Sun Hsin-Yun, Lin Ya-Ting, Chang Wen-Chi, Liu Wen-Chun, Su Yi-Ching, Kuo Ching-Hua, Hung Chien-Ching
Department of Internal Medicine, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
School of Pharmacy, National Taiwan University College of Medicine, Taipei, Taiwan.
J Antimicrob Chemother. 2025 Aug 1;80(8):2179-2186. doi: 10.1093/jac/dkaf186.
This open-label, randomized clinical trial determined plasma bictegravir trough concentration (Ctrough) and compared virological efficacy with daily bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) versus BIC/FTC/TAF taken five-days-on-two-days-off (FOTO) in people with HIV (PWH).
Sixty PWH aged ≥20 years with plasma HIV RNA load (PVL) of <50 copies/mL for ≥6 months after having received daily BIC/FTC/TAF were randomized (1:1) to daily versus FOTO BIC/FTC/TAF. The primary endpoint was plasma bictegravir Ctrough above the in vitro protein-adjusted 95% effective concentration (162 ng/mL) at Weeks 4, 28 and 52. The secondary endpoints were PVL < 50 copies/mL and weight and renal and metabolic parameters at the same time points. After Week 52, all participants entered the 48-week extension phase to receive FOTO BIC/FTC/TAF.
There were no significant differences in the baseline clinical characteristics, including drug-metabolizing gene polymorphisms, between the two groups. In the FOTO group, 90%, 93.3% and 100% of participants achieved a bictegravir Ctrough of >162 ng/mL at Weeks 4, 28 and 52, respectively. In intention-to-treat analysis, PVL of <50 copies/mL at Weeks 4, 28 and 52 was achieved by 100%, 93.3% and 100%, respectively, in the FOTO group, compared with 96.7%, 93.3% and 96.7% in the daily group. All five participants in the FOTO group with bictegravir Ctrough of <162 ng/mL at Weeks 4 and 28 maintained PVL <50 copies/mL. Of 57 (95.0%) participants who entered the extension phase, 56 (98.2%) completed the study and all maintained PVL <50 copies/mL at extension Week 48.
We showed PWH could successfully maintain sufficient bictegravir exposure and virological suppression with FOTO BIC/FTC/TAF.
NCT06773754.
本开放标签随机临床试验测定了血浆比克替拉韦谷浓度（Ctrough），并比较了在感染HIV者（PWH）中，每日服用比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（BIC/FTC/TAF）与采用服药5天停药2天（FOTO）方案的BIC/FTC/TAF的病毒学疗效。
60名年龄≥20岁、在每日服用BIC/FTC/TAF后血浆HIV RNA载量（PVL）<50拷贝/mL达≥6个月的PWH被随机（1:1）分为每日服用组和FOTO方案的BIC/FTC/TAF组。主要终点是在第4、28和52周时，血浆比克替拉韦Ctrough高于体外蛋白校正后的95%有效浓度（162 ng/mL）。次要终点是在相同时间点PVL<50拷贝/mL以及体重、肾脏和代谢参数。在第52周后，所有参与者进入48周的延长期，接受FOTO方案的BIC/FTC/TAF。
两组之间在基线临床特征（包括药物代谢基因多态性）方面无显著差异。在FOTO组中，分别有90%、93.3%和100%的参与者在第4、28和52周时比克替拉韦Ctrough>162 ng/mL。在意向性分析中，FOTO组在第4、28和52周时分别有100%、93.3%和100%的参与者实现PVL<50拷贝/mL，而每日服用组分别为96.7%、93.3%和96.7%。FOTO组中在第4周和第28周比克替拉韦Ctrough<162 ng/mL的所有5名参与者均维持PVL<50拷贝/mL。在进入延长期的57名（95.0%）参与者中，56名（98.2%）完成了研究，并且在延长期第48周时均维持PVL<50拷贝/mL。
我们表明，PWH采用FOTO方案的BIC/FTC/TAF能够成功维持足够的比克替拉韦暴露和病毒学抑制。
NCT06773754。
