比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺在意大利常规临床护理中的有效性、安全性及患者报告结局：BICSTaR队列的12个月结果

Effectiveness, safety, and patient-reported outcomes of bictegravir/emtricitabine/tenofovir alafenamide in routine clinical care in Italy: 12-Month results from the BICSTaR cohort.

作者信息

Antinori Andrea, Marchetti Giulia, Esposito Vincenzo, Rusconi Stefano, Canetti Diana, Quiros-Roldan Eugenia, Candelaresi Bianca, Saracino Annalisa, Andreoni Massimo, Marongiu Andrea, Cassidy Tali, Thorpe David, Albini Laura, Caldera Roberto, Forcina Gabriele, Di Perri Giovanni

机构信息

HIV/AIDS Department, National Institute of Infectious Diseases, L. Spallanzani, IRCCS, Rome, Italy.

Clinic of Infectious Diseases, Department of Health Sciences, University of Milan, "ASST Santi Paolo e Carlo", Milan, Italy.

出版信息

Int J STD AIDS. 2025 Mar;36(4):309-318. doi: 10.1177/09564624241308372. Epub 2025 Jan 8.

DOI:10.1177/09564624241308372

PMID:39772928

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11877974/

Abstract

BACKGROUND

BICSTaR is a multi-national, observational cohort evaluating the effectiveness, safety, and patient-reported outcomes (PROs) in treatment-naïve (TN) and -experienced (TE) people with HIV-1 receiving bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in routine clinical care. We present the 12-month (M12) outcomes of the Italian BICSTaR cohort.

METHODS

Participants initiating B/F/TAF in routine care were prospectively followed. Outcomes included virological and immunologic effectiveness, drug-related adverse events (DRAEs), treatment persistence, and PROs using the HIV Symptom Index (HIV-SI) and the HIV Treatment Satisfaction Questionnaires (HIVTSQ).

RESULTS

= 201 were included (29 TN, 172 TE), 83% male, median age 38 years in TN, 48 years in TE. At baseline, 94% of TE had an HIV-1 RNA <50 cp/mL, 92% switched to B/F/TAF for simplification. Overall, 69% reported comorbidities (TN: 59%, TE: 70%). At M12, 88% (23/26) of TN and 96% (152/159) of TE had an HIV-1 RNA <50 cp/mL in the discontinuation = failure analysis (without emergence of resistance to B/F/TAF). Median CD4 count changes were +296 cells/µL (interquartile range [IQR], 118, 383) in TN, and +23 cells/µl (-137, 114) in TE. DRAEs were reported for 5% and led to discontinuation in 1%. M12 persistence on B/F/TAF was 97%. TN had a median HIV-SI bothersome symptom count decrease of -1.5 (IQR, -5.0, 0.0). Median treatment satisfaction change score was +29.0 (21, 30) in TE indicating an improvement.

CONCLUSIONS

In this real-world Italian cohort of mostly treatment-experienced people switching for simplification, B/F/TAF demonstrated high effectiveness and persistence over 12 months and confirmed the favourable safety profile shown in clinical trials.

TRIAL REGISTRATION

European cohort: EUPAS22185.

摘要

背景

BICSTaR是一项多国观察性队列研究，旨在评估在常规临床护理中，初治（TN）和经治（TE）的HIV-1感染者接受比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（B/F/TAF）治疗的有效性、安全性及患者报告结局（PRO）。我们展示了意大利BICSTaR队列的12个月（M12）结局。

方法

对在常规护理中开始使用B/F/TAF的参与者进行前瞻性随访。结局包括病毒学和免疫学有效性、药物相关不良事件（DRAE）、治疗持续性，以及使用HIV症状指数（HIV-SI）和HIV治疗满意度问卷（HIVTSQ）评估的PRO。

结果

共纳入201例（29例TN，172例TE），83%为男性，TN组中位年龄38岁，TE组中位年龄48岁。基线时，94%的TE患者HIV-1 RNA<50拷贝/mL，92%为简化治疗方案而换用B/F/TAF。总体而言，69%的患者报告有合并症（TN组：59%，TE组：70%）。在M12时，在停药=失败分析中（未出现对B/F/TAF的耐药），88%（23/26）的TN患者和96%（152/159）的TE患者HIV-1 RNA<50拷贝/mL。TN组CD4细胞计数中位数变化为+296个细胞/µL（四分位间距[IQR]，118，383），TE组为+23个细胞/µL（-137，114）。报告DRAE的患者占5%，因DRAE停药的患者占1%。B/F/TAF在M12时的治疗持续性为97%。TN组HIV-SI困扰症状计数中位数下降-1.5（IQR，-5.0，0.0）。TE组治疗满意度变化评分中位数为+29.0（21，30），表明有所改善。