BIC/FTC/TAF 单片方案真实世界临床疗效和安全性研究. (Chinese)

Real-World Clinical Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide （BIC/FTC/TAF） Single-Tablet Regimen. (English)

Objective To analyze the efficacy and safety of the three-in-one single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide（BIC/FTC/TAF） in AIDS patients. Methods Newly treated patients who received a single tablet combination（BIC/FTC/TAF） between February 1，2022 and June 1，2022（the initial treatment group） and those who underwent treatment（ the treated group） were included. The virological， immunological and biochemical indexes were statistically analyzed by means of prospective observational study. Results 249 patients were included at baseline, with 220 in the treated group and 29 in the newly treated group. At 48 weeks， the analysis showed that the virus suppression rate was 93.10% for the newly treated group and 98.55% for the treated group. Compared to the baseline, both groups showed increased CD4⁺ T lymphocyte counts and CD4⁺ /CD8⁺ T cell ratios after 48 weeks of treatment（P < 0.001）. There were also significant increases in blood triglycerides, total cholesterol, total bilirubin, and blood creatinine compared to the baseline（P < 0.05）. Aspartate aminotransferase and alanine aminotransferase decreased compared to the baseline， with all differences being statistically significant except for alanine aminotransferase in the newly treated group（P > 0.05）. Additionally，the estimated glomerular filtration rate based on blood creatinine improved in the newly treated group compared to the baseline（P < 0.001），while there were no significant changes in the treated group. Conclusion BIC/FTC/TAF can effectively inhibit virus replication，improve the immune function of patients, and has good safety. Bic /FTC/TAF can be one of the preferred treatment options for some specific clinical populations. [ABSTRACT FROM AUTHOR]

目的 分 析 比 克 替 拉 韦/ 恩 曲 他 滨/ 丙 酚 替 诺 福 韦（ bictegravir/emtricitabine/tenofovir alafenamide， BIC/FTC/TAF）三合一单片复方制剂在艾滋病抗病毒治疗患者中的疗效和安全性。方法 纳入 2022 年 2 月 1 日 至 2022 年 6 月 1 日期间接受单片复方制剂 （BIC/FTC/TAF） 的初治患者（初治组）和经历过治疗的患者（经治组）， 并使用前瞻性观察研究的方法对其治疗后的病毒学、免疫学和生化学指标进行了统计分析。结果 基线共纳入 了 249 名患者，其中经治组 220 例，初治组 29 例。48 周时符合方案分析结果显示，初治组病毒完全抑制率为 93.10%，经治组为 98.55%。与基线相比，2 组患者治疗 48 周后的 CD4^＋T 淋巴细胞计数和 CD4⁺/CD8^＋T 细胞比 值均升高（P < 0.001），血甘油三酯、总胆固醇、总胆红素和血肌酐较基线相比也有所升高，且差异具有统计学 意义（P < 0.05），门冬氨酸氨基转移酶和丙氨酸氨基转移酶较基线相比均有所降低，除了初治组丙氨酸氨基转移 酶（P > 0.05），其余 3 个差异均有统计学意义（P < 0.05），而基于血肌酐估算的肾小球滤过率，初治组较基线有 所改善（P < 0.001），经治组无明显改变。结论 BIC/FTC/TAF 不论对初治患者还是经治患者均能有效抑制病毒 的复制，提高患者的免疫能力，安全性也较好，是可以成为临床某些特定人群的首选治疗方案之一。 [ABSTRACT FROM AUTHOR]

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