Yokomaku Yoshiyuki, Teruya Katsuji, Watanabe Dai, Endo Tomoyuki, Minami Rumi, Taguchi Nao, Cassidy Tali, Marongiu Andrea, Thorpe David, Shirasaka Takuma, Oka Shinichi
Clinical Research Center, NHO Nagoya Medical Center, Nagoya, Japan.
AIDS Clinical Center, National Center for Global Health and Medicine, Tokyo, Japan.
PLoS One. 2025 Jan 8;20(1):e0313338. doi: 10.1371/journal.pone.0313338. eCollection 2025.
BICSTaR (BICtegravir Single Tablet Regimen) is an ongoing, observational cohort study assessing the virologic effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-experienced (TE) and treatment-naïve (TN) people with HIV across 14 countries over 24 months. We present 12-month outcomes from participants in the BICSTaR Japan cohort. Retrospective and prospective data were pooled from people with HIV aged ≥20 years receiving B/F/TAF within routine clinical care in Japan. Outcomes included virologic effectiveness (primary endpoint; HIV-1 RNA <50 copies/mL), CD4 count, CD4/CD8 ratio, drug-related adverse events (DRAEs), persistence, and patient-reported outcomes (prospective TN cohort only). Overall, 200 participants were enrolled and included in the 12-month analysis population (150 retrospective, 50 prospective; 116 TN and 84 TE). Most participants were male at birth (99%); median age was 34 years in TN and 45 years in TE participants. At 12 months, virologic effectiveness was high: 92% (90/98) of TN and 95% (72/76) of TE participants had HIV-1 RNA <50 copies/mL (missing = excluded analysis). Median (quartile [Q]1, Q3) CD4 cell count increased by +202.0 (126.0, 311.0) cells/μL in TN (p<0.001) and +11.0 (-60.0, 87.0) cells/μL in TE (p = 0.380) participants. Through 12 months, DRAEs were reported by 13% (25/200) of all participants (16% [18/116] TN, 8% [7/84] TE); diarrhea, weight gain, and headache were the most common. Most DRAEs were mild in severity and no severe DRAEs were reported. One TN participant (<1%; 1/116) and two TE participants (2%; 2/84) discontinued B/F/TAF due to DRAEs (macrocytic anemia, vertigo, diarrhea, and headache). Treatment persistence at 12 months exceeded 98% in both TN and TE participants. In prospective TN participants, improvements in bothersome symptom count and quality-of-life measures were observed. B/F/TAF demonstrated high levels of virologic effectiveness and tolerability in people with HIV treated as part of routine clinical care in Japan.
BICSTaR（比克替拉韦单片治疗方案）是一项正在进行的观察性队列研究，旨在评估比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（B/F/TAF）在14个国家24个月内对有治疗经验（TE）和初治（TN）的HIV感染者的病毒学疗效和安全性。我们展示了BICSTaR日本队列参与者的12个月结果。回顾性和前瞻性数据来自日本常规临床护理中年龄≥20岁接受B/F/TAF治疗的HIV感染者。结果包括病毒学疗效（主要终点；HIV-1 RNA<50拷贝/mL）、CD4细胞计数、CD4/CD8比值、药物相关不良事件（DRAEs）、治疗持久性以及患者报告的结果（仅前瞻性TN队列）。总体而言，200名参与者被纳入12个月分析人群（150名回顾性，50名前瞻性；116名TN和84名TE）。大多数参与者出生时为男性（99%）；TN参与者的中位年龄为34岁，TE参与者为45岁。在12个月时，病毒学疗效很高：TN参与者中有92%（90/98）、TE参与者中有95%（72/76）的HIV-1 RNA<50拷贝/mL（缺失值=排除分析）。TN参与者的CD4细胞计数中位数（四分位数[Q]1，Q3）增加了+202.0（126.0，311.0）个细胞/μL（p<0.001），TE参与者增加了+11.0（-60.0，87.0）个细胞/μL（p = 0.380）。在12个月期间，所有参与者中有13%（25/200）报告了DRAEs（TN组为16%[18/116]，TE组为8%[7/84]）；腹泻、体重增加和头痛最为常见。大多数DRAEs严重程度为轻度，未报告严重DRAEs。一名TN参与者（<1%；1/116）和两名TE参与者（2%；2/84）因DRAEs（大细胞性贫血头晕、腹泻和头痛）停用了B/F/TAF。TN和TE参与者在12个月时的治疗持久性均超过98%。在前瞻性TN参与者中，观察到令人烦恼的症状数量和生活质量指标有所改善。在日本作为常规临床护理一部分接受治疗的HIV感染者中，B/F/TAF显示出高水平的病毒学疗效和耐受性。
