在经病毒学控制的 HIV 感染者中，从比克替拉韦/恩曲他滨/丙酚替诺福韦二吡呋酯转换为比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺富马酸盐后免疫重建和安全代谢特征：来自 BICTEL 队列的 96 周更新。

Immune Reconstitution and Safe Metabolic Profile after the Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate among Virologically Controlled PLWH: A 96 Week Update from the BICTEL Cohort.

机构信息

Department of Public Health and Infectious Diseases, Sapienza University of Rome, Policlinico Umberto I of Rome, 00185 Rome, Italy.

Department of Translational and Precision Medicine, Sapienza University of Rome, AOU Policlinico Umberto I of Rome, 00185 Rome, Italy.

出版信息

Viruses. 2023 May 23;15(6):1222. doi: 10.3390/v15061222.

BACKGROUND

Bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF) is a recommended once-daily single-tablet regimen for the treatment of people living with HIV (PLWH). We aimed to assess efficacy, safety, and tolerability of BIC/FTC/TAF among PLWH, with a specific focus on people older than 55 years.

METHODS

We recruited an observational retrospective real-life cohort, including all PLWH who underwent a therapeutic switch to BIC/FTC/TAF, independently from the previous treatment regimen (the BICTEL cohort). Longitudinal nonparametric analyses and linear models were built.

RESULTS

After 96 weeks of follow-up, 164 PLWH were included, with 106 older than 55. Both the intention-to-treat and the per-protocol analysis showed low rates of virologic failure, independent of the pre-switch anchor drug. At week 96, a significant increase in CD4 T cell count and in CD4/CD8 ratio was observed, inversely correlated with baseline immune status. Fasting serum lipid profile, total body weight, BMI, and hepatic function were not affected by the switch, without new onset of metabolic syndrome or weight gain. Compared to baseline, we observed a renal function worsening which is worthy of further follow-up.

CONCLUSION

BIC/FTC/TAF is an effective, safe, and well-tolerated switching strategy for PLWH, especially among those older than 55.

背景

比克替拉韦/恩曲他滨/丙酚替诺福韦富马酸盐（BIC/FTC/TAF）是一种推荐的每日一次的单片治疗方案，用于治疗人类免疫缺陷病毒（HIV）感染者（PLWH）。我们旨在评估 BIC/FTC/TAF 在 PLWH 中的疗效、安全性和耐受性，特别关注年龄大于 55 岁的人群。

方法

我们招募了一个观察性回顾性真实世界队列，包括所有接受 BIC/FTC/TAF 治疗转换的 PLWH，无论之前的治疗方案如何（BICTEL 队列）。进行了纵向非参数分析和线性模型构建。

结果

在 96 周的随访后，纳入了 164 名 PLWH，其中 106 名年龄大于 55 岁。意向治疗和方案分析均显示病毒学失败率较低，与转换前的锚定药物无关。在第 96 周时，观察到 CD4 T 细胞计数和 CD4/CD8 比值显著增加，与基线免疫状态呈负相关。空腹血脂谱、体重、BMI 和肝功能不受转换的影响，没有新发生的代谢综合征或体重增加。与基线相比，我们观察到肾功能恶化，需要进一步随访。