 48 weeks of treatment with tenofovir amibufenamide was non-inferior to tenofovir disoproxil fumarate in terms of anti-hepatitis B virus efficacy and demonstrated improved bone and renal safety.

A randomized clinical trial was performed to examine the efficacy and safety of tenofovir amibufenamide (TMF) and tenofovir disoproxil fumarate (TDF) for forty-eight weeks in individuals suffering from chronic hepatitis B.

In this double-blind, non-inferiority study, 1002 people with chronic hepatitis B were allocated to receive either 25 mg TMF or 300 mg TDF with a matching placebo. The percentage of people with hepatitis B virus DNA less than 20 IU/mL at week forty-eight was the major outcome ascertained. Assessment of safety (bone, renal and metabolic abnormalities) was also done.

The baseline characteristics were well balanced between the groups. Following a median forty-eight weeks of therapy, the non-inferiority criterion was fulfilled in all the analysis sets. In the HBeAg-positive and HBeAg-negative population, the percentage of people who attained hepatitis B virus  DNA less than 20 IU/mL in the TMF and TDF groups, is illustrated in Table 1:

The TMF group exhibited considerably less reduction in bone mineral density at both spine and hip, and a smaller rise in serum creatinine at week forty-eight. The other safety findings were similar between the groups.

Regarding anti-hepatitis B virus efficacy, TMF exhibited non-inferiority to TDF.