摘要目的:评价并比较含整合酶抑制剂的单片制剂方案比克恩丙诺片(B/F/TAF)与拉米夫定多替拉韦片(3TC/DTG)用于初治艾滋病期患者的临床疗效及安全性。方法:本研究为一项回顾性队列研究，通过收集2020年10月至2023年7月在上海市(复旦大学附属)公共卫生临床中心使用B/F/TAF或3TC/DTG作为初始抗反转录病毒治疗方案且持续用药时间≥24周的艾滋病期患者的临床资料，比较B/F/TAF组与3TC/DTG组基线人类免疫缺陷病毒(HIV)-1 RNA，基线和治疗12周的CD4 ＋T淋巴细胞计数，治疗24周的病毒学抑制率和病毒学失败率，以及治疗前后总胆固醇、血肌酐、尿酸等指标变化。统计学分析采用独立样本 t检验、校正 t检验、曼-惠特尼 U检验、威尔科克森符号秩检验、 χ2检验。 结果:189例初治艾滋病期患者中，B/F/TAF组141例，3TC/DTG组48例。B/F/TAF组患者基线HIV-1 RNA为1.77(0.78，4.52)×10 5拷贝/mL，3TC/DTG组为0.97(0.24，2.20)×10 5拷贝/mL，差异有统计学意义( U＝2 221.00， P＝0.006)。B/F/TAF组治疗24周病毒学抑制率为77.3%(109/141)，无病毒学失败的患者；3TC/DTG组治疗24周病毒学抑制率为85.4%(41/48)，1例(2.1%)病毒学失败。治疗12周时，B/F/TAF组CD4 ＋T淋巴细胞计数较基线升高30%以上的患者占92.2%(130/141)，3TC/DTG组为85.4%(41/48)；B/F/TAF组CD4 ＋T淋巴细胞计数较基线升高>100.00/μL的比例为67.4%(95/141)，3TC/DTG组为52.1%(25/48)；两组间差异均无统计学意义( χ2＝1.91、3.61， P＝0.167、0.733)。B/F/TAF组和3TC/DTG组患者治疗24周时总胆固醇( W＝2 036.00, t＝－5.42)、血肌酐( W＝1 098.00、234.00)、尿酸( W＝2 188.00、299.00)水平均较治疗前升高，轻中度肾功能不全患者比例( χ2＝22.29、8.22)均较治疗前增加，差异均有统计学意义(均 P<0.01)。 结论:B/F/TAF与3TC/DTG用于初治艾滋病期患者具有良好的病毒学、免疫学疗效和安全性。

abstractsObjective:To analyze the efficacy and safety of integrase inhibitor-based single-tablet regimens bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and lamivudine/dolutegravir (3TC/DTG) in the treatment-na?ve patients with acquired immunodeficiency syndrome (AIDS).Methods:This study was a retrospective cohort study. The clinical data of treatment-na?ve AIDS patients initiating anti-retroviral therapy (ART) with B/F/TAF or 3TC/DTG and on ART for greater than or equal to 24 weeks from October 2020 to July 2023 in Shanghai Public Health Clinical Center, Fudan University were collected. The baseline human immunodeficiency virus (HIV)-1 RNA, CD4 + T lymphocyte counts at baseline and 12 weeks of treatment, and the rates of virological suppression and virological failure at 24 weeks of treatment, and levels of total cholesterol, serum creatinine, uric acid before and after treatment were compared between the B/F/TAF group and 3TC/DTG group. Independent sample t test, corrected t test, Mann-Whitney U test, Wilcoxon signed rank test, chi-square test were used for statistical analysis. Results:Among 189 treatment-na?ve AIDS patients, 141 cases were in B/F/TAF group and 48 cases in 3TC/DTG group. The HIV-1 RNA level at baseline was 1.77(0.78, 4.52)×10 5 copies/mL in the B/F/TAF group and 0.97(0.24, 2.20)×10 5 copies/mL in the 3TC/DTG group. There was a statistically significant difference between the two groups ( U=2 221.00, P=0.006).There were 77.3%(109/141) patients on B/F/TAF achieved complete virological suppression with no virological failure at week 24, and 85.4%(41/48) on 3TC/DTG achieved complete virological suppression with one (2.1%) virological failure at week 24. At 12 weeks of treatment, 92.2%(130/141) of the patients in the B/F/TAF group and 85.4%(41/48) of the patients in the 3TC/DTG group had an increase in CD4 + T lymphocyte count by more than 30% compared with baseline. The proportion of CD4 + T lymphocyte count increased by more than 100/μL from baseline in the B/F/TAF group was 67.4%(95/141), and that in the 3TC/DTG group was 52.1%(25/48). There were no significant differences between the two groups ( χ2=1.91 and 3.61, respectively, P=0.167 and 0.733).The levels of total cholesterol ( W=2 036.00, t=-5.42, respectively), serum creatinine ( W=1 098.00, 234.00, respectively), uric acid ( W=2 188.00, 299.00, respectively) and the proportion of patients with mild to moderate renal insufficiency ( χ2=22.29, 8.22, respectively) in the B/F/TAF group and 3TC/DTG group after 24 weeks of treatment were significantly higher than those before treatment (all P<0.01). Conclusions:Both B/F/TAF and 3TC/DTG are effective in terms of virological suppression and immunological recovery and have good safety profiles in treatment-na?ve patients with AIDS.