Current medical science · 2025
A Real-World Pharmacological Assessment of Tenofovir Amibufenamide and Tenofovir Alafenamide in 48-Week Chronic Hepatitis B Treatment: Efficacy, Safety, and Cost-Effectiveness.
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Liu Li-Li, Feng Yi, Ren Chao-Yi, Liu Yi, Zhu Ming-Hui, Hao Guo-Xiang, Gao Tian-Tian
Аннотация
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.
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.