Tenofovir Amibufenamide Comparable to TDF in the Treatment of Chronic Hepatitis B

Chronic hepatitis B (CHB) persists as a global health challenge, with effective antiviral therapies needed to manage the condition long-term. Hepatitis B virus antiviral treatment may prevent or reverse disease progression, reduce the incidence of liver cancer, and even lower mortality associated with hepatitis B-related diseases. Authors of a study published in the Journal of Clinical and Transplantation Hepatology analyzed the antiviral effectiveness of tenofovir amibufenamide (Vemlidy; Gilead Sciences, Inc.) in the treatment of patients with CHB, providing a reference for the subsequent selection of antiviral therapy for these patients.

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The investigators enrolled patients with CHB who visited the Second Affiliated Hospital of Xi’an Jiaotong University, the Fourth People’s Hospital of Qinghai Province, 3201 Hospital Affiliated [with] Xi’an Jiaotong University, or the Infection Department at the Affiliated Hospital of Yan’an University between August 2021 and August 2022. Additional inclusion criteria included meeting the guidelines for the prevention and treatment of CHB; age 18 to 65, with no sex limitations; and receipt of prior treatment with entecavir (Baraclude; Bristol-Myers Squibb) or tenofovir disoproxil fumarate (TDF, Viread; Gilead Sciences, Inc.) for 96 weeks without achieving a complete virological response, showing early markers of renal function impairment, and who were switched to tenofovir amibufenamide treatment after providing consent.

Patients who were treatment-naïve and met the criteria for receiving 25 mg of once-daily tenofovir amibufenamide or 300 mg of once-daily TDF were enrolled in the study. Additionally, patients who had previously received treatment with entecavir (0.5 mg once daily) or TDF (300 mg once daily) antiviral therapy for a minimum of 96 weeks but experienced poor treatment efficacy or kidney safety issues were eligible to switch to tenofovir amibufenamide (25 mg once daily).

From treatment weeks 4 to 12, patients were visited once at 4 weeks and then once every 12 weeks thereafter. Adherence was evaluated every 12 weeks. Baseline data and laboratory evaluations of the patients were collected, including hematology analysis, serum chemistry tests, blood lipids, and renal function measurements (eg, serum creatinine concentrations, estimated glomerular filtration rate [eGFR], cystatin C, and early renal response). The primary end point was a complete virological response (HBV DNA concentrations < 20 IU/mL) and a change in the amount of HBV DNA (log IU/mL) at 24 and 48 weeks. Secondary end points included changes in the alanine transaminase (ALT) normalization rate, serology (HBsAg and hepatitis B e antigen [HBeAg] negative conversion rates and HBsAg and HBeAg seroconversion rates), renal function, and blood lipid values.

A total of 194 patients with CHB were recruited and divided into treatment-naïve (n = 123) and treatment-experienced (n = 71) groups. The treatment-naïve group was further subdivided into tenofovir amibufenamide (n = 63) and TDF (n = 60) subgroups.

The findings demonstrated that in the treatment-naïve cohort, 24- and 48-week virological response rates were approximately 42.86% and 90.48%, respectively, for tenofovir amibufenamide and 60.00% and 83.33% for TDF. Additionally, ALT normalization rates at 24 and 48 weeks for tenofovir amibufenamide were approximately 56.82% and 70.45%. For patients who previously received treatment, virological response rates at 24 and 48 weeks were approximately 83.1% and 91.55%, respectively, and ALT normalization rates were 86.67% and 93.33% (local standards), and 66.67% and 76.67% (American Association for the Study of Liver Diseases 2018 standards; z = −2.822, P = .005). Tenofovir amibufenamide also demonstrated an improvement in renal safety compared with TDF, with no significant differences in lipid concentrations.

The authors noted that the 48-week follow-up period may not have been sufficient to properly evaluate the antiviral effect; therefore, a longer follow-up could have a different impact on the antiviral effectiveness results. Additionally, the authors note that the study lacks information on bone metabolism biomarkers such as bone turnover markers and dual-energy X-ray absorptiometry because of the high cost and scope limitations.

REFERENCE

Li Y, Lin Y, Gou G, et al. Effectiveness and Safety of Tenofovir Amibufenamide in the Treatment of Chronic Hepatitis B: A Real-world, Multicenter Study. J Clin Transl Hepatol. Published online: Jan 2, 2025. doi:10.14218/JCTH.2024.00364.