A Real-World Pharmacological Assessment of Tenofovir Amibufenamide and Tenofovir Alafenamide in 48-Week Chronic Hepatitis B Treatment: Efficacy, Safety, and Cost-Effectiveness

Abstract

Objective

Chronic hepatitis B (CHB), characterized by a significant global disease burden and substantial healthcare costs, remains a critical public health challenge. Although tenofovir amibufenamide (TMF) and tenofovir alafenamide (TAF), including formulations from centralized volume-based procurement (CVBP-TAF) and imported sources (I-TAF), are all recommended treatment regimens, comparative studies on the efficacy, safety, and cost-effectiveness of these three regimens remain relatively limited. This retrospective cohort study aims to systematically compare the application effects of these three regimens in the treatment of CHB.

Methods

We conducted a single-center retrospective cohort study at Tianjin University Central Hospital from September 2019 to September 2024. CHB patients who had received TMF, CVBP-TAF, or I-TAF for 48 weeks were enrolled. Efficacy endpoints included HBV-DNA negative conversion, HBeAg seroclearance, and alanine aminotransferase (ALT) normalization. Safety outcomes encompassed nephrotoxicity, hepatotoxicity, and lipid profile changes. Cost-effectiveness analysis was used to calculate the cost-effectiveness ratio (CER) per unit efficacy gain and incremental CER using a healthcare payer perspective.

Results

A total of 173 patients were included, with 58 in the TMF group, 58 in the I-TAF group, and 57 in the CVBP-TAF group. TMF demonstrated superior efficacy to I-TAF and CVBP-TAF, as evidenced by significantly higher HBV-DNA negative conversion rate and ALT normalization rate. No significant differences in safety outcomes were observed among the three groups. Cost-effectiveness analysis showed that CVBP-TAF had the lowest CER (4.62 CNY/%), followed by TMF with an intermediate CER (60.45 CNY/%), while I-TAF had the highest CER (66.49 CNY/%).

Conclusion

TMF demonstrates stronger antiviral efficacy than both TAF formulations, with comparable safety profiles. Despite the cost advantages of CVBP-TAF resulting from procurement policies, the clinical benefits of TMF support its use. Future strategies should improve the affordability of TMF to expand its accessibility.

Keywords

Hepatitis B treatment / Clinical pharmacology / Efficacy / Cost-effectiveness analysis

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Funding

2024 Tianjin Comprehensive Clinical Evaluation of Drugs Project(TZH-2024-002)

Pilot study on the standardization of comprehensive clinical evaluation of drugs(PJC202410)

2023 Tianjin Pharmacy Young and Middle-aged Research Programs(TJYX2023-03)

RIGHTS & PERMISSIONS

The Author(s), under exclusive licence to the Huazhong University of Science and Technology