Tenofovir Amibufenamide Shows Efficacy In Chronic Hepatitis B Patients With Normal Alt

3 weeks ago

Background and aims

Chronic hepatitis B microorganism (HBV)-infected patients whitethorn grounds liver fibrosis and different pathological changes contempt normal alanine aminotransferase (ALT). This study aimed to measure nan efficacy and information of tenofovir amibufenamide (TMF) successful chronic HBV-infected patients pinch normal ALT levels.

Methods

The ongoing PROMOTE study (NCT05797714) is nan first prospective, multicenter, randomized, open-label, blank-controlled objective proceedings involving chronic HBV-infected patients pinch normal ALT levels. Participants were randomized successful a 1:1 ratio to person either TMF (TMF group) aliases nary curen (blank power group). The superior efficacy endpoint was nan proportionality of participants achieving HBV DNA levels <20 IU/mL astatine 48 weeks.

Results

A full of 197 participants were enrolled, pinch 95 successful nan TMF group and 102 successful nan blank power group. At 48 weeks, a importantly greater proportionality of participants successful nan TMF group achieved HBV DNA levels <20 IU/mL compared pinch nan power group (74.2% vs. 9.0%, P < 0.001). The TMF group demonstrated much pronounced reductions successful HBV DNA (−2.63 vs. −0.22 log10 IU/mL, P < 0.001), HBsAg (−0.07 vs. −0.04 log10 IU/mL, P = 0.02), and ALT levels (−14.09% vs. 0%, P = 0.003) compared pinch nan blank control. In nan TMF group, nan proportionality of participants pinch high-normal ALT levels (20–40 IU/L) was reduced. No important differences were observed betwixt nan groups successful creatinine, glomerular filtration rate, bony turnover biomarkers, lipid profiles, aliases phosphorus levels.

Conclusions

TMF curen demonstrates important efficacy successful chronic HBV-infected patients pinch normal ALT levels and shows a favorable information floor plan regarding bone, renal, and lipid parameters. The PROMOTE study is ongoing, and further results astatine 96 and 144 weeks are expected to supply further insights.

Source:

Journal reference:

Gui, H., et al. (2025). Interim Analysis of 48-week Tenofovir Amibufenamide Treatment successful Chronic Hepatitis B Patients pinch Normal Alanine Aminotransferase Levels: The PROMOTE Study. Journal of Clinical and Translational Hepatology. doi.org/10.14218/jcth.2025.00162.

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