替诺福韦-阿米布非那胺与替诺福韦-阿拉非那胺在高病毒载量慢性乙型肝炎初始 48 周治疗中的疗效和安全性比较：单中心回顾性研究。

IF 1.3 4区医学 Q4 INFECTIOUS DISEASES

Antiviral Therapy Pub Date : 2024-10-01 DOI:10.1177/13596535241284226

Qing Zhang,Jianhua Xu,Dan Liu,Lilin Wang,Shan Ren,Sujun Zheng,Xinyue Chen,Li Qi,Junfeng Lu

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引用次数: 0

摘要

背景/目的替诺福韦-阿米布非那胺（TMF）采用创新的 ProTide 技术和甲基化策略来提高酰胺键的脂溶性和血浆稳定性，与替诺福韦-阿拉非那胺（TAF）相比更具优势。尽管 III 期临床试验结果表明 TMF 具有良好的抗病毒疗效，但有关 TMF 的实际数据仍然很少。方法我们回顾性地收集了2022年3月1日至2022年6月30日期间北京佑安医院接受TMF（58例）或TAF（32例）作为初始单药治疗的高病毒载量CHB患者的临床数据。为了解 48 周内 TMF 的疗效和安全性，我们比较了 TMF 组和 TAF 组的病毒学应答率和 HBeAg/HBsAg 血清学清除率。结果 TMF 和 TAF 的基线 HBV DNA 中位水平分别为 7.85 (6.89, 8.36) IgIU/ml和 7.44 (6.89, 8.03) IgIU/ml。TMF和TAF的ALT水平中位数分别为102.0（56.0，210.0）U/L和195.0（73.5，371.0）U/L，HBeAg阳性率分别为70.7%和75.0%。48周时，TMF的病毒学应答率（HBV DNA <10 IU/ml）为43.5%（20/46），TAF为42.9%（12/28）（p = 1.000）。TMF和TAF的ALT正常化率分别为87.9%和90.6%（p = .969），HBeAg血清学清除率分别为21.1%和18.2%（p = 1.000）。没有患者达到 HBsAg 清除率。与基线相比，TMF 组和 TAF 组的低密度脂蛋白胆固醇（LDL-C）水平升高，而 eGFR 下降，但在第 48 周时，血清肌酐、甘油三酯和总胆固醇水平无显著差异。

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Comparative efficacy and safety of tenofovir amibufenamide vs tenofovir alafenamide in the initial 48-week treatment of high viral load chronic hepatitis B: A single-centre retrospective study.

BACKGROUND/AIM Tenofovir amibufenamide (TMF) employs innovative ProTide technology and a methylation strategy to enhance the lipid solubility and plasma stability of the amide bond, providing advantages over tenofovir alafenamide (TAF). Despite promising Phase III clinical trial results demonstrating its antiviral efficacy, real-world data on TMF remains scarce. This study evaluates the antiviral efficacy and safety of TMF compared to TAF as the initial treatment in patients with high viral loads of chronic hepatitis B (CHB). METHODS We retrospectively collected clinical data from March 1 2022 to June 30 2022 for highly viremic CHB patients who received either TMF (n = 58) or TAF (n = 32) as their initial monotherapy at Beijing YouAn Hospital. To understand the efficacy and safety of TMF over 48 weeks, we compared the virological response rates and HBeAg/HBsAg serological clearance rates between TMF and TAF groups. Also, the changes in serum creatinine, eGFR and serum lipid levels were assessed. RESULTS Baseline median HBV DNA levels were 7.85 (6.89, 8.36) IgIU/ml for TMF and 7.44 (6.89, 8.03) IgIU/ml for TAF. Median ALT levels were 102.0 (56.0, 210.0) U/L for TMF and 195.0 (73.5, 371.0) U/L for TAF, with HBeAg positivity rates of 70.7% and 75.0%, respectively. At 48 weeks, virological response rates (HBV DNA <10 IU/ml) were 43.5% (20/46) for TMF and 42.9% (12/28) for TAF (p = 1.000). ALT normalization rates were 87.9% for TMF and 90.6% for TAF (p = .969), and HBeAg serological clearance rates were 21.1% and 18.2%, respectively (p = 1.000). No patients achieved HBsAg clearance. Compared with the baseline, LDL-C levels increased, while eGFR decreased, with no significant differences in serum creatinine, triglycerides and total cholesterol levels noted at week 48 for both TMF and TAF groups. CONCLUSION TMF demonstrates comparable antiviral efficacy to TAF when used as initial therapy in highly viremic CHB patients, with similar impacts on renal function and lipid profiles.

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来源期刊

Antiviral Therapy 医学-病毒学

CiteScore

2.60

自引率

8.30%

发文量

审稿时长

4-8 weeks

期刊介绍： Antiviral Therapy (an official publication of the International Society of Antiviral Research) is an international, peer-reviewed journal devoted to publishing articles on the clinical development and use of antiviral agents and vaccines, and the treatment of all viral diseases. Antiviral Therapy is one of the leading journals in virology and infectious diseases. The journal is comprehensive, and publishes articles concerning all clinical aspects of antiviral therapy. It features editorials, original research papers, specially commissioned review articles, letters and book reviews. The journal is aimed at physicians and specialists interested in clinical and basic research.