在欧洲，HIV 感染经治患者中整合酶抑制剂的有效性。

Effectiveness of integrase strand transfer inhibitors in HIV-infected treatment-experienced individuals across Europe.

机构信息

Infectious Diseases Unit, University Hospital of Siena, Siena, Italy.

University of Milan "La Statale", Milano, Italy.

出版信息

HIV Med. 2022 Aug;23(7):774-789. doi: 10.1111/hiv.13262. Epub 2022 Feb 24.

DOI:10.1111/hiv.13262

PMID:35199909

Abstract

OBJECTIVES

To explore the effectiveness and durability of integrase strand transfer inhibitor (INSTI)-based regimens in pre-treated subjects.

METHODS

Treatment-experienced individuals starting an INSTI-based regimen during 2012-2019 were selected from the INTEGRATE collaborative study. The time to virological failure [VF: one measurement of viral load (VL) ≥ 1000 copies/mL or two ≥ 50 copies/ml or one VL measurement ≥ 50 copies/mL followed by treatment change] and to INSTI discontinuation were evaluated.

RESULTS

Of 13 560 treatments analysed, 4284 were from INSTI-naïve, non-viraemic (IN-NV) individuals, 1465 were from INSTI-naïve, viraemic (IN-V) individuals, 6016 were from INSTI-experienced, non-viraemic (IE-NV) individuals and 1795 were from INSTI-experienced, viraemic (IE-V) individuals. Major INSTI drug resistance mutations (DRMs) were previously detected in 4/519 (0.8%) IN-NV, 3/394 (0.8%) IN-V, 7/1510 (0.5%) IE-NV and 25/935 (2.7%) IE-V individuals. The 1-year estimated probabilities of VF were 3.1% [95% confidence interval (CI): 2.5-3.8] in IN-NV, 18.4% (95% CI: 15.8-21.2) in IN-V, 4.2% (95% CI: 3.6-4.9) in IE-NV and 23.9% (95% CI: 20.9-26.9) in IE-V subjects. The 1-year estimated probabilities of INSTI discontinuation were 12.1% (95% CI: 11.1-13.0) in IN-NV, 19.6% (95% CI: 17.5-21.6) in IN-V, 10.8% (95% CI: 10.0-11.6) in IE-NV and 21.7% (95% CI: 19.7-23.5) in IE-V subjects.

CONCLUSIONS

Both VF and INSTI discontinuation occur at substantial rates in viraemic subjects. Detection of DRMs in a proportion of INSTI-experienced individuals makes INSTI resistance testing mandatory after failure.

摘要

目的

探索整合酶抑制剂（INSTI）为基础的方案在预先治疗的患者中的疗效和持久性。

方法

从 INTEGRATE 协作研究中选择了 2012 年至 2019 年期间开始使用 INSTI 为基础方案的治疗经验丰富的个体。评估病毒学失败（VF：一次病毒载量（VL）测量值≥1000 拷贝/ml 或两次≥50 拷贝/ml 或一次 VL 测量值≥50 拷贝/ml 后治疗改变）和 INSTI 停药的时间。

结果

在分析的 13560 种治疗中，4284 种来自 INSTI 初治、非病毒血症（IN-NV）个体，1465 种来自 INSTI 初治、病毒血症（IN-V）个体，6016 种来自 INSTI 经验丰富、非病毒血症（IE-NV）个体，1795 种来自 INSTI 经验丰富、病毒血症（IE-V）个体。在 4/519（0.8%）的 IN-NV、3/394（0.8%）的 IN-V、7/1510（0.5%）的 IE-NV 和 25/935（2.7%）的 IE-V 个体中，先前检测到主要 INSTI 耐药突变（DRMs）。IN-NV 中 1 年估计的 VF 发生率为 3.1%（95%置信区间[CI]：2.5-3.8），IN-V 中为 18.4%（95%CI：15.8-21.2），IE-NV 中为 4.2%（95%CI：3.6-4.9），IE-V 中为 23.9%（95%CI：20.9-26.9）。在 IN-NV 中，1 年估计的 INSTI 停药率为 12.1%（95%CI：11.1-13.0），在 IN-V 中为 19.6%（95%CI：17.5-21.6），在 IE-NV 中为 10.8%（95%CI：10.0-11.6），在 IE-V 中为 21.7%（95%CI：19.7-23.5）。