Li-Li Liu, Yi Feng, Chao-Yi Ren, Yi Liu, Ming-Hui Zhu, Guo-Xiang Hao, Tian-Tian Gao
{"title":"替诺福韦氨布芬胺和替诺福韦阿拉那胺在48周慢性乙型肝炎治疗中的实际药理学评估：疗效、安全性和成本效益。","authors":"Li-Li Liu, Yi Feng, Chao-Yi Ren, Yi Liu, Ming-Hui Zhu, Guo-Xiang Hao, Tian-Tian Gao","doi":"10.1007/s11596-025-00120-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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/%).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":10820,"journal":{"name":"Current Medical Science","volume":" ","pages":""},"PeriodicalIF":1.5000,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A Real-World Pharmacological Assessment of Tenofovir Amibufenamide and Tenofovir Alafenamide in 48-Week Chronic Hepatitis B Treatment: Efficacy, Safety, and Cost-Effectiveness.\",\"authors\":\"Li-Li Liu, Yi Feng, Chao-Yi Ren, Yi Liu, Ming-Hui Zhu, Guo-Xiang Hao, Tian-Tian Gao\",\"doi\":\"10.1007/s11596-025-00120-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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/%).</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":10820,\"journal\":{\"name\":\"Current Medical Science\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":1.5000,\"publicationDate\":\"2025-10-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Current Medical Science\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s11596-025-00120-5\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current Medical Science","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s11596-025-00120-5","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
A Real-World Pharmacological Assessment of Tenofovir Amibufenamide and Tenofovir Alafenamide in 48-Week Chronic Hepatitis B Treatment: Efficacy, Safety, and Cost-Effectiveness.
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.
期刊介绍：
Current Medical Science provides a forum for peer-reviewed papers in the medical sciences, to promote academic exchange between Chinese researchers and doctors and their foreign counterparts. The journal covers the subjects of biomedicine such as physiology, biochemistry, molecular biology, pharmacology, pathology and pathophysiology, etc., and clinical research, such as surgery, internal medicine, obstetrics and gynecology, pediatrics and otorhinolaryngology etc. The articles appearing in Current Medical Science are mainly in English, with a very small number of its papers in German, to pay tribute to its German founder. This journal is the only medical periodical in Western languages sponsored by an educational institution located in the central part of China.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
