Tenofovir amibufenamide demonstrated effectiveness comparable to tenofovir disoproxil fumarate in the treatment of chronic hepatitis B, with improved renal safety and no impact on lipid profiles, according to a real-world, multicenter cohort study.

In the prospective study, published in the Journal of Clinical and Translational Hepatology, researchers evaluated 194 patients with chronic hepatitis B (CHB) across four hospitals between August 2021 and August 2022. The patients were grouped into treatment-naive (TN; n = 123) and treatment-experienced (TE; n = 71) cohorts. The TN cohort was further divided into tenofovir amibufenamide (TMF) (n = 63) and tenofovir disoproxil fumarate (TDF) (n = 60) subgroups. Treatment responses were assessed on the basis of virologic response (VR), alanine transaminase (ALT) normalization rates, renal function markers, and lipid levels.

In the TN group, VR rates for TMF were 42.86% at 24 weeks and 90.48% at 48 weeks, whereas TDF showed VR rates of 60.00% and 83.33%, respectively. ALT normalization rates for TMF in the TN cohort were 56.82% and 70.45% at 24 and 48 weeks, respectively, based on 2018 American Association for the Study of Liver Diseases (AASLD) standards.

Among TE patients transitioning from entecavir or TDF as a result of poor VR or safety concerns, TMF achieved VR rates of 83.1% at 24 weeks and 91.55% at 48 weeks. ALT normalization rates in the TE cohort were 86.67% at 24 weeks and 93.33% at 48 weeks (local standards) and 66.67% and 76.67% (2018 AASLD standards). Statistical analysis revealed statistically significant differences in ALT normalization between local and AASLD 2018 standards (z = −2.822, P = .005).

TMF also exhibited improved renal safety compared with TDF, with no statistically significant differences in lipid concentrations between the two drugs.

"TMF is comparable to TDF in terms of CHB treatment effectiveness, with better renal safety and no impact on lipid levels. In TE patients, transitioning to TMF therapy does not affect antiviral treatment outcomes," said lead study author Yaping Li, of Xi’an Jiaotong University Second Affiliated Hospital in Xi’an, China, and colleagues.

This study highlighted the potential of TMF as a viable therapeutic alternative to TDF for long-term management of CHB, addressing both efficacy and safety concerns.

The authors have no conflicts of interest related to this publication.