简要报告：依非韦伦、拉替拉韦和多替拉韦在 HIV-1/TB 合并感染中的疗效和安全性。法国多中心回顾性队列研究。

Brief Report: Efficacy and Safety of Efavirenz, Raltegravir, and Dolutegravir in HIV-1/TB Coinfection. A Multicenter Retrospective Cohort Study in France.

机构信息

Department of Infectious Diseases, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France.

Department of Infectious Diseases, Hôpital Bichat-Claude Bernard, Assistance Publique Hôpitaux de Paris, Paris, France.

出版信息

J Acquir Immune Defic Syndr. 2022 Sep 1;91(1):85-90. doi: 10.1097/QAI.0000000000003024.

DOI:10.1097/QAI.0000000000003024

PMID:35616997

Abstract

BACKGROUND

There are limited data comparing the efficacy and safety of raltegravir and dolutegravir to that of efavirenz in HIV-1/tuberculosis (TB) coinfected patients.

METHODS

We conducted a 10-year retrospective study in 4 centers in France. We included all HIV-1/tuberculosis coinfected patients starting antiretroviral therapy with a rifampicin-based regimen, with a plasma HIV RNA level (VL) > 1000 copies/mL. The primary endpoint was the proportion of patients with virological success that is, with VL <50 copies/mL at W48 using an Intention-To-Treat analysis, using last-observation-carried-forward to impute missing data. We also assessed antiretroviral therapy safety, analyzing treatment discontinuation for adverse events.

RESULTS

Between 2010 and 2020, 117 patients were included. Thirty-nine (33.3%) were treated with raltegravir and 2 nucleoside reverse transcriptase inhibitors (NRTIs), 19 (16.2%) with dolutegravir (and 2 NRTIs) and 59 (50.4%) with efavirenz (and 2 NRTIs). At W48, the primary endpoint was achieved in 24 patients (61.5%) in the raltegravir group, in 12 (63.2%) in the dolutegravir group, and in 41 (69.5%) in the efavirenz group using an Intention-To-Treat analysis ( P = 0.68). Emergence of drug resistance in patients with virological failure, defined as a VL >50 copies/mL, was observed in 3 patients with efavirenz and one patient with raltegravir. Rate of treatment discontinuation for drug-related adverse events was 10.3%, 10.6%, 16.9% for raltegravir, dolutegravir and efavirenz respectively ( P = 0.67).

CONCLUSIONS

In this retrospective cohort study, raltegravir and dolutegravir yielded similar efficacy and safety results to efavirenz for the treatment of HIV-1/TB coinfected patients.

摘要

背景

比较拉替拉韦和多替拉韦与依非韦伦在 HIV-1/结核（TB）合并感染患者中的疗效和安全性的数据有限。

方法

我们在法国的 4 个中心进行了一项为期 10 年的回顾性研究。我们纳入了所有开始利福平为基础方案抗逆转录病毒治疗、血浆 HIV RNA 水平（VL）>1000 拷贝/ml 的 HIV-1/TB 合并感染患者。主要终点是使用意向治疗分析时，在第 48 周时病毒学应答（即 VL<50 拷贝/ml）的患者比例，采用最后观察向前推断缺失数据。我们还评估了抗逆转录病毒治疗的安全性，分析了因不良事件而停药的情况。

结果

2010 年至 2020 年间，共纳入 117 例患者。39 例（33.3%）患者接受拉替拉韦和 2 种核苷逆转录酶抑制剂（NRTIs）治疗，19 例（16.2%）患者接受多替拉韦（和 2 种 NRTIs）治疗，59 例（50.4%）患者接受依非韦伦（和 2 种 NRTIs）治疗。在第 48 周时，意向治疗分析显示，拉替拉韦组有 24 例（61.5%）患者达到主要终点，多替拉韦组有 12 例（63.2%）患者，依非韦伦组有 41 例（69.5%）患者（P=0.68）。在病毒学失败（定义为 VL>50 拷贝/ml）的患者中观察到 3 例依非韦伦和 1 例拉替拉韦患者出现耐药。因药物相关不良反应而停药的发生率分别为拉替拉韦、多替拉韦和依非韦伦组为 10.3%、10.6%和 16.9%（P=0.67）。