Maggiolo Franco, Rizzardini Giuliano, Molina Jean-Michel, Pulido Federico, De Wit Stephane, Vandekerckhove Linos, Berenguer Juan, D'Antoni Michelle L, Blair Christiana, Chuck Susan K, Piontkowsky David, Martin Hal, Haubrich Richard, McNicholl Ian R, Gallant Joel
Division of Infectious Diseases, ASST Papa Giovanni XXIII, Bergamo, Italy.
Division of Infectious Diseases, Luigi Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy.
Infect Dis Ther. 2021 Jun;10(2):775-788. doi: 10.1007/s40121-021-00419-5. Epub 2021 Mar 9.
We report the 48-week results of an ongoing study to assess the efficacy and safety of switching older people with HIV to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF).
This was a 96-week, phase 3b, open-label, single-arm study (GS-US-380-4449; NCT03405935). Virologically suppressed individuals aged ≥ 65 years receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or a tenofovir disoproxil fumarate-based regimen were switched to B/F/TAF. Primary endpoint was the percentage of participants with HIV-1 RNA < 50 copies/ml at week 24.
Eighty-six participants (median age 69 [range 65-80] years; 87% male; 95% white) were enrolled and treated in five European countries. Rates of virologic suppression were 97.7% at week 24 and 90.7% at week 48; none had HIV-1 RNA ≥ 50 copies/ml, and 100% had virologic suppression by missing = excluded analysis at both time points. No treatment-emergent resistance was observed. There were no grade 3-4 study drug-related adverse events (AEs) or study drug-related serious AEs or deaths. Three AEs led to premature discontinuation; one (moderate abdominal discomfort) was attributed to the study drug by the investigator. At week 48, median changes from baseline in weight and estimated glomerular filtration rate were + 0.1 kg (interquartile range [IQR] - 1.0, 2.3) and - 6.0 ml/min (IQR - 10.2, 0.0), respectively. There were no clinically relevant changes from baseline to week 48 in fasting lipid parameters. Treatment satisfaction improved, and health-related quality of life was maintained from baseline through week 48. Median adherence to the study drug was 98.6% (IQR 96.0, 100).
Switching to B/F/TAF was effective and well tolerated through 48 weeks in virologically suppressed adults aged ≥ 65 years.
ClinicalTrials.gov identifier, NCT03405935.
我们报告了一项正在进行的研究的48周结果，该研究旨在评估将老年HIV感染者换用比克替拉韦/恩曲他滨/丙酚替诺福韦（B/F/TAF）的疗效和安全性。
这是一项为期96周的3b期开放标签单臂研究（GS-US-380-4449；NCT03405935）。将年龄≥65岁、病毒学得到抑制且正在接受elvitegravir/cobicistat/恩曲他滨/丙酚替诺福韦或基于富马酸替诺福韦二吡呋酯方案治疗的个体换用B/F/TAF。主要终点是第24周时HIV-1 RNA＜50拷贝/ml的参与者百分比。
86名参与者（中位年龄69岁[范围65 - 80岁]；87%为男性；95%为白人）在五个欧洲国家入组并接受治疗。第24周时病毒学抑制率为97.7%，第48周时为90.7%；无人的HIV-1 RNA≥50拷贝/ml，且在两个时间点通过缺失值 = 排除分析，100%的人实现了病毒学抑制。未观察到治疗中出现的耐药情况。未出现3 - 4级与研究药物相关的不良事件（AE）、与研究药物相关的严重AE或死亡。3例AE导致提前停药；其中1例（中度腹部不适）经研究者判定与研究药物有关。在第48周时，体重较基线的中位数变化为 + 0.1 kg（四分位间距[IQR] - 1.0，2.3），估计肾小球滤过率较基线的中位数变化为 - 6.0 ml/min（IQR - 10.2，0.0）。从基线到第48周，空腹血脂参数无临床相关变化。治疗满意度有所提高，从基线到第48周，与健康相关的生活质量得以维持。研究药物的中位依从性为98.6%（IQR 96.0，100）。
对于年龄≥65岁、病毒学得到抑制的成年人，换用B/F/TAF在48周内疗效显著且耐受性良好。
ClinicalTrials.gov标识符，NCT03405935。
