The study evaluates the effectiveness and safety of TMF for chronic hepatitis B

The study evaluates the effectiveness and safety of TMF for chronic hepatitis B

Background and goals

Chronic hepatitis B (CHB) remains a significant global health challenge, and effective antiviral therapies are essential for long-term management. This study aimed to evaluate the efficacy and safety of tenofovir-amibutenamide (TMF) in a cohort of patients with chronic hepatitis B (CHB).

Methods

In this multicenter, prospective, real-world cohort study of 194 CHBs were recruited from four hospitals between August 2021 and August 2022. Patients were divided into treatment-naïve (tn, n = 123) and treatment-aware (TE, n = 71) groups. The TN group was further divided into TMF (n = 63) and tenofovir disoproxil fumarate (TDF, n = 60) subgroups. In the TE group, patients crossed over to TMF after prior antiviral therapies (Endecavir or TDF) after meeting criteria for poor virologic response or safety concerns. Treatment response was assessed by virologic efficacy and alanine transaminase normalization rates. Virological response (VR), ALT normalization rates, renal function markers and lipid profiles were monitored.

Results

In the TN cohort, VR rates at 24 and 48 weeks were 42.86% and 90.48% for TMF and 60.00% and 83.33% for TDF. The ALT normalization rates at 24 and 48 weeks for TMF were 56.82% and 70.45% (according to AASLD 2018 standards). In the TE group, the VR rates at 24 and 48 weeks were 83.1% and 91.55%, respectively. The Alt normalization rates were 86.67% and 93.33% (local standards) and 66.67% and 76.67% (AASLD 2018 standards) (Z = −2.822,P= 0.005). Additionally, TMF demonstrated improved renal safety over TDF, with no significant differences in lipid concentrations.

Conclusions

TMF is comparable to TDF in CHB treatment effectiveness, with better renal safety and no effects on lipid levels. In TE patients, transition to TMF therapy does not affect antiviral treatment outcomes.

Sources: