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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.
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.
Alimentary Pharmacology & Therapeutics
Randomised clinical trial: 48 weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B
Zhihong Liu et al.
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