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Efficacy and safety of tenofovir amibufenamide vs. tenofovir disoproxil fumarate for chronic hepatitis B

Efficacy and safety of tenofovir amibufenamide vs. tenofovir disoproxil fumarate for chronic hepatitis B Efficacy and safety of tenofovir amibufenamide vs. tenofovir disoproxil fumarate for chronic hepatitis B
Efficacy and safety of tenofovir amibufenamide vs. tenofovir disoproxil fumarate for chronic hepatitis B Efficacy and safety of tenofovir amibufenamide vs. tenofovir disoproxil fumarate for chronic hepatitis B

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.

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Key take away

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.

Background

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.

Method

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.

Result

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.

Conclusion

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

Source:

Alimentary Pharmacology & Therapeutics

Article:

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

Authors:

Zhihong Liu et al.

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